Creon in HIV Patients With Steatorrhea

Steatorrhea Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00623025
• Other study ID #: S245.3.125
• Secondary ID: 2007-005433-1100
• Status: Terminated
• Phase: Phase 3
• First received: February 14, 2008
• Last updated: July 28, 2011
• Start date: January 2009
• Est. completion date: August 2009

Study information

• Verified date: July 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Steatorrhea

Intervention

Drug:
• Creon 25000
6 to 9 capsules Creon 25000 per day
• Placebo
6 to 9 capsules placebo per day

Locations

Country	Name	City	State
Romania	Site Reference ID/Investigator# 59364	Bucharest
Romania	Site Reference ID/Investigator# 59363	Craiova

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coefficient of fat absorption (CFA)		After 2 weeks	No
Secondary	Stool fat excretion		After 2 weeks	No
Secondary	Normalization (yes, no) of stool fat excretion, i.e. < 7 g/day		After 2 weeks	No
Secondary	Response (yes, no) with respect to stool fat excretion, i.e. improvement in stool fat excretion as compared to baseline		After 2 weeks	No
Secondary	Stool weight		After 2 weeks	No