Trial · NCT00414908
A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy
NCT00414908, Phase 3, Completed, Solvay Pharmaceuticals; results first posted 2009-09-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy. Trials, record NCT00414908. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00414908
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy
- NCT number
- NCT00414908
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 52 participants, actual
- Lead sponsor
- Solvay Pharmaceuticals
- Conditions
- Chronic Pancreatitis, Pancreatectomy, Pancreatic Exocrine Insufficiency
- Interventions
- Pancrelipase delayed release capsule, Placebo Comparator
- First posted
- 2006-12-22
- Last updated
- 2011-08-10
- Other registries' IDs
- eudract:2004-000227-15
- Results first posted
- 2009-09-16
- Limitations and caveats
Only treatment emergent events have been presented. They are defined as events started at or after the 1st administration of study medication and includes events started prior to the 1st administration but which worsened after the 1st intake.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period. | End of double-blind period (5-7 days) | 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). |
| Secondary | Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period. | End of double-blind period (5-7 days) | 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). |
| Secondary | Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period. | End of double-blind period (5-7 days) | 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). |
| Secondary | Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period. | End of double-period (5-7 days) | 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). |
| Secondary | Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period | End of double-period (5-7 days) | 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). |
| Secondary | Abdominal Pain at the End of the Double-blind Period. | End of double-period (5-7 days) | 4- point ordinal scale on this symptom from 0 (No Abdominal pain) to 3 (Severe abdominal pain). |
| Secondary | Stool Consistency at the End of the Double-blind Period | End of double-period (5-7 days) | 4- point ordinal scale on this symptom from 0 (Hard) to 3 (Watery). |
| Secondary | Flatulence at the End of Double-blind Period | End of double-period (5-7 days) | 4- point ordinal scale on this symptom from 0 (None) to 3 (Severe). |
| Other | Change of Stool Frequency Between "Original" Baseline and End of Open-label Period (OL) | 27 weeks | 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). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period. | End of double-blind period (5-7 days) | 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. | Percentage | MEAN |
| SECONDARY | Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period. | End of double-blind period (5-7 days) | 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. | Percentage | MEAN |
| SECONDARY | Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period. | End of double-blind period (5-7 days) | 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. | Grammes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period. | End of double-period (5-7 days) | 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. | Grammes | LEAST_SQUARES_MEAN |
| SECONDARY | Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period | End of double-period (5-7 days) | 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. | Number | LEAST_SQUARES_MEAN |
| SECONDARY | Abdominal Pain at the End of the Double-blind Period. | End of double-period (5-7 days) | 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. | Participants | NUMBER |
| SECONDARY | Stool Consistency at the End of the Double-blind Period | End of double-period (5-7 days) | 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. | Participants | NUMBER |
| SECONDARY | Flatulence at the End of Double-blind Period | End of double-period (5-7 days) | 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. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Change of Stool Frequency Between Original Baseline and End of Open-label Period (OL) | 27 weeks | This analysis is done on the Open-Label period of 6 months. | Number | MEAN |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period. | Pancrelipase (DB) | 31.93 | Standard Deviation 18.57 | Percentage | |
| Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period. | Placebo (DB) | 8.72 | Standard Deviation 12.44 | Percentage | |
| Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period. | Pancrelipase (DB) | 35.23 | Standard Deviation 29.05 | Percentage | |
| Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period. | Placebo (DB) | 8.85 | Standard Deviation 28.04 | Percentage | |
| Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period. | Pancrelipase (DB) | -147.08 | Standard Error 12.71 | Grammes | |
| Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period. | Placebo (DB) | -34.62 | Standard Error 11.47 | Grammes | |
| Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period. | Pancrelipase (DB) | -17.55 | Standard Error 2.06 | Grammes | |
| Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period. | Placebo (DB) | -5.87 | Standard Error 1.85 | Grammes | |
| Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period | Pancrelipase (DB) | -0.55 | Standard Error 0.19 | Number | |
| Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period | Placebo (DB) | 0.20 | Standard Error 0.17 | Number |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pancrelipase (DB) | 25 | |
| Overall Study | STARTED | Placebo (DB) | 29 | |
| Overall Study | COMPLETED | Pancrelipase (DB) | 24 | |
| Overall Study | COMPLETED | Placebo (DB) | 28 | |
| Overall Study | NOT COMPLETED | Pancrelipase (DB) | 1 | |
| Overall Study | NOT COMPLETED | Placebo (DB) | 1 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hyperglycaemic conditions NEC | Metabolism and nutrition disorders | Pancrelipase (DB) | 1 | 24 | |
| other | Hyperglycaemic conditions NEC | Metabolism and nutrition disorders | Placebo (DB) | 2 | 28 | |
| other | Hyperglycaemic conditions NEC | Metabolism and nutrition disorders | Pancrelipase (OL) | 0 | 51 | |
| other | Upper respiratory Tract infections | Infections and infestations | Pancrelipase (DB) | 0 | 24 | |
| other | Upper respiratory Tract infections | Infections and infestations | Placebo (DB) | 0 | 28 | |
| other | Upper respiratory Tract infections | Infections and infestations | Pancrelipase (OL) | 4 | 51 | |
| serious | Acute and Chronic Pancreatitis | Gastrointestinal disorders | Pancrelipase (DB) | 0 | 24 | |
| serious | Acute and Chronic Pancreatitis | Gastrointestinal disorders | Placebo (DB) | 0 | 28 | |
| serious | Acute and Chronic Pancreatitis | Gastrointestinal disorders | Pancrelipase (OL) | 1 | 51 | |
| serious | Lower Limb Fractures and dislocations | Injury, poisoning and procedural complications | Pancrelipase (DB) | 0 | 24 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pancrelipase (DB) | ||
| Total, all-cause mortality | Placebo (DB) | ||
| Total, all-cause mortality | Pancrelipase (OL) | ||
| Total, other adverse events | Pancrelipase (DB) | 1 | 24 |
| Total, other adverse events | Placebo (DB) | 2 | 28 |
| Total, other adverse events | Pancrelipase (OL) | 4 | 51 |
| Total, serious adverse events | Pancrelipase (DB) | 0 | 24 |
| Total, serious adverse events | Placebo (DB) | 0 | 28 |
| Total, serious adverse events | Pancrelipase (OL) | 7 | 51 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00414908
GET https://conductscience.org/api/trials/v1/NCT00414908/results?page=2