Trial · NCT00510484
Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
NCT00510484, Phase 3, Completed, Solvay Pharmaceuticals; results first posted 2009-07-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis. Trials, record NCT00510484. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00510484
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
- NCT number
- NCT00510484
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 35 participants, actual
- Lead sponsor
- Solvay Pharmaceuticals
- Conditions
- Cystic Fibrosis
- Interventions
- Pancrelipase Delayed Release, Placebo Comparator
- First posted
- 2007-08-02
- Last updated
- 2010-06-03
- Results first posted
- 2009-07-20
- 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 include events started prior to the 1st administration but which worsened after the 1st intake.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Coefficient of Fat Absorption (%) | 5 days | This coefficient is calculated from fat intake and fat excretion : 100\*\[fat intake-fat excretion\]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response. |
| Secondary | Coefficient of Nitrogen Absorption (%) | 5 days | This coefficient is calculated from nitrogen intake and nitrogen excretion : 100\*\[nitrogen intake-nitrogen excretion\]/nitrogen intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response. |
| Secondary | Total Fat Excretion (Grams) | 5 days | Total amount of fat excreted during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response. |
| Secondary | Total Stool Weight (Grams) | 5 days | Total weight of the stools collected during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response. |
| Secondary | Stool Frequency | 5 days | Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response. |
| Secondary | Percentage of Days With no Flatulence. | 5 days | The percentage of days with no flatulence is calculated from the diary during the treatment period: 100\*(number of days with no flatulence/number of days recorded in diary). Higher values indicate a better response. |
| Secondary | Percentage of Days With no Abdominal Pain. | 5 days | The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100\*(number of days with no abdominal pain / number of days recorded in diary). Higher values indicate a better response. |
| Other | Percentage of Days With Formed/Normal Stools. | 5 days | The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100\*(number of days with formed/normal stools/number of days with any stool). Higher values indicate a better response. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Coefficient of Fat Absorption (%) | 5 days | The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement. | Percentage | MEAN |
| SECONDARY | Coefficient of Nitrogen Absorption (%) | 5 days | The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement. | Percentage | MEAN |
| SECONDARY | Total Fat Excretion (Grams) | 5 days | The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement. | Grams | MEAN |
| SECONDARY | Total Stool Weight (Grams) | 5 days | The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement. | Grams | MEAN |
| SECONDARY | Stool Frequency | 5 days | The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement. | Number per day | MEAN |
| OTHER_PRE_SPECIFIED | Percentage of Days With Formed/Normal Stools. | 5 days | The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement. | Percentage of days | MEAN |
| SECONDARY | Percentage of Days With no Flatulence. | 5 days | The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement. | Percentage of days | MEAN |
| SECONDARY | Percentage of Days With no Abdominal Pain. | 5 days | The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement. | Percentage of days | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Coefficient of Fat Absorption (%) | Pancrelipase | 88.62 | Standard Deviation 6.62 | Percentage | |
| Coefficient of Fat Absorption (%) | Placebo | 49.78 | Standard Deviation 18.33 | Percentage | |
| Coefficient of Nitrogen Absorption (%) | Pancrelipase | 85.06 | Standard Deviation 6.38 | Percentage | |
| Coefficient of Nitrogen Absorption (%) | Placebo | 49.99 | Standard Deviation 17.14 | Percentage | |
| Total Fat Excretion (Grams) | Pancrelipase | 57.7 | Standard Deviation 46.1 | Grams | |
| Total Fat Excretion (Grams) | Placebo | 243.2 | Standard Deviation 112.7 | Grams | |
| Total Stool Weight (Grams) | Pancrelipase | 630.1 | Standard Deviation 306.9 | Grams | |
| Total Stool Weight (Grams) | Placebo | 1582.5 | Standard Deviation 664.5 | Grams | |
| Stool Frequency | Pancrelipase | 1.75 | Standard Deviation 0.81 | Number per day | |
| Stool Frequency | Placebo | 2.88 | Standard Deviation 1.18 | Number per day |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Placebo/Pancrelipase | 16 | |
| Period 1 | STARTED | Pancrelipase/Placebo | 16 | |
| Period 1 | COMPLETED | Placebo/Pancrelipase | 16 | |
| Period 1 | COMPLETED | Pancrelipase/Placebo | 16 | |
| Period 1 | NOT COMPLETED | Placebo/Pancrelipase | 0 | |
| Period 1 | NOT COMPLETED | Pancrelipase/Placebo | 0 | |
| Wash-out Period | STARTED | Placebo/Pancrelipase | 16 | |
| Wash-out Period | STARTED | Pancrelipase/Placebo | 16 | |
| Wash-out Period | COMPLETED | Placebo/Pancrelipase | 16 | |
| Wash-out Period | COMPLETED | Pancrelipase/Placebo | 15 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events14
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 | Faeces abnormal | Gastrointestinal disorders | Pancrelipase | 1 | 32 | |
| other | Faeces abnormal | Gastrointestinal disorders | Placebo | 6 | 31 | |
| other | Flatulence, Bloating and Distension | Gastrointestinal disorders | Pancrelipase | 3 | 32 | |
| other | Flatulence, Bloating and Distension | Gastrointestinal disorders | Placebo | 8 | 31 | |
| other | Gastrointestinal and abdominal pain (Excl oral and throat) | Gastrointestinal disorders | Pancrelipase | 3 | 32 | |
| other | Gastrointestinal and abdominal pain (Excl oral and throat) | Gastrointestinal disorders | Placebo | 10 | 31 | |
| other | Physical Examination Procedures | Investigations | Pancrelipase | 1 | 32 | |
| other | Physical Examination Procedures | Investigations | Placebo | 2 | 31 | |
| other | Headaches NEC | Nervous system disorders | Pancrelipase | 2 | 32 | |
| other | Headaches NEC | Nervous system disorders | Placebo | 7 | 31 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pancrelipase | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Pancrelipase | 14 | 32 |
| Total, other adverse events | Placebo | 20 | 31 |
| Total, serious adverse events | Pancrelipase | 0 | 32 |
| Total, serious adverse events | Placebo | 0 | 31 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19815466 | RESULT |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pancrelipase vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT00510484
GET https://conductscience.org/api/trials/v1/NCT00510484/registered