Creon in HIV Patients With Steatorrhea

Phase 3

Terminated

• Conditions: Steatorrhea
• Interventions: Drug: Placebo; Drug: Creon 25000

• Registration Number: NCT00623025
• Lead Sponsor: Abbott

Brief Summary

The study investigates the effect of pancreatic enzymes on steatorrhea in HIV patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-14
• Study First Posted: 2008-02-25
• Study Start: 2009-01
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-28
• Last Update Posted: 2011-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Creon 25000	-

Primary Outcome Measures

Name	Time	Method
Coefficient of fat absorption (CFA)	After 2 weeks

Secondary Outcome Measures

Name	Time	Method
Stool fat excretion	After 2 weeks
Normalization (yes, no) of stool fat excretion, i.e. < 7 g/day	After 2 weeks
Response (yes, no) with respect to stool fat excretion, i.e. improvement in stool fat excretion as compared to baseline	After 2 weeks
Stool weight	After 2 weeks

Trial Locations

Locations (2)

Site Reference ID/Investigator# 59363; 🇷🇴 Craiova, Romania

Site Reference ID/Investigator# 59364; 🇷🇴 Bucharest, Romania