Creon in HIV Patients With Steatorrhea

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00623025
• Date of registration: 14/02/2008
• Prospective Registration: Yes
• Primary sponsor: Abbott
• Public title: Creon in HIV Patients With Steatorrhea
• Scientific 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
• Date of first enrolment: January 2009
• Target sample size: 34
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00623025
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Romania

Contacts

• Name: Suntje Sander, PhD
• Affiliation: Abbott

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Steatorrhea

Intervention(s)

Drug: Creon 25000

Drug: Placebo

Primary Outcome(s)

Coefficient of fat absorption (CFA) [Time Frame: After 2 weeks]

Secondary Outcome(s)

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]

Stool fat excretion [Time Frame: After 2 weeks]

Secondary ID(s)

00623025

2007-005433-11

S245.3.125

Source(s) of Monetary Support

Please refer to primary and secondary sponsors