Creon in HIV Patients With Steatorrhea

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

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

Study Overview

• Status: Terminated
• Conditions: Steatorrhea
• Intervention / Treatment: Drug: Creon 25000; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 3

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania, 021105
    • Site Reference ID/Investigator# 59364
  • Craiova, Romania, 200515
    • Site Reference ID/Investigator# 59363

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2	Drug: Placebo; 6 to 9 capsules placebo per day
EXPERIMENTAL: 1	Drug: Creon 25000; 6 to 9 capsules Creon 25000 per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Coefficient of fat absorption (CFA)	After 2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Suntje Sander, PhD, Abbott

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): August 1, 2009
• Study Completion (ACTUAL): August 1, 2009

Study Registration Dates

• First Submitted: February 14, 2008
• First Submitted That Met QC Criteria: February 14, 2008
• First Posted (ESTIMATE): February 25, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 1, 2011
• Last Update Submitted That Met QC Criteria: July 28, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: HIV; Steatorrhea
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Steatorrhea
• Other Study ID Numbers: S245.3.125; 2007-005433-11 (EUDRACT_NUMBER); 00623025 (OTHER: NCT/NIH)