Tolerability and Efficacy of Ibuprofen 800 mg in a Walking Model of Osteoarthritis Pain (0000-057)

A Phase 1 study testing ibuprofen in people with Osteoarthritis, Knee, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of the study is to see if generic ibuprofen has an effect on osteoarthritis knee pain during a series of timed walks on a treadmill. Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: ibuprofen
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 33 participants
Where: No sites listed yet
Study dates: Mar 2007to Dec 2007
Phase: Phase 1
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 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The primary source of pain is the study knee of one lower extremity
Patient is willing to limit alcohol and caffeine intake
Aside from osteoarthritis, patient is in generally good health
Patient is capable of completing protocol specified walks
Patient is able to understand and complete questionnaires in English
Patient has previously benefited from the use of either NSAIDs, COX-2 inhibitors, or acetaminophen

Who cannot join

Patient has another condition which could interfere with evaluating pain in the knee being tested
Patient is not able to take a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen
Patient has a history or current evidence of stroke, transient ischemic attack, liver disease or cancer
Patient has a history or current evidence of dizziness, unsteadiness, or falling
Patient has congestive heart failure, unstable angina or uncontrolled high blood pressure
Patient has a history of stomach, digestive track, or small intestine surgery
Patient is unable to complete the study questionnaires in English

About this study

Official title: A Randomized, Placebo-Controlled Single-Dose 3-Period Crossover Study to Assess the Tolerability and Efficacy of Ibuprofen 800 mg in a Walking Model of Osteoarthritis Pain

The purpose of the study is to see if generic ibuprofen has an effect on osteoarthritis knee pain during a series of timed walks on a treadmill.

Conditions: Osteoarthritis, Knee
Being tested: ibuprofen, Placebo
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ibuprofenDrug
Patients will receive 800 mg ibuprofen in one of the three treatment periods.
PlaceboDrug
Patients will receive placebo to ibuprofen in two of the three treatment periods.

Study groups in NCT00565084
Study group	Role	What they receive
1	Active comparator	Ibuprofen Receives: Drug: ibuprofen
2	Placebo comparator	Placebo 1 Receives: Drug: Placebo
3	Placebo comparator	Placebo 2 Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks
Pain intensities(PIs) were measured at pre-dose and 3 post-dose walks (15 Minutes Each Separated by a 45-Minute Rest Interval) on an 11 point scale(0=no pain; 10=worst pain) and averaged for each walk.
Change from baseline was average of post-dose PIs minus average of pre-dose PI.
Measured: All pain intensities measured from the pre-treatment walk and 3 post-treatment walks (within 3 and half hours post dose, 15 minutes each walk separated by a 45-minute rest interval)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Dec 2007

First posted29 Nov 2007 (estimated)
Study startMar 2007
Primary completionDec 2007
Study completionDec 2007

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00565084
Sponsor's protocol ID: 0000-057
Other IDs: 057, 2007_649
Status last verified: Mar 2015
First submitted: 28 Nov 2007
Last updated: 10 Apr 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Peeva E, Beals CR, Bolognese JA, Kivitz AJ, Taber L, Harman A, Smugar SS, Moskowitz RW. A walking model to assess the onset of analgesia in osteoarthritis knee pain. Osteoarthritis Cartilage. 2010 May;18(5):646-53. doi: 10.1016/j.joca.2009.12.008. Epub 2010 Feb 6.
PubMed 20175977

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-Controlled Single-Dose 3-Period Crossover Study to Assess the Tolerability and Efficacy of Ibuprofen 800 mg in a Walking Model of Osteoarthritis Pain
ClinicalTrials.gov ID: NCT00565084
Acronym / sponsor ID: 0000-057
Conditions: Osteoarthritis, Knee
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 29 Nov 2007 (estimated)
Results: Posted 7 Jul 2009

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 the study is to see if generic ibuprofen has an effect on osteoarthritis knee pain during a series of timed walks on a treadmill.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1	Active comparator	Drug: ibuprofenIbuprofen
2	Placebo comparator	Drug: PlaceboPlacebo 1
3	Placebo comparator	Drug: PlaceboPlacebo 2

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

The primary source of pain is the study knee of one lower extremity
Patient is willing to limit alcohol and caffeine intake
Aside from osteoarthritis, patient is in generally good health
Patient is capable of completing protocol specified walks
Patient is able to understand and complete questionnaires in English

Key exclusion criteria (7 listed)

Patient has another condition which could interfere with evaluating pain in the knee being tested
Patient is not able to take a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen
Patient has a history or current evidence of stroke, transient ischemic attack, liver disease or cancer
Patient has a history or current evidence of dizziness, unsteadiness, or falling
Patient has congestive heart failure, unstable angina or uncontrolled high blood pressure

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
ibuprofenPatients will receive 800 mg ibuprofen in one of the three treatment periods.	Drug	1
PlaceboPatients will receive placebo to ibuprofen in two of the three treatment periods.	Drug	2, 3

Primary outcome

Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks
Time frame: All pain intensities measured from the pre-treatment walk and 3 post-treatment walks (within 3 and half hours post dose, 15 minutes each walk separated by a 45-minute rest interval)
Pain intensities(PIs) were measured at pre-dose and 3 post-dose walks (15 Minutes Each Separated by a 45-Minute Rest Interval) on an 11 point scale(0=no pain; 10=worst pain) and averaged for each walk. Change from baseline was average of post-dose PIs minus average of pre-dose PI.

Results and safety

Results posted to the registry on 7 Jul 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo-Placebo-Ibuprofen	11	11
Placebo-Ibuprofen-Placebo	11	11
Ibuprofen-Placebo-Placebo	11	11

Primary outcome: Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks

Time frame: All pain intensities measured from the pre-treatment walk and 3 post-treatment walks (within 3 and half hours post dose, 15 minutes each walk separated by a 45-minute rest interval). Least squares mean (Standard Deviation). Unit: Units on a Scale

Measure	Ibuprofen n = 33	Placebo 1 n = 33	Placebo 2 n = 33
Value	0.24 (0.77)	0.18 (0.77)	0.18 (0.77)

Ibuprofen vs Placebo 1 vs Placebo 2: Difference in LS Means: 0.06 (90% CI -0.23 to 0.35), p = 0.743, ANOVA

Population analysed: This is a crossover study. Total number of participants was 33; every participant had one ibuprofen period and two placebo periods.

Adverse events

Time frame: From consent to 14 day follow up after all treatment periods was from 16-Mar-2007 to 10-Dec-2007. First study dosing to last dosing period was from 23-Mar-2007 to 03-Dec-2007.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo-Placebo-Ibuprofen	0 of 11 (0%)	3 of 11 (27.3%)	Not reported
Placebo-Ibuprofen-Placebo	0 of 11 (0%)	3 of 11 (27.3%)	Not reported
Ibuprofen-Placebo-Placebo	1 of 11 (9.1%)	3 of 11 (27.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20175977Peeva E, Beals CR, Bolognese JA, Kivitz AJ, Taber L, Harman A, Smugar SS, Moskowitz RW. A walking model to assess the onset of analgesia in osteoarthritis knee pain. Osteoarthritis Cartilage. 2010 May;18(5):646-53. doi: 10.1016/j.joca.2009.12.008. Epub 2010 Feb 6.

Related trials for Osteoarthritis, Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ibuprofen in people with Osteoarthritis, Knee, run by Merck Sharp & Dohme LLC.

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 6 inclusion and 7 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 10 Apr 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 7 Jul 2009). 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 Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks (time frame: All pain intensities measured from the pre-treatment walk and 3 post-treatment walks (within 3 and half hours post dose, 15 minutes each walk separated by a 45-minute rest interval)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00565084, which also lists 1 linked publication.

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 10 Apr 2015.