| Primary | Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 1 | The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). | Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. | Posted | | Mean | Standard Deviation | Score on a scale | | At baseline (prior to intake of first tablet of study medication in episode 1) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours | | | | ID | Title | Description |
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| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-2.7± 3.10
- OG001-3.1± 3.05
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| | 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 |
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| A model included fixed, categorical effects of treatment group, episode, interval and center, as well as the treatment-by-episode interaction, with the covariate of baseline intensity of Abdominal pain associated with cramping . An unstructured covariance structure was used to model the within-patient errors. | Mixed effect model | | 0.0156 | | Adjusted mean difference | -0.7 | Standard Error of the Mean | 0.29 | 2-Sided | 95 | -1.3 | -0.1 | | | The adjusted mean difference between Hyoscine butylbromide minus Placebo was calculated. | | Other | |
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| Primary | Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 2 | The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). | Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. | Posted | | Mean | Standard Deviation | Score on a scale | | At baseline (prior to intake of first tablet of study medication in episode 2) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours. | | | | ID | Title | Description |
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| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Primary | Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 1 | The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). | Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. | Posted | | Mean | Standard Deviation | Score * hours | | At baseline (prior to intake of first tablet of study medication for episode 1) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter. | | | | ID | Title | Description |
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| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Primary | Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 2 | The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). | Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. | Posted | | Mean | Standard Deviation | Score * hours | | At baseline (prior to intake of first tablet of study medication for episode 2) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter. | | | | ID | Title | Description |
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| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Primary | Percentage of Participants With Response of "no Pain" Based on Numeric Pain Rating Scale (NPRS) in Episode 1 | The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Responses of "no pain" (NPRS = 0) based on the 0 to 10 point NPRS scale were summarized. | Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. | Posted | | Number | | Percentage of participants | | At 4 hours after intake of first tablet of study medication in episode 1 | | | | ID | Title | Description |
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| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Primary | Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 2 | The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Responses of "no pain" (NPRS = 0) based on the 0 to 10 point NPRS scale were summarized. | Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. | Posted | | Number | | Percentage of participants | | At 4 hours after intake of first tablet of study medication in episode 2 | | | | ID | Title | Description |
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| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Primary | Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 1 | At episode 1, after the intake of first tablet of study medication, the patient then responded to the question of "Compared to just before you took the first tablet of study medication, how would you rate your abdominal pain associated with cramping now?" based on the Patient global impression of change (PGI-C), using the available responses: "Much better", "Somewhat better", "A little better", "No change", "A little worse", and "Somewhat worse". | Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. | Posted | | Number | | Percentage of participants | | At 4 hours after intake of first tablet of study medication in episode 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Primary | Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 2 | At episode 2, after the intake of first tablet of study medication, the patient then responded to the question of "Compared to just before you took the first tablet of study medication, how would you rate your abdominal pain associated with cramping now?" based on the Patient global impression of change (PGI-C), using the available responses: "Much better", "Somewhat better", "A little better", "No change", "A little worse", and "Somewhat worse". | Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. | Posted | | Number | | Percentage of participants | | At 4 hours after intake of first tablet of study medication in episode 2 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Primary | Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 1 | At episode 1, after the intake of first tablet of study medication, the patient then responded to the question of "Overall, how satisfied were you with the medication in terms of effectiveness for this episode?" based on the 4-point Verbal rating scale (VRS) using the available response: "Very Satisfied", "Satisfied", "Dissatisfied", and "Very Dissatisfied". | Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. | Posted | | Number | | Percentage of participants | | At 4 hours after intake of first tablet of study medication in episode 1 | | | | ID | Title | Description |
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| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Primary | Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 2 | At episode 2, after the intake of first tablet of study medication, the patient then responded to the question of "Overall, how satisfied were you with the medication in terms of effectiveness for this episode?" based on the 4-point Verbal rating scale (VRS) using the available response: "Very Satisfied", "Satisfied", "Dissatisfied", and "Very Dissatisfied". | Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. | Posted | | Number | | Percentage of participants | | At 4 hours after intake of first tablet of study medication in episode 2 | | | | ID | Title | Description |
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| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Primary | Time to Relief in Episode 1 | Time from intake of first tablet of study medication to first response of "no pain" (numeric pain rating scale (NPRS) = 0) in episode 1. | Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. | Posted | | Median | 95% Confidence Interval | Minutes | | From intake of first tablet of study medication up to 4 hours thereafter in episode 1 | | | | ID | Title | Description |
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| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Primary | Time to Relief in Episode 2 | Time from intake of first tablet of study medication to first response of "no pain" (numeric pain rating scale (NPRS) = 0) in episode 2. | Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. | Posted | | Median | 95% Confidence Interval | Minutes | | From intake of first tablet of study medication up to 4 hours thereafter in episode 2 | | | | ID | Title | Description |
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| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Primary | Number of Tablets of Study Medication Taken | Number of tablets of study medication taken in each of the two episode. | Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. | Posted | | Mean | Standard Deviation | Tablets | | From intake of first tablet of study medication up to 4 hours thereafter in each episode. | | | | ID | Title | Description |
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| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Secondary | Percentage of Patients With Drug-related Adverse Events | | Treated set: This patient set includes all randomized patients who were dispensed study medication during treatment period and were documented to have taken at least one dose of investigational treatment. | Posted | | Number | | Percentage of participants | | From the first dose of study medication until 3 days after the last dose for each episode. Up to 8 days. | | | | ID | Title | Description |
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| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Secondary | Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1 | Patient's global assessment of tolerability following treatment of an episode of Abdominal pain associated with cramping (APC) was based on a 4-point Verbal rating scale (VRS) in patient's response to the question, "Overall, how satisfied were you with the medication in terms of side effects during this episode?" ("Very Satisfied," "Satisfied," "Dissatisfied," "Very Dissatisfied"). | Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. | Posted | | Count of Participants | | Participants | | At 4 hours after intake of first tablet of study medication in episode 1 | | | | ID | Title | Description |
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| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Secondary | Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2 | Patient's global assessment of tolerability following treatment of an episode of Abdominal pain associated with cramping (APC) was based on a 4-point Verbal rating scale (VRS) in patient's response to the question, "Overall, how satisfied were you with the medication in terms of side effects during this episode?" ("Very Satisfied," "Satisfied," "Dissatisfied," "Very Dissatisfied") | Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization. | Posted | | Count of Participants | | Participants | | At 4 hours after intake of first tablet of study medication in episode 2 | | | | ID | Title | Description |
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| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Secondary | Change From Baseline to End of Study Visit in Systolic Blood Pressure | Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in systolic blood pressure. | Treated set: This patient set includes all randomized patients who were dispensed study medication during treatment period and were documented to have taken at least one dose of investigational treatment. | Posted | | Mean | Standard Deviation | millimetre of mercury (mmHg) | | At baseline (intake of the first tablet of trial medication in the study) and day 28 (end of study visit) | | | | ID | Title | Description |
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| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Secondary | Change From Baseline to End of Study Visit in Diastolic Blood Pressure | Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in diastolic blood pressure. | Treated set: This patient set includes all randomized patients who were dispensed study medication during treatment period and were documented to have taken at least one dose of investigational treatment. | Posted | | Mean | Standard Deviation | millimetre of mercury (mmHg) | | At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Secondary | Change From Baseline to End of Study Visit in Pulse Rate | Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in pulse rate. | Treated set: This patient set includes all randomized patients who were dispensed study medication during treatment period and were documented to have taken at least one dose of investigational treatment. | Posted | | Mean | Standard Deviation | beats per minute (bpm) | | At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit | | | | ID | Title | Description |
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| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Secondary | Change From Baseline to End of Study Visit in Body Temperature | Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in body temperature. | Treated set: This patient set includes all randomized patients who were dispensed study medication during treatment period and were documented to have taken at least one dose of investigational treatment. | Posted | | Mean | Standard Deviation | celsius | | At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit | | | | ID | Title | Description |
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| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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| Secondary | Change From Baseline to End of Study Visit in Respiratory Rate | Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in respiratory rate. | Treated set: This patient set includes all randomized patients who were dispensed study medication during treatment period and were documented to have taken at least one dose of investigational treatment. | Posted | | Mean | Standard Deviation | breaths per minute | | At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit | | | | ID | Title | Description |
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| OG000 | Placebo | Up to 5 film-coated tablets of 20 milligram (mg) matching placebo (Tota up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. | | OG001 | Hyoscine Butylbromide (Buscopan®) 20 mg | Up to 5 film-coated tablets of 20 milligram (mg) of Hyoscine butylbromide (Buscopan®) (Total up to 100 mg) were administered orally per episode. One or two episodes of Abdominal pain associated with cramping (APC) were treated up to 2 hours each within 4 weeks. |
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