Osteoarthritis of the KneePhase 2NCT00597415
Efficacy of Celecoxib 200mg in Relieving Pain and Walking Dysfunction in Osteoarthritis of the Knee
A Phase 2 study testing celecoxib in people with Osteoarthritis of the Knee, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare the efficacy of celecoxib versus placebo in delaying the onset of pain and improving walking function in subjects with knee Osteoarthritis Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- celecoxib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Mar 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- If female and of childbearing potential, must be using adequate contraception since last menses and will use adequate contraception during the study,
- Diagnosed as having OA of the knee
- Functional Capacity Classification of I-II (FCC)
- If on active analgesic or anti-inflammatory pain medication, must have VAS pain score>=30mm in signal knee related to walking on a flat surface within the previous 48 hours. Subjects who are not taking any pain medication must have a VAS pain score>=40mm in the signal knee
- At baseline visit, must have a history of pain in the signal knee>=40mm when walking on the flat within the previous 48 hours.
- In the Investigator's opinion, the patient requires and is eligible for therapy with an anti-inflammatory analgesic.
- If on an NSAID or analgesic, patient must have completed a washout period prior to baseline assessments that is a minium of five half lives.
- The patient has provided written informed consent before undergoing any study procedures.
Who cannot join
- Diagnosed as having inflammatory arthritis or acute trauma at the index joint.
- Another painful condition that would interfere with his/her ability to walk or to make reasonable assessments of their pain.
- Received an injection of corticosteroid into the signal knee within 3 months; or with a hyaluronan produce in the signal knee within the previous 6 months.
- Requires the use of a cane or other assistive device to complete the walk.
- Known cardiovascular disease which has been symptomatic in the past 12 months
- History of blood clots or is at any increased risk for blood clotting.
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- Asthma or any breathing condition which would preclude walking briskly for 20 consecutive minutes or 40 minutes total.
- Has taken any NSAIDs, COX-2 inhibitors, or any analgesic, with the exception of the rescue acetaminophen, within two days prior to Visit 2
- Active malignancies or any type or a malignancy that has recurred within 5 years before enrollment.
- Diagnosed as having or has been treated for esophageal, gastric, pyloric channel, duodenal ulceration within 90 days
- Active GI disease, a chronic or acute renal or hepatic disorder, or a significant coagulation defect.
- Any chronic illness or laboratory abnormalities considered to be clinically significant.
- Received any investigational medication within 30 days
- Known hypersensitivity to celecoxib, NSAIDs, to sulfonamides
- Use of the following drugs:
- NSAIDs or COX-2 specific inhibitors
- Analgesics except rescue medication within 24 hours of a study visit
- Anticoagulants
- Lithium
- Glucosamine or chondroitin sulfate are excluded unless on stable dose for at least 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Case Medical Center
Beachwood, Ohio, 44122
Nora G Singer, MD
Mary Lesko, CNP
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized, Crossover Pilot Study of the Efficacy of Celecoxib 200 mg QD in Relieving Pain and Walking Dysfunction in Osteoarthritis of the Knee.
The purpose of this study is to compare the efficacy of celecoxib versus placebo in delaying the onset of pain and improving walking function in subjects with knee Osteoarthritis
Read the detailed description
We have developed a walking model that safely and reproducibly induces pain in subjects with knee OA in a manner that permits the comparison of the effect of different therapies on pain control. In a previous study, we demonstrated that a self-paced 20 minute walk followed by a one-hour rest and a second coordinator-paced 20-minute walk was well tolerated and generated moderate to severe pain in all participants within the time frame of the walk. We will now use this model, but with a crossover design to test the efficacy of celecoxib compared to placebo for the control of knee pain and improvement of walking function.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- celecoxib, placebo
- Keywords
- Osteoarthritis, Knee pain
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
Also called Celebrex
celecoxib 200mg
placeboDrug
Also called inactive capsule
placebo
| Study group | Role | What they receive |
|---|---|---|
| A 1 | Placebo comparator | A 1=placebo Receives: Drug: placebo |
| A 2 | Active comparator | A 2=celecoxib Receives: Drug: celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the time to onset of moderate and severe pain. The mean change in time to onset of moderate and sever pain between the first and second walks will be compared using paired t-tests.
Measured: Visits 2 and 3
Secondary outcomes (1)
Secondary endpoints are the distance to onset of moderate to sever pain the the percent responders in each group. Thirty subjects will be studied in this randomized, placebo-controlled, double-blind crossover study.
Measured: Visits 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startDec 2004
- Primary completionFeb 2008 (estimated)
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Nora G Singer, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597415
- Sponsor's protocol ID
- Pfizer walking model
- Other IDs
- UH IRB 06-04-41
- Status last verified
- Dec 2007
- First submitted
- 9 Jan 2008
- Last updated
- 18 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized, Crossover Pilot Study of the Efficacy of Celecoxib 200 mg QD in Relieving Pain and Walking Dysfunction in Osteoarthritis of the Knee.
- ClinicalTrials.gov ID
- NCT00597415
- Acronym / sponsor ID
- Pfizer walking model
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis, Knee pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Feb 2008 (estimated)
- Study completion
- Mar 2008 (estimated)
- First posted
- 18 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy of celecoxib versus placebo in delaying the onset of pain and improving walking function in subjects with knee Osteoarthritis
Detailed description
We have developed a walking model that safely and reproducibly induces pain in subjects with knee OA in a manner that permits the comparison of the effect of different therapies on pain control. In a previous study, we demonstrated that a self-paced 20 minute walk followed by a one-hour rest and a second coordinator-paced 20-minute walk was well tolerated and generated moderate to severe pain in all participants within the time frame of the walk. We will now use this model, but with a crossover design to test the efficacy of celecoxib compared to placebo for the control of knee pain and improvement of walking function.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A 1 | Placebo comparator | Drug: placeboA 1=placebo |
| A 2 | Active comparator | Drug: celecoxibA 2=celecoxib |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- If female and of childbearing potential, must be using adequate contraception since last menses and will use adequate contraception during the study,
- Diagnosed as having OA of the knee
- Functional Capacity Classification of I-II (FCC)
- If on active analgesic or anti-inflammatory pain medication, must have VAS pain score>=30mm in signal knee related to walking on a flat surface within the previous 48 hours. Subjects who are not taking any pain medication must have a VAS pain score>=40mm in the signal knee
- At baseline visit, must have a history of pain in the signal knee>=40mm when walking on the flat within the previous 48 hours.
Key exclusion criteria (20 listed)
- Diagnosed as having inflammatory arthritis or acute trauma at the index joint.
- Another painful condition that would interfere with his/her ability to walk or to make reasonable assessments of their pain.
- Received an injection of corticosteroid into the signal knee within 3 months; or with a hyaluronan produce in the signal knee within the previous 6 months.
- Requires the use of a cane or other assistive device to complete the walk.
- Known cardiovascular disease which has been symptomatic in the past 12 months
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 |
|---|---|---|
| celecoxibAlso: Celebrexcelecoxib 200mg | Drug | A 2 |
| placeboAlso: inactive capsuleplacebo | Drug | A 1 |
Primary outcome
The primary endpoint is the time to onset of moderate and severe pain. The mean change in time to onset of moderate and sever pain between the first and second walks will be compared using paired t-tests.
Time frame: Visits 2 and 3
1 secondary outcome
Secondary endpoints are the distance to onset of moderate to sever pain the the percent responders in each group. Thirty subjects will be studied in this randomized, placebo-controlled, double-blind crossover study.
Time frame: Visits 2 and 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2008.
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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.
Nora G Singer, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing celecoxib in people with Osteoarthritis of the Knee, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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 8 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 18 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Wallette, CMA, CCRC (216-591-1443 ext. 15, michelle.wallette@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the time to onset of moderate and severe pain. The mean change in time to onset of moderate and sever pain between the first and second walks will be compared using paired t-tests. (time frame: Visits 2 and 3). 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 18 Jan 2008.