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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
History of Changes
  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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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
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
 Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013