Knee OsteoarthritisPhase 4NCT00194090
Efficacy of Celecoxib vs Placebo to Prevent Pain in a Paced Walk
A Phase 4 study testing celecoxib in people with Knee Osteoarthritis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
A paced 20-minute walk is a reproducible model for acute pain in knee osteoarthritis Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- celecoxib
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to 1 Sep 2005
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee osteoarthritis by ACR clinical criteria Pain of at least 40 mm by VAS at baseline
- -
Who cannot join
- Non-pregant, non-lactating Able to stop active arthritis medication for washout Cardiovascular risk factors Abnormal EKG -
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland
Cleveland, Ohio, 44106
About this study
Official title: A Double-blind, Placebo-controlled, Crossover Pilot Study of the Efficacy of Celecoxib 200 mg qd in Relieving Pain and Walking Dysfunction in Osteoarthritis of the Knee
A paced 20-minute walk is a reproducible model for acute pain in knee osteoarthritis
Read the detailed description
This is a randomizd, placbo-controlled, crossover trial comparing a single dose of celecoxib to placebo measuring the time to onset of acute pain in a paced 20-minute walk.
40 subjects will be enrolled
- Conditions
- Knee Osteoarthritis
- Being tested
- celecoxib
- Keywords
- pain, osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
time to onset of severe pain
Secondary outcomes (1)
time to onset of moderate pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJun 2004
- Primary completion1 Sep 2005
- Study completion1 Sep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Michele M Hooper, MD, MS, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194090
- Sponsor's protocol ID
- 06-04-41
- Status last verified
- Aug 2022
- First submitted
- 13 Sep 2005
- Last updated
- 26 Aug 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, 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
- NCT00194090
- Acronym / sponsor ID
- 06-04-41
- Conditions
- Knee Osteoarthritis
- Keywords
- pain, osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2004 (actual)
- Primary completion
- 1 Sep 2005 (actual)
- Study completion
- 1 Sep 2005 (actual)
- First posted
- 19 Sep 2005 (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.
A paced 20-minute walk is a reproducible model for acute pain in knee osteoarthritis
Detailed description
This is a randomizd, placbo-controlled, crossover trial comparing a single dose of celecoxib to placebo measuring the time to onset of acute pain in a paced 20-minute walk.
40 subjects will be enrolled
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Knee osteoarthritis by ACR clinical criteria Pain of at least 40 mm by VAS at baseline
- -
Key exclusion criteria (1 listed)
- Non-pregant, non-lactating Able to stop active arthritis medication for washout Cardiovascular risk factors Abnormal EKG -
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 |
|---|---|---|
| celecoxib | Drug | – |
Primary outcome
time to onset of severe pain
1 secondary outcome
time to onset of moderate pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- hospital site to inquire about clinical trialsLink provided by the sponsor.
Related trials for Knee Osteoarthritis
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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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.
Michele M Hooper, MD, MS 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 4 study testing celecoxib in people with Knee Osteoarthritis, 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 26 Aug 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
time to onset of severe pain. 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 26 Aug 2022.