Study Stopped
Discontinued prematurely due to low enrollment
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
3 other identifiers
interventional
34
1 country
2
Brief Summary
The study investigates the effect of pancreatic enzymes on steatorrhea in HIV patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2009
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2008
CompletedFirst Posted
Study publicly available on registry
February 25, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedAugust 1, 2011
July 1, 2011
7 months
February 14, 2008
July 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Coefficient of fat absorption (CFA)
After 2 weeks
Secondary Outcomes (4)
Stool fat excretion
After 2 weeks
Normalization (yes, no) of stool fat excretion, i.e. < 7 g/day
After 2 weeks
Response (yes, no) with respect to stool fat excretion, i.e. improvement in stool fat excretion as compared to baseline
After 2 weeks
Stool weight
After 2 weeks
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (2)
Site Reference ID/Investigator# 59364
Bucharest, 021105, Romania
Site Reference ID/Investigator# 59363
Craiova, 200515, Romania
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Suntje Sander, PhD
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 14, 2008
First Posted
February 25, 2008
Study Start
January 1, 2009
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
August 1, 2011
Record last verified: 2011-07