Creon in HIV Patients With Steatorrhea - Tabular View

Tracking Information

First Received Date ^ICMJE

February 14, 2008

Last Updated Date

September 4, 2009

Start Date ^ICMJE

December 2008

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

coefficient of fat absorption (CFA) [ Time Frame: after 2 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00623025 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Creon in HIV Patients With Steatorrhea

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Steatorrhea

Intervention ^ICMJE

Drug: Creon 25000
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

August 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Romania

Administrative Information

NCT ID ^ICMJE

NCT00623025

Responsible Party

Gregor Eibes, Solvay Pharmaceuticals

Study ID Numbers ^ICMJE

S245.3.125, 2007-005433-11

Study Sponsor ^ICMJE

Solvay Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

Information Provided By

Solvay Pharmaceuticals

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP