Back to resultsCreon in HIV Patients With Steatorrhea
Primary Purpose
Steatorrhea
Status
Terminated
Phase
Phase 3
Locations
Romania
Study Type
Interventional
Intervention
Creon 25000
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Steatorrhea focused on measuring HIV, Steatorrhea
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
Sites / Locations
- Site Reference ID/Investigator# 59364
- Site Reference ID/Investigator# 59363
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Coefficient of fat absorption (CFA)
Secondary Outcome Measures
Stool fat excretion
Normalization (yes, no) of stool fat excretion, i.e. < 7 g/day
Response (yes, no) with respect to stool fat excretion, i.e. improvement in stool fat excretion as compared to baseline
Stool weight
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00623025
Brief Title
Creon in HIV Patients With Steatorrhea
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Why Stopped
Discontinued prematurely due to low enrollment
Study Start Date
January 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study investigates the effect of pancreatic enzymes on steatorrhea in HIV patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Steatorrhea
Keywords
HIV, Steatorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Creon 25000
Intervention Description
6 to 9 capsules Creon 25000 per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
6 to 9 capsules placebo per day
Primary Outcome Measure Information:
Title
Coefficient of fat absorption (CFA)
Time Frame
After 2 weeks
Secondary Outcome Measure Information:
Title
Stool fat excretion
Time Frame
After 2 weeks
Title
Normalization (yes, no) of stool fat excretion, i.e. < 7 g/day
Time Frame
After 2 weeks
Title
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
Title
Stool weight
Time Frame
After 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suntje Sander, PhD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 59364
City
Bucharest
ZIP/Postal Code
021105
Country
Romania
Facility Name
Site Reference ID/Investigator# 59363
City
Craiova
ZIP/Postal Code
200515
Country
Romania
12. IPD Sharing Statement
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Creon in HIV Patients With Steatorrhea
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