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Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis

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NCT00038922

Last updated on October 4, 2018
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Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis, Inflammatory Bowel Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Crohn's disease

- Ulcerative proctitis

- Ulcerative colitis extending beyond the splenic flexure

NCT00038922
Pfizer
Terminated
Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis

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Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Safety and Exploratory Pharmacogenomic Study of Orally Administered Recombinant Human Interleukin Eleven (rhIL-11) in Patients With Mild to Moderate Left-Sided Ulcerative Colitis

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.
Not Provided
Interventional
Phase 1
Primary Purpose: Treatment
  • Ulcerative Colitis
  • Inflammatory Bowel Disease
Drug: rhIL-11
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
Not Provided
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00038922
3067K5-114
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
May 2006

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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