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Creon in HIV Patients With Steatorrhea

This study has been terminated.
(Discontinued prematurely due to low enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00623025
First Posted: February 25, 2008
Last Update Posted: August 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Stool fat excretion [ Time Frame: After 2 weeks ]
  • Normalization (yes, no) of stool fat excretion, i.e. < 7 g/day [ Time Frame: After 2 weeks ]
  • 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 ]
  • Stool weight [ Time Frame: After 2 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( EudraCT Number )
00623025 ( Other Identifier: NCT/NIH )
First Submitted: February 14, 2008
First Posted: February 25, 2008
Last Update Posted: August 1, 2011
Last Verified: July 2011

Keywords provided by Abbott:
HIV
Steatorrhea

Additional relevant MeSH terms:
Steatorrhea
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents