| Primary | Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period | A Complete Spontaneous Bowel Movement (CSBM) is a complete non-rescue medication-induced stool. The number of CSBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data. | Full Analysis Set (FAS): All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure | Posted | | Least Squares Mean | Standard Error | CSBMs per week | | 4 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001.9± 0.34
- OG0015.2± 0.27
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate | ANCOVA | | <0.0001 | Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs). | Mean Difference (Final Values) | 3.3 | Standard Error of the Mean | 0.36 | | 95 | 2.6 | 4.0 | | | Means are adjusted for center effects and baseline value | No | Superiority or Other | |
|
| Secondary | Number of CSBMs at Week 1 | The number of CSBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | CSBMs per week | | Week 1 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of CSBMs at Week 2 | The number of CSBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | CSBMs per week | | Week 2 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of CSBMs at Week 3 | The number of CSBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | CSBMs per week | | Week 3 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of CSBMs at Week 4 | The number of CSBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | CSBMs per week | | Week 4 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Mean Number of SBMs Per Week Over the 4 Weeks Treatment Period | A Spontaneous Bowel Movement (SBM) is a non-rescue medication-induced stool. The number of SBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | SBMs per week | | 4 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of SBMs at Week 1 | The number of SBMs at week 1 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | SBMs per week | | Week 1 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of SBMs at Week 2 | The number of SBMs at week 2 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | SBMs per week | | Week 2 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of SBMs at Week 3 | The number of SBMs at week 3 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | SBMs per week | | Week 3 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of SBMs at Week 4 | The number of SBMs at week 4 was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | SBMs per week | | Week 4 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Time to the First SBM Following the First Dose of Study Medication (SM) | The time to the first SBM following the first dose of SM was captured by the eDiary. The time was censored by the time of intake of rescue medication (RM), the time of premature discontinuation or the end of treatment whatever was minimal. | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Median | 95% Confidence Interval | Hours | | Time of first dose of SM up to 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With an Increase of at Least 1 in the Mean Number of CSBMs Per Week Over the 4 Weeks Treatment Period Compared to Baseline | | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With an Increase of at Least 1 CSBM at Week 1 Compared to Baseline | | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 1 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With an Increase of at Least 1 CSBM at Week 2 Compared to Baseline | | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 2 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With an Increase of at Least 1 CSBM at Week 3 Compared to Baseline | | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 3 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With an Increase of at Least 1 CSBM at Week 4 Compared to Baseline | | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 4 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With a Mean of at Least 1 CSBM a Day Over the 4 Weeks Treatment Period | | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With a Mean of at Least 3 CSBMs a Week Over the 4 Weeks Treatment Period | | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Premature Withdrawals Over the 4 Weeks Treatment Period | | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Premature Withdrawals at Week 1 in the Treatment Period | | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Week 1 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Premature Withdrawals at Week 2 in the Treatment Period | | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Week 2 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Premature Withdrawals at Week 3 in the Treatment Period | | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Week 3 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Premature Withdrawals at Week 4 in the Treatment Period | | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Week 4 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants Using Rescue Medication Over the 4 Weeks Treatment Period | | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants Using Rescue Medication at Week 1 in the Treatment Period | | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Week 1 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants Using Rescue Medication at Week 2 in the Treatment Period | | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Week 2 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants Using Rescue Medication at Week 3 in the Treatment Period | | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Week 3 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants Using Rescue Medication at Week 4 in the Treatment Period | | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Week 4 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 1 | The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 1 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 2 | The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 2 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 3 | The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 3 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 4 | The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 4 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 1 | The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 1 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 2 | The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 2 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 3 | The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 3 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 4 | The score on the 7-point Bristol Stool Form Scale from Type 1 (hard, lumpy stool) to Type 7 (watery stool) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 4 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 1 | The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 1 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 2 | The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 2 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 3 | The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 3 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 4 | The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 4 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 1 | The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 1 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 2 | The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 2 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 3 | The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 3 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 4 | The score on a 5-point ordinal verbal rating scale from 0 (absent) to 4 (very severe) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 4 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 1 | The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 1 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 2 | The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 2 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 3 | The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 3 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 4 | The score on a 2-point ordinal verbal rating scale from 0 (no) to 1 (yes) specifying patient's symptom assessment associated with each bowel movement was averaged over the day and then averaged over the days in the corresponding week. | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and week 4 in treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline | Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 1 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline | Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 2 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline | Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 3 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline | Improved / unchanged / worsened overall satisfaction is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (A very great deal satisfied) to 4 (Not at all satisfied) at the corresponding week in comparison to baseline | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 4 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline | Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 1 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline | Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 2 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline | Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 3 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline | Reduced / unchanged / increased bothersomeness of constipation is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 4 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline | Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 1 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline | Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 2 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline | Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 3 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline | Reduced / unchanged / increased bothersomeness of abdominal bloating is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 4 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline | Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 1 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline | Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 2 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline | Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 3 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline | Reduced / unchanged / increased bothersomeness of abdominal discomfort is a decreased / unchanged / increased score on a 5-point ordinal VRS: 0 (Not at all bothersome) to 4 (A very great deal bothersome) at the corresponding week in comparison to baseline | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | Baseline and week 4 in the treatment period | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator | Final global assessment scale range: 1 (good) to 4 (bad), ordinal | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient | Final global assessment scale range: 1 (good) to 4 (bad), ordinal | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator | Final global assessment scale range: 1 (good) to 4 (bad), ordinal | Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient | Final global assessment scale range: 1 (good) to 4 (bad), ordinal | Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure | Posted | | Number | | Participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the SF-36 Dimension 'Physical Functioning' | The dimension is a sum of 10 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Physical Problems' | The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the SF-36 Dimension 'Bodily Pain' | The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the SF-36 Dimension 'General Health' | The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health. | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the SF-36 Dimension 'Vitality' | The dimension is a sum of 4 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health. | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the SF-36 Dimension 'Social Functioning' | The dimension is a sum of 2 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Emotional Problems' | The dimension is a sum of 3 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health. | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the SF-36 Dimension 'Mental Health' | The dimension is a sum of 5 single items and then transferred to a scale ranging from 0 to 100. Single item scores are inverted, if applicable, to ensure that a higher score indicates a better health. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the SF-36 Mental Component Scale (MCS) | The MCS is a summary scale of the dimensions vitality, social functioning, role-emotional, and mental health. The component scale is norm-based to a standard population. A higher score indicates a better health. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the SF-36 Physical Component Scale (PCS) | The PCS is a summary scale of the subscales physical functioning, role-physical, bodily pain, and general health. The component scale is norm-based to a standard population. A higher score indicates a better health. | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the PAC-QoL Subscale 'Worries and Concerns' | The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the PAC-QoL Subscale 'Physical Discomfort' | The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the PAC-QoL Subscale 'Psychosocial Discomfort' | The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL | Patients from FAS ( = All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the PAC-QoL Subscale 'Satisfaction' | The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline in the PAC-QoL Overall Score | The PAC-QoL is a 28-item (5-point Likert scale ranging from 0 (none of the time or not at all) to 4 (all of the time or extremely). Single item scores are inverted, if applicable, to ensure that a lower score indicates a better QoL | Patients from FAS (= All randomised patients, who recorded at least one dose of trial medication in the eDiary and provided any data for the primary outcome measure), who provided data for the underlying outcome measure | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline for Sodium (Normalized Value) | Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range | Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline for Potassium (Normalized Value) | Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range | Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |
| Secondary | Change From Baseline for Chloride (Normalized Value) | Normalized value: the reported laboratory value is converted by linear transformation to a preferred unit and then linear-transformed with respect to the standard reference range | Treated patients ( = All randomised patients, who took at least one dose of trial medication), who provided data for the underlying outcome measure | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Two bisacodyl-matching 5 mg placebo tablets once daily | | OG001 | Bisacodyl | Two bisacodyl 5 mg tablets once daily |
| |