Chronic Low Back PainPhase 4NCT00090181
Study of MK0663 in Patients With Chronic Low Back Pain (0663-806)(COMPLETED)
A Phase 4 study testing MK0663, etoricoxib / Duration of Treatment: 4 weeks and Comparator: diclofenac / Duration of Treatment: 4 weeks in people with Chronic Low Back Pain, run by Organon and Co.
Trial summary
The purpose of this study is to evaluate the efficacy of MK0663 for the treatment of chronic low back pain and to investigate the overall safety and tolerability over four weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- MK0663, etoricoxib / Duration of Treatment: 4 weeks and Comparator: diclofenac / Duration of Treatment: 4 weeks
- How many people
- 401 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients 18 years of age or older, who have Chronic Low Back Pain after the discontinuation of their previous medication for their condition.
- Patients should have at least 3 months of Low Back Pain.
Who cannot join
None listed.
About this study
Official title: A Double-Blind, Parallel-group, 4-Week Trial to Assess the Efficacy and Safety of Etoricoxib 60 mg and Diclofenac 150 mg in Patients With Chronic Low Back Pain
The purpose of this study is to evaluate the efficacy of MK0663 for the treatment of chronic low back pain and to investigate the overall safety and tolerability over four weeks of treatment.
- Conditions
- Chronic Low Back Pain
- Being tested
- MK0663, etoricoxib / Duration of Treatment: 4 weeks, Comparator: diclofenac / Duration of Treatment: 4 weeks
- Keywords
- Arcoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0663, etoricoxib / Duration of Treatment: 4 weeksDrug
Comparator: diclofenac / Duration of Treatment: 4 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower back pain intensity
Safety and tolerability
Secondary outcomes (2)
Disability questionnaire
Patient global assessment of response to therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2004 (estimated)
- Study startJun 2004
- Primary completionMar 2005
- Study completionMar 2005
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 Chronic Low Back PainStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090181
- Sponsor's protocol ID
- 0663-806
- Other IDs
- 2004_003
- Status last verified
- Feb 2022
- First submitted
- 25 Aug 2004
- Last updated
- 15 Feb 2022
- Results posted
- No
Publications
Zerbini C, Ozturk ZE, Grifka J, Maini M, Nilganuwong S, Morales R, Hupli M, Shivaprakash M, Giezek H; Etoricoxib CLBP Study Group. Efficacy of etoricoxib 60 mg/day and diclofenac 150 mg/day in reduction of pain and disability in patients with chronic low back pain: results of a 4-week, multinational, randomized, double-blind study. Curr Med Res Opin. 2005 Dec;21(12):2037-49. doi: 10.1185/030079905X75069.
PubMed 16368055
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Parallel-group, 4-Week Trial to Assess the Efficacy and Safety of Etoricoxib 60 mg and Diclofenac 150 mg in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00090181
- Acronym / sponsor ID
- 0663-806
- Conditions
- Chronic Low Back Pain
- Keywords
- Arcoxia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 27 Aug 2004 (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 evaluate the efficacy of MK0663 for the treatment of chronic low back pain and to investigate the overall safety and tolerability over four weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female patients 18 years of age or older, who have Chronic Low Back Pain after the discontinuation of their previous medication for their condition.
- Patients should have at least 3 months of Low Back Pain.
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 |
|---|---|---|
| MK0663, etoricoxib / Duration of Treatment: 4 weeks | Drug | – |
| Comparator: diclofenac / Duration of Treatment: 4 weeks | Drug | – |
Primary outcome
Lower back pain intensity
Safety and tolerability
2 secondary outcomes
Disability questionnaire
Patient global assessment of response to therapy
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 15 Feb 2022.
- Background: PubMed 16368055Zerbini C, Ozturk ZE, Grifka J, Maini M, Nilganuwong S, Morales R, Hupli M, Shivaprakash M, Giezek H; Etoricoxib CLBP Study Group. Efficacy of etoricoxib 60 mg/day and diclofenac 150 mg/day in reduction of pain and disability in patients with chronic low back pain: results of a 4-week, multinational, randomized, double-blind study. Curr Med Res Opin. 2005 Dec;21(12):2037-49. doi: 10.1185/030079905X75069.
Related trials for Chronic Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic 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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MK0663, etoricoxib / Duration of Treatment: 4 weeks and Comparator: diclofenac / Duration of Treatment: 4 weeks in people with Chronic Low Back Pain, run by Organon and Co.
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 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: finished, as of the sponsor's last update on 15 Feb 2022. 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. 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?
Lower back pain intensity. The study lists 2 primary outcomes in all. 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 NCT00090181, 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 15 Feb 2022.