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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00623025

Enrollment

Registered

2008-02-25

Start date

2009-01-31

Completion date

2009-08-31

Last updated

2011-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Steatorrhea

Keywords

HIV, Steatorrhea

Brief summary

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

Interventions

DRUGCreon 25000

6 to 9 capsules Creon 25000 per day

DRUGPlacebo

6 to 9 capsules placebo per day

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Coefficient of fat absorption (CFA)	After 2 weeks

Secondary

Measure	Time frame
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

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026