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Creon in HIV Patients With Steatorrhea

This study has been terminated.
(Discontinued prematurely due to low enrollment)
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00623025
First received: February 14, 2008
Last updated: July 28, 2011
Last verified: July 2011
History of Changes

February 14, 2008
July 28, 2011
January 2009
August 2009   (final data collection date for primary outcome measure)
Coefficient of fat absorption (CFA) [ Time Frame: After 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00623025 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Steatorrhea
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
34
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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Romania
 
NCT00623025
S245.3.125, 2007-005433-11, 00623025
No
Suntje Sander, Director Clinical Development, Abbott
Abbott
Not Provided
Study Director: Suntje Sander, PhD Abbott
Abbott
July 2011

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