PainPhase 3NCT00140933
A Study to Evaluate Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome
A Phase 3 study testing MK0966; rofecoxib in people with Pain, run by Merck Sharp & Dohme LLC at 1 site in France.
Trial summary
Comparing the short-term efficacy of rofecoxib versus placebo. Patients receive rofecoxib or placebo or diclofenac and fill out a patient diary on daytime pain severity during daily activities, night pain severity, and acetaminophen/paracetamol intake. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Pain
- What is being tested?
- MK0966; rofecoxib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2003to not given
- Phase
- Phase 3
- 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males or females between the ages of 18 and 59 with acute painful rotator cuff syndrome.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, 7-Day Study of the Efficacy and Safety of Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome
Comparing the short-term efficacy of rofecoxib versus placebo. Patients receive rofecoxib or placebo or diclofenac and fill out a patient diary on daytime pain severity during daily activities, night pain severity, and acetaminophen/paracetamol intake.
- Conditions
- Pain
- Being tested
- MK0966; rofecoxib, Comparator: diclofenac, placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0966; rofecoxibDrug
Comparator: diclofenac, placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during daily activities assessed by a Numerical Rating Score (NRS)
Secondary outcomes (4)
Functional impairment evaluated using Neer's functional index.
Global assessment of disease activity by the patient with a NRS.
Intensity of night pain evaluated by NRS.
Rescue treatment take during the study duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 274 participants
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140933
- Sponsor's protocol ID
- 2005_056
- Status last verified
- Dec 2006
- First submitted
- 30 Aug 2005
- Last updated
- 5 Dec 2006
- Results posted
- No
Publications
Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3.
PubMed 32797734
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, 7-Day Study of the Efficacy and Safety of Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome
- ClinicalTrials.gov ID
- NCT00140933
- Acronym / sponsor ID
- 2005_056
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 274 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- First posted
- 1 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.
Comparing the short-term efficacy of rofecoxib versus placebo. Patients receive rofecoxib or placebo or diclofenac and fill out a patient diary on daytime pain severity during daily activities, night pain severity, and acetaminophen/paracetamol intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males or females between the ages of 18 and 59 with acute painful rotator cuff syndrome.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MK0966; rofecoxib | Drug | – |
| Comparator: diclofenac, placebo | Drug | – |
Primary outcome
Pain during daily activities assessed by a Numerical Rating Score (NRS)
4 secondary outcomes
Functional impairment evaluated using Neer's functional index.
Global assessment of disease activity by the patient with a NRS.
Intensity of night pain evaluated by NRS.
Rescue treatment take during the study duration.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2006.
- Derived from this study: PubMed 32797734Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MK0966; rofecoxib in people with Pain, run by Merck Sharp & Dohme LLC at 1 site in France.
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 1 inclusion and 0 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 5 Dec 2006. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
Pain during daily activities assessed by a Numerical Rating Score (NRS). 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 NCT00140933, 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 5 Dec 2006.