Creon in HIV Patients With Steatorrhea | NCT00623025

Studies
Creon in HIV Patients With Steatorrhea

NCT00623025

Sponsor

Abbott

Status

Terminated

Last Update Posted

Aug 1, 2011Estimated

Enrollment

34Actual

Phase

Phase 3

Conditions

Steatorrhea

Interventions

Creon 25000
Placebo

Countries

Romania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007-005433-11	EudraCT Number
00623025	Other Identifier	NCT/NIH

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Discontinued prematurely due to low enrollment

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Feb 14, 2008

First Submission Date that Met QC Criteria

Feb 14, 2008

First Posted Date

Feb 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2011

Last Update Posted Date

Aug 1, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Creon 25000
2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Creon 25000	Drug	6 to 9 capsules Creon 25000 per day	1
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Suntje Sander, PhD	Abbott	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site Reference ID/Investigator# 59364		Bucharest		021105	Romania
Site Reference ID/Investigator# 59363

Condition Browse Module

MeSH Terms

ID	Term
D045602	Steatorrhea

Ancestor Terms

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided