Trial · NCT00662675
A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency
NCT00662675, Phase 3, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2010-03-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency. Trials, record NCT00662675. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00662675
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency
- NCT number
- NCT00662675
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 40 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Exocrine Pancreatic Insufficiency, Steatorrhea, Malabsorption Syndromes, Cystic Fibrosis
- Interventions
- Pancrease MT 10.5, or MT 21, Placebo for Pancrease MT 10.5 or MT 21
- First posted
- 2008-04-21
- Last updated
- 2014-05-09
- Results first posted
- 2010-03-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Coefficient of Fat Absorption (COA-fat Percent) | 72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase. | Change in the coefficient of fat absorption (percent COA-fat) from the 72-hour inpatient period in the open-label phase to the 72-hour period inpatient period in the double-blind (withdrawal) phase. |
| Secondary | Change in Percent COA-Protein (Nitrogen) | 72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase. | The change in percent COA-protein from the stool collection period in double-blind phase to open-label phase |
| Secondary | Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase | Entire 7 days double-blind phase | Percent of patients reporting nausea, vomiting, bloating, diarrhea, oily/greasy stools, and abdominal pain signs and symptoms reported as Adverse events during the double-blind phase. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the Coefficient of Fat Absorption (COA-fat Percent) | 72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase. | Intent-to-Treat (ITT) | percentage COA-fat | MEAN |
| SECONDARY | Change in Percent COA-Protein (Nitrogen) | 72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase. | ITT | percentage COA-protein | MEAN |
| SECONDARY | Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase | Entire 7 days double-blind phase | ITT | Percent of participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Change in the Coefficient of Fat Absorption (COA-fat Percent) | Placebo | -34.1 | Standard Deviation 23.03 | percentage COA-fat | |
| Change in the Coefficient of Fat Absorption (COA-fat Percent) | PANCREASE MT | -1.5 | Standard Deviation 5.88 | percentage COA-fat | |
| Change in Percent COA-Protein (Nitrogen) | Placebo | -26.5 | Standard Deviation 15.3 | percentage COA-protein | |
| Change in Percent COA-Protein (Nitrogen) | PANCREASE MT | 1.3 | Standard Deviation 4.71 | percentage COA-protein | |
| Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase | Placebo | % of subjects with at least one EPI symptoms | 55 | Percent of participants | |
| Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase | PANCREASE MT | % of subjects with at least one EPI symptoms | 20 | Percent of participants | |
| Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase | Placebo | % of subjects with Abdominal pain | 30 | Percent of participants | |
| Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase | PANCREASE MT | % of subjects with Abdominal pain | 15 | Percent of participants | |
| Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase | Placebo | % of subjects with Bloating | 15 | Percent of participants | |
| Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase | PANCREASE MT | % of subjects with Bloating | 5 | Percent of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | STARTED | PANCREASE MT | 20 | |
| Overall Study | COMPLETED | Placebo | 20 | |
| Overall Study | COMPLETED | PANCREASE MT | 20 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | PANCREASE MT | 0 |
Source ClinicalTrials.gov
Adverse events46
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 | Abdominal pain | Gastrointestinal disorders | Placebo | 3 | 20 | |
| other | Abdominal pain | Gastrointestinal disorders | PANCREASE MT | 2 | 20 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 3 | 20 | |
| other | Abdominal pain upper | Gastrointestinal disorders | PANCREASE MT | 1 | 20 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 4 | 20 | |
| other | Diarrhoea | Gastrointestinal disorders | PANCREASE MT | 0 | 20 | |
| other | Flatulence | Gastrointestinal disorders | Placebo | 3 | 20 | |
| other | Flatulence | Gastrointestinal disorders | PANCREASE MT | 1 | 20 | |
| other | Abnormal faeces | Gastrointestinal disorders | Placebo | 3 | 20 | |
| other | Abnormal faeces | Gastrointestinal disorders | PANCREASE MT | 0 | 20 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | PANCREASE MT | ||
| Total, other adverse events | Placebo | 12 | 20 |
| Total, other adverse events | PANCREASE MT | 8 | 20 |
| Total, serious adverse events | Placebo | 0 | 20 |
| Total, serious adverse events | PANCREASE MT | 0 | 20 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| PANCREASE MT 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/NCT00662675
GET https://conductscience.org/api/trials/v1/NCT00662675/events?page=2