Creon in HIV Patients With Steatorrhea - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00623025

Purpose

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

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

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

Drug Information available for: Pancrelipase Ultrase Pancreatin

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

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 February 12, 2012