Phase II Placebo-Controlled Study of 4-Aminosalicylic Aci... | NCT00004810

Studies
Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis

NCT00004810

Sponsor

National Center for Research Resources (NCRR)

Status

Completed

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Phase

Phase 2

Conditions

Ulcerative Colitis

Interventions

-aminosalicylic acid

Countries

Not provided

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
UVT-12012

Status Module

Record Verification Date

Dec 2001

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1996

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 24, 2000

First Submission Date that Met QC Criteria

Feb 24, 2000

First Posted Date

Feb 25, 2000Estimated

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

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Name	Class
University of Vermont	OTHER

Description Module

Brief Summary

OBJECTIVES:

I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis.

Detailed Description

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by extent of disease.

Patients are randomly assigned to oral 4-aminosalicylic acid (4-ASA) or placebo administered daily for 6 weeks. Optional 4-ASA is available to all patients for up to 1 year.

Concurrent therapy with low-dose sulfasalazine, prednisone, or equivalent is allowed.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
-aminosalicylic acid	Drug

Eligibility Module

Eligibility Criteria

PROTOCOL ENTRY CRITERIA:

Mildly to moderately severe ulcerative colitis
Patient age: 18 to 80

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

Name	Affiliation	Role
Warren L. Beeken	University of Vermont	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9052519	Background	Beeken W, Howard D, Bigelow J, Trainer T, Roy M, Thayer W, Wild G. Controlled trial of 4-ASA in ulcerative colitis. Dig Dis Sci. 1997 Feb;42(2):354-8. doi: 10.1023/a:1018874120749.

ID	Term
D003093	Colitis, Ulcerative
D005767	Gastrointestinal Diseases
D035583	Rare Diseases

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D004066	Digestive System Diseases
D015212	Inflammatory Bowel Diseases

ID	Term
D062366	para-Aminobenzoates
D062365	Aminobenzoates
D001565	Benzoates
D000146	Acids, Carbocyclic