Creon in HIV Patients With Steatorrhea

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. Identifier: NCT00623025
Recruitment Status : Terminated (Discontinued prematurely due to low enrollment)
First Posted : February 25, 2008
Last Update Posted : August 1, 2011
Information provided by:

February 14, 2008
February 25, 2008
August 1, 2011
January 2009
August 2009   (Final data collection date for primary outcome measure)
Coefficient of fat absorption (CFA) [ Time Frame: After 2 weeks ]
Same as current
Complete list of historical versions of study NCT00623025 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
Creon in HIV Patients With Steatorrhea
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
The study investigates the effect of pancreatic enzymes on steatorrhea in HIV patients.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Drug: Creon 25000
    6 to 9 capsules Creon 25000 per day
  • Drug: Placebo
    6 to 9 capsules placebo per day
  • Experimental: 1
    Intervention: Drug: Creon 25000
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2009
August 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
2007-005433-11 ( EudraCT Number )
00623025 ( Other Identifier: NCT/NIH )
Not Provided
Not Provided
Suntje Sander, Director Clinical Development, Abbott
Not Provided
Study Director: Suntje Sander, PhD Abbott
July 2011

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