Creon in HIV Patients With Steatorrhea

Abbott

Status and phase: Terminated; Phase 3

Conditions: Steatorrhea

Treatments: Drug: Creon 25000; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00623025

2007-005433-11 (EudraCT Number)

00623025 (Other Identifier)

S245.3.125

Details and patient eligibility

About

The study investigates the effect of pancreatic enzymes on steatorrhea in HIV patients.

Enrollment: 34 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Creon 25000

2

Placebo Comparator group

Treatment:

Drug: Placebo