Safety of Celecoxib in Patients With Crohn's Disease

NCT00177866 | Terminated Phase 4 Results DMC

• 1 other identifier: 0312013
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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

  completion of all study participants

Secondary Outcomes (1)

• Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scores in Response to Treatment

  completion of all study participants

Study Arms (2)

A Placebo or Celebrex

ACTIVE COMPARATOR

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

Drug: Celebrex

B Placebo or Celebrex

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Celebrex DRUG

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.

Also known as: Celecoxib (brand name)

A Placebo or Celebrex

placebo DRUG

placebo PO BID for either the first eight weeks or the last eight weeks of the study.

B Placebo or Celebrex

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Shadyside Hospital Foundation: collaborator
• Pfizer: collaborator

MeSH Terms

Conditions

Crohn Disease

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: George Arnold, MD
• Organization: University of Pittseburgh

Arnoldgl@upmc.edu

412 621-2334

Study Officials

• George L Arnold, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: December 1, 2003
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 29, 2016
• Results First Posted: July 15, 2016

Record last verified: 2016-06