Trials / Completed
CompletedNCT00705978
Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis
A One Week Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study With Creon 40,000 MMS in Subjects With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, Followed by an Open-Label Long-Term Extension
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Abbott Products · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will provide efficacy data for Creon 40,000 in CP subjects as well as long-term safety data. During the long-term treatment with Creon 40,000 nutritional parameters will be assessed and correlated with CFA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pancreatin | Pancreatin with 40000 lipase units per capsule, 2 capsules per main meal (3 main meals) plus 1 capsule per snack (2-3 snacks) |
| DRUG | Placebo | placebo |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2010-05-01
- Completion
- 2010-05-01
- First posted
- 2008-06-27
- Last updated
- 2011-08-18
Locations
11 sites across 1 country: India
Source: ClinicalTrials.gov record NCT00705978. Inclusion in this directory is not an endorsement.