search
Back to results

Safety of Celecoxib in Patients With Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Celebrex
placebo
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Greater than 18 years of age or less than 70 years of age Confirmed diagnosis of Crohn's disease Inactive disease (CDAI scores at baseline <150) or active disease (CDAI scores at baseline <200). Exclusion Criteria: Pregnant, nursing mothers and women of childbearing potential who are not using reliable contraception (i.e.: oral contraceptive pill [OCP], intrauterine device [IUD], Norplant) Enrolled in any other study involving non-steroidal anti-inflammatory drug (NSAID) medications NSAID use at time of study Baseline moderate to severe Crohn's disease activity (CDAI > 200) Current treatment of less than 6 months with mercaptopurine (6 MP) or immuran. Treatment with current Crohn's medication for a period of less than 3 months Surgery for Crohn's disease (within 1 month) Known sensitivity to celecoxib, NSAIDs, or sulfonamides History of gastritis, gastrointestinal bleeding, or peptic ulcer disease Advanced kidney disease Severe hepatic impairment Subjects currently taking angiotensin-converting enzyme (ACE) inhibitors, furosemide, fluconazole, lithium, corticosteroids, and warfarin

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    A Placebo or Celebrex

    B Placebo or Celebrex

    Arm Description

    either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks

    either placebo PO BID for the last eight weeks or Celebrex 200 mg PO BID for the last eight weeks

    Outcomes

    Primary Outcome Measures

    Change in Crohn's Disease Activity Index (CDAI) Scores in Response to Treatment
    Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment

    Secondary Outcome Measures

    Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scores in Response to Treatment
    No results or publication, data destroyed due to age of study.

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    July 28, 2016
    Sponsor
    University of Pittsburgh
    Collaborators
    Shadyside Hospital Foundation, Pfizer
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00177866
    Brief Title
    Safety of Celecoxib in Patients With Crohn's Disease
    Official Title
    The Safety of Celecoxib (Celebrex) in Patients With Crohn's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Terminated
    Why Stopped
    We were unable to get additional funding to complete study.
    Study Start Date
    December 2003 (undefined)
    Primary Completion Date
    June 2010 (Actual)
    Study Completion Date
    June 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Pittsburgh
    Collaborators
    Shadyside Hospital Foundation, Pfizer

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators will select 60 people who are 18-70 years of age with Crohn's disease and randomly assign them to receive an 8-week trial of celecoxib and an 8-week trial of a placebo. There will be a 1-week interval or "wash-out" between trials when the participant does not take any study medication. The investigators will monitor the participants for 18 weeks after they start the medication and observe their Crohn's disease activity, assessing for flare-ups or exacerbations in the disease and other possible side effects of celecoxib. Based on these observations, a determination will be made by the investigators as to the safety of celecoxib. If celecoxib is found to be safe, then it may provide physicians with a medication that they can prescribe for people who have Crohn's disease and experience chronic pain from arthritis and arthralgia.
    Detailed Description
    Please refer to brief summary (above).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Crohn's Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A Placebo or Celebrex
    Arm Type
    Active Comparator
    Arm Description
    either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks
    Arm Title
    B Placebo or Celebrex
    Arm Type
    Placebo Comparator
    Arm Description
    either placebo PO BID for the last eight weeks or Celebrex 200 mg PO BID for the last eight weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Celebrex
    Other Intervention Name(s)
    Celecoxib (brand name)
    Intervention Description
    Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week "washout period" then placebo PO BID for the remaining 8 weeks - or - placebo PO BID for the first 8 weeks, followed by a 1 week "washout period" then Celebrex 200 mg PO BID for the remaining 8 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    placebo PO BID for either the first eight weeks or the last eight weeks of the study.
    Primary Outcome Measure Information:
    Title
    Change in Crohn's Disease Activity Index (CDAI) Scores in Response to Treatment
    Description
    Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment
    Time Frame
    completion of all study participants
    Secondary Outcome Measure Information:
    Title
    Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scores in Response to Treatment
    Description
    No results or publication, data destroyed due to age of study.
    Time Frame
    completion of all study participants

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Greater than 18 years of age or less than 70 years of age Confirmed diagnosis of Crohn's disease Inactive disease (CDAI scores at baseline <150) or active disease (CDAI scores at baseline <200). Exclusion Criteria: Pregnant, nursing mothers and women of childbearing potential who are not using reliable contraception (i.e.: oral contraceptive pill [OCP], intrauterine device [IUD], Norplant) Enrolled in any other study involving non-steroidal anti-inflammatory drug (NSAID) medications NSAID use at time of study Baseline moderate to severe Crohn's disease activity (CDAI > 200) Current treatment of less than 6 months with mercaptopurine (6 MP) or immuran. Treatment with current Crohn's medication for a period of less than 3 months Surgery for Crohn's disease (within 1 month) Known sensitivity to celecoxib, NSAIDs, or sulfonamides History of gastritis, gastrointestinal bleeding, or peptic ulcer disease Advanced kidney disease Severe hepatic impairment Subjects currently taking angiotensin-converting enzyme (ACE) inhibitors, furosemide, fluconazole, lithium, corticosteroids, and warfarin
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    George L Arnold, MD
    Organizational Affiliation
    University of Pittsburgh
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Safety of Celecoxib in Patients With Crohn's Disease

    We'll reach out to this number within 24 hrs