Creon in HIV Patients With Steatorrhea

This study has been terminated.
(Discontinued prematurely due to low enrollment)
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00623025
First received: February 14, 2008
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Steatorrhea
Drug: Creon 25000
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Coefficient of fat absorption (CFA) [ Time Frame: After 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stool fat excretion [ Time Frame: After 2 weeks ] [ Designated as safety issue: No ]
  • Normalization (yes, no) of stool fat excretion, i.e. < 7 g/day [ Time Frame: After 2 weeks ] [ Designated as safety issue: No ]
  • Response (yes, no) with respect to stool fat excretion, i.e. improvement in stool fat excretion as compared to baseline [ Time Frame: After 2 weeks ] [ Designated as safety issue: No ]
  • Stool weight [ Time Frame: After 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: January 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Creon 25000
6 to 9 capsules Creon 25000 per day
Placebo Comparator: 2 Drug: Placebo
6 to 9 capsules placebo per day

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623025

Locations
Romania
Site Reference ID/Investigator# 59364
Bucharest, Romania, 021105
Site Reference ID/Investigator# 59363
Craiova, Romania, 200515
Sponsors and Collaborators
Abbott
Investigators
Study Director: Suntje Sander, PhD Abbott
  More Information

No publications provided

Responsible Party: Suntje Sander, Director Clinical Development, Abbott
ClinicalTrials.gov Identifier: NCT00623025     History of Changes
Other Study ID Numbers: S245.3.125, 2007-005433-11, 00623025
Study First Received: February 14, 2008
Last Updated: July 28, 2011
Health Authority: Romania: National Medicines Agency

Keywords provided by Abbott:
HIV
Steatorrhea

Additional relevant MeSH terms:
Steatorrhea
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014