Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis | NCT00038922

Studies
Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis

NCT00038922

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Terminated

Last Update Posted

May 18, 2006Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Ulcerative Colitis
Inflammatory Bowel Disease

Interventions

rhIL-11

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

Status Module

Record Verification Date

May 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 5, 2002

First Submission Date that Met QC Criteria

Jun 6, 2002

First Posted Date

Jun 7, 2002Estimated

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

May 17, 2006

Last Update Posted Date

May 18, 2006Estimated

Description Module

Brief Summary

To explore the safety of orally delivered rhIL-11 in patients with mild to moderate left-sided ulcerative colitis.

To explore the effects of orally administered rhIL-11 on pharmacogenomics in blood samples and in colonic biopsy tissue samples.

Detailed Description

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 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
rhIL-11	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Documented, signed informed consent to participate in this study
Age greater than or equal to 18 years
Documented diagnosis of ulcerative colitis by standard clinical criteria, including endoscopy (either flexible sigmoidoscopy or colonoscopy, sufficient to define the proximal limit of disease) with biopsy

Exclusion Criteria:

Crohn's disease
Ulcerative proctitis
Ulcerative colitis extending beyond the splenic flexure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor, MD	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative
D015212	Inflammatory Bowel Diseases
D014456	Ulcer
D003092	Colitis

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D003108	Colonic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided