Crohn's DiseasePhase 4NCT00177866
Safety of Celecoxib in Patients With Crohn's Disease
A Phase 4 study testing Celebrex in people with Crohn's Disease, run by University of Pittsburgh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Celebrex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Jun 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
Official title: The Safety of Celecoxib (Celebrex) in Patients With Crohn's Disease
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.
Read the detailed description
Please refer to brief summary (above).
- Conditions
- Crohn's Disease
- Being tested
- Celebrex, placebo
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelebrexDrug
Also called Celecoxib (brand name)
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.
placeboDrug
placebo PO BID for either the first eight weeks or the last eight weeks of the study.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: completion of all study participants
Secondary outcomes (1)
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scores in Response to Treatment
No results or publication, data destroyed due to age of study.
Measured: completion of all study participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: We were unable to get additional funding to complete study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Shadyside Hospital Foundation, Pfizer
- Responsible party
- Sponsor
- Investigators
- George L Arnold, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177866
- Sponsor's protocol ID
- 0312013
- Status last verified
- Jun 2016
- First submitted
- 13 Sep 2005
- Last updated
- 29 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of Celecoxib (Celebrex) in Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT00177866
- Acronym / sponsor ID
- 0312013
- Conditions
- Crohn's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We were unable to get additional funding to complete study.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Shadyside Hospital Foundation, Pfizer
- Study start
- Dec 2003
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 15 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Placebo or Celebrex | Active comparator | Drug: Celebrexeither placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks |
| B Placebo or Celebrex | Placebo comparator | Drug: placeboeither placebo PO BID for the last eight weeks or Celebrex 200 mg PO BID for the last eight weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelebrexAlso: Celecoxib (brand name)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. | Drug | A Placebo or Celebrex |
| placeboplacebo PO BID for either the first eight weeks or the last eight weeks of the study. | Drug | B Placebo or Celebrex |
Primary outcome
Change in Crohn's Disease Activity Index (CDAI) Scores in Response to Treatment
Time frame: completion of all study participants
Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment
1 secondary outcome
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scores in Response to Treatment
Time frame: completion of all study participants
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George L Arnold, MD principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Celebrex in people with Crohn's Disease, run by University of Pittsburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Crohn's Disease Activity Index (CDAI) Scores in Response to Treatment (time frame: completion of all study participants). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2016.