| Primary | Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period. | The CFA is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Higher values indicated a better response. Change is calculated as (DB CFA-Baseline CFA). | The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement. | Posted | | Mean | Standard Deviation | Percentage | | End of double-blind period (5-7 days) | | | | ID | Title | Description |
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| OG000 | Pancrelipase (DB) | Pancrelipase delayed release capsules given during the Double-Blind period | | OG001 | Placebo (DB) | Placebo group given during the Double-Blind period |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00031.93± 18.57
- OG0018.72± 12.44
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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 |
|---|
| The following null hypothesis was tested (μ0 and μ1 denote the treatment group means respectively in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase delayed release capsules are equal). The hypothesis corresponded to the primary objective to show superior efficacy of pancrelipase delayed release capsules over placebo. A non-parametric ANCOVA was used because the necessary assumptions were not met for the parametric ANCOVA. | Non parametric ANCOVA | | <0.0001 | | | | | | | 95 | | | | | | No | Superiority or Other | | |
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| Secondary | Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period. | The CNA is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Higher values indicated a better response. Change is calculated as (DB CNA-Baseline CNA). | The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement. | Posted | | Mean | Standard Deviation | Percentage | | End of double-blind period (5-7 days) | | | | ID | Title | Description |
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| OG000 | Pancrelipase (DB) | Pancrelipase delayed release capsules given during the Double-Blind period | | OG001 | Placebo (DB) | Placebo group given during the Double-Blind period |
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| Secondary | Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period. | Total amount of fat excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool fat - Baseline stool fat). | The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement. | Posted | | Least Squares Mean | Standard Error | Grammes | | End of double-blind period (5-7 days) | | | | ID | Title | Description |
|---|
| OG000 | Pancrelipase (DB) | Pancrelipase delayed release capsules given during the Double-Blind period | | OG001 | Placebo (DB) | Placebo group given during the Double-Blind period |
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| Secondary | Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period. | Total amount of nitrogen excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool nitrogen - Baseline stool nitrogen). | The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement. | Posted | | Least Squares Mean | Standard Error | Grammes | | End of double-period (5-7 days) | | | | ID | Title | Description |
|---|
| OG000 | Pancrelipase (DB) | Pancrelipase delayed release capsules given during the Double-Blind period | | OG001 | Placebo (DB) | Placebo group given during the Double-Blind period |
| |
| Secondary | Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period | Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response. Change was calculated as (DB stool frequency - Baseline Stool frequency). | The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement. | Posted | | Least Squares Mean | Standard Error | Number | | End of double-period (5-7 days) | | | | ID | Title | Description |
|---|
| OG000 | Pancrelipase (DB) | Pancrelipase delayed release capsules given during the Double-Blind period | | OG001 | Placebo (DB) | Placebo group given during the Double-Blind period |
| |
| Secondary | Abdominal Pain at the End of the Double-blind Period. | 4- point ordinal scale on this symptom from 0 (No Abdominal pain) to 3 (Severe abdominal pain). | The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement. | Posted | | Number | | Participants | | End of double-period (5-7 days) | | | | ID | Title | Description |
|---|
| OG000 | Pancrelipase (DB) | Pancrelipase delayed release capsules given during the Double-Blind period | | OG001 | Placebo (DB) | Placebo group given during the Double-Blind period |
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| Secondary | Stool Consistency at the End of the Double-blind Period | 4- point ordinal scale on this symptom from 0 (Hard) to 3 (Watery). | The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement. | Posted | | Number | | Participants | | End of double-period (5-7 days) | | | | ID | Title | Description |
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| OG000 | Pancrelipase (DB) | Pancrelipase delayed release capsules given during the Double-Blind period | | OG001 | Placebo (DB) | Placebo group given during the Double-Blind period |
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| Secondary | Flatulence at the End of Double-blind Period | 4- point ordinal scale on this symptom from 0 (None) to 3 (Severe). | The analysis was done on the Full Analysis sample. Full Analysis Population consists of all subjects who were allocated to the treatment and had data for at least one post-baseline assessment of any efficacy measurement. | Posted | | Number | | Participants | | End of double-period (5-7 days) | | | | ID | Title | Description |
|---|
| OG000 | Pancrelipase (DB) | Pancrelipase delayed release capsules given during the Double-Blind period | | OG001 | Placebo (DB) | Placebo group given during the Double-Blind period |
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| Other Pre-specified | Change of Stool Frequency Between "Original" Baseline and End of Open-label Period (OL) | Stool frequency is the average of the daily number of stools recorded during the OL period. Lower values indicate a better response. Change was calculated as (OL stool frequency - Baseline stool frequency). | This analysis is done on the Open-Label period of 6 months. | Posted | | Mean | Standard Deviation | Number | | 27 weeks | | | | ID | Title | Description |
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| OG000 | Pancrelipase (OL) | Pancrelipase delayed during Open-label. Dosing is directed by the investigator. |
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