Creon in HIV Patients With Steatorrhea

This study has been terminated.

( The study was discontinued prematurely on 10AUG2009 due to low recruitment. )

First Received: February 14, 2008 Last Updated: September 4, 2009 History of Changes

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
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:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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: AIDS

Drug Information available for: Pancrelipase Ultrase Pancreatin

Further study details as provided by Solvay Pharmaceuticals:

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 ]

Study Start Date:	December 2008
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Creon 25000 6 to 9 capsules Creon 25000 per day
2: Placebo Comparator	Drug: Placebo Placebo

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

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Gregor Eibes )
Study ID Numbers:	S245.3.125, 2007-005433-11
Study First Received:	February 14, 2008
Last Updated:	September 4, 2009
ClinicalTrials.gov Identifier:	NCT00623025 History of Changes
Health Authority:	Romania: National Medicines Agency

Keywords provided by Solvay Pharmaceuticals:

HIV
steatorrhea

Additional relevant MeSH terms:

Metabolic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Therapeutic Uses
Gastrointestinal Agents
Malabsorption Syndromes

Intestinal Diseases
Pancrelipase
Pharmacologic Actions
Steatorrhea
Pancreatin

ClinicalTrials.gov processed this record on February 04, 2010