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Sponsored by: |
Solvay Pharmaceuticals |
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Information provided by: | Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00623025 |
The study investigates the effect of pancreatic enzymes on steatorrhea in HIV patients.
Condition | Intervention | Phase |
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Steatorrhea |
Drug: Creon 25000 Drug: Placebo |
Phase III |
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: | December 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Creon 25000
6 to 9 capsules Creon 25000 per day
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2: Placebo Comparator |
Drug: Placebo
Placebo
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gregor Eibes | gregor.eibes@solvay.com |
Romania | |
Site 1 | Recruiting |
Bucharest, Romania | |
Site 2 | Recruiting |
Craiova, Romania |
Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
Responsible Party: | Solvay Pharmaceuticals ( Gregor Eibes ) |
Study ID Numbers: | S245.3.125, 2007-005433-11 |
Study First Received: | February 14, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00623025 |
Health Authority: | Romania: National Medicines Agency |
HIV steatorrhea |
Metabolic Diseases Digestive System Diseases Gastrointestinal Diseases HIV Infections Acquired Immunodeficiency Syndrome Malabsorption Syndromes |
Metabolic disorder Intestinal Diseases Pancrelipase Steatorrhea Pancreatin |
Therapeutic Uses Gastrointestinal Agents Pharmacologic Actions |