Creon in HIV Patients With Steatorrhea
Information source: Solvay Pharmaceuticals
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Steatorrhea
Intervention: Creon 25000 (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
Overall contact:
Gregor Eibes, Email: gregor.eibes@solvay.com
Summary
The study investigates the effect of pancreatic enzymes on steatorrhea in HIV patients.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: coefficient of fat absorption (CFA)
Secondary outcome: Stool fat excretionNormalization (yes, no) of stool fat excretion, i.e. < 7 g/day Response (yes, no) with respect to stool fat excretion, i.e. improvement in stool fat excretion as compared to baseline Stool weight
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- HIV positive patients with clinically stable disease (Karnofsky Performance Status >
40);
- Steatocrit > 2 %;
- Females of child-bearing potential must have a negative pregnancy test during prestudy
or the subject must be surgically sterile or be at least 1 year postmenopausal as
judged by the investigator;
- Women of child-bearing potential must be using a medically acceptable method of birth
control throughout the study
Exclusion Criteria:
- Known allergy to pancreatin or any history of abnormal drug reaction;
- Known diagnosis of pancreatic exocrine insufficiency due to e. g. chronic pancreatitis
or cystic fibrosis or pancreatectomy;
- Intake of an experimental drug within four weeks prior to entry into the study;
- Alcohol abuse within the last six months; Suspected non-compliance or
non-cooperation;
- Any other lack of fitness, in the investigator's opinion, to participate in or to
complete the study; Patients with a stool fat excretion <= 7 g/day according to van de
Kamer during the run-in period
Locations and Contacts
Gregor Eibes, Email: gregor.eibes@solvay.com
Site 1, Bucharest, Romania; Recruiting
Site 2, Craiova, Romania; Recruiting
Additional Information
Starting date: December 2008
Ending date: October 2009
Last updated: January 15, 2009
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