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Study Evaluating rhIL-11 in Active Crohn's Disease

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NCT00040521

Last updated on December 5, 2018
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FOR MORE INFORMATION
Study Location
Arvada, Colorado, 80002 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Crohn Disease, Inflammatory Bowel Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Documented, signed and dated informed consent to participate in this trial prior to
any study related procedures being performed.

- Men and women age 16 years and over.

- Diagnosis of Crohn's disease for at least 6 months that has been appropriately
documented and confirmed by radiological studies, endoscopy (with histological
examination preferred), or surgical pathology (Patients with a diagnosis of Crohn's
disease for less than 6 months may be included if the diagnosis is confirmed by a
biopsy characteristic of Crohn's disease)

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

Use of the following medications within the specified time period prior to randomization:

- Nonsteroidal anti-inflammatory drugs (NSAIDs; including Cyclooxygenase-2 [COX-2]
inhibitors and >500 mg/day acetylsalicylic acid)

- Codeine-containing compounds

- Corticosteroid enemas

NCT00040521
Pfizer
Completed
Study Evaluating rhIL-11 in Active Crohn's Disease

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Pfizer Clinical Trials Contact Center

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[email protected]

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Study Evaluating rhIL-11 in Active Crohn's Disease
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Orally Administered Recombinant Human Interleukin-11 (rhIL-11) for the Treatment of Patients With Active Crohn's Disease
The purpose of this study is to assess the activity of multiple doses of oral rhIL-11 in patients with active Crohn's disease (Crohn's Disease Activity Index [CDAI] score from 220-400).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
  • Crohn Disease
  • Inflammatory Bowel Disease
Drug: Recombinant Human Interleukin-11 (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.
 
Completed
Not Provided
October 2003
October 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented, signed and dated informed consent to participate in this trial prior to any study related procedures being performed.
  • Men and women age 16 years and over.
  • Diagnosis of Crohn's disease for at least 6 months that has been appropriately documented and confirmed by radiological studies, endoscopy (with histological examination preferred), or surgical pathology (Patients with a diagnosis of Crohn's disease for less than 6 months may be included if the diagnosis is confirmed by a biopsy characteristic of Crohn's disease)

Exclusion Criteria:

Use of the following medications within the specified time period prior to randomization:

  • Nonsteroidal anti-inflammatory drugs (NSAIDs; including Cyclooxygenase-2 [COX-2] inhibitors and >500 mg/day acetylsalicylic acid)
  • Codeine-containing compounds
  • Corticosteroid enemas
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00040521
3067K5-208
B2491021 ( Other Identifier: Pfizer )
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
September 2005

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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