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| Sponsored by: |
Solvay Pharmaceuticals |
| Information provided by: | Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00623025 |
Purpose
The study investigates the effect of pancreatic enzymes on steatorrhea in HIV patients.
| Condition | Intervention | Phase |
|
Steatorrhea |
Drug: Creon 25000 Drug: Placebo |
Phase III |
| MedlinePlus related topics: | AIDS |
| ChemIDplus related topics: | Pancrelipase Ultrase Pancreatin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Double-Blind, Cross-Over, Randomized, Placebo-Controlled, Multi-Center Study to Investigate the Effect of Creon®25 000 on the Coefficient of Fat Absorption of HIV-Infected Patients |
| Estimated Enrollment: | 34 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental |
Drug: Creon 25000
6 to 9 capsules Creon 25000 per day
|
| 2: Placebo Comparator |
Drug: Placebo
Placebo
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Gregor Eibes | gregor.eibes@solvay.com |
| Romania | |||||
| Site 1 | Not yet recruiting | ||||
| Bucharest, Romania | |||||
| Site 2 | Not yet recruiting | ||||
| Craiova, Romania | |||||
| Solvay Pharmaceuticals |
| Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
More Information
| Responsible Party: | Solvay Pharmaceuticals ( Gregor Eibes ) |
| Study ID Numbers: | S245.3.125, 2007-005433-11 |
| First Received: | February 14, 2008 |
| Last Updated: | June 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00623025 |
| Health Authority: | Romania: National Medicines Agency |
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