Recurrent Low Back PainPhase 3NCT00393211
Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-042)
A Phase 3 study testing MK0663, Etoricoxib / Duration of Treatment : 12 Weeks in people with Recurrent Low Back Pain, run by Organon and Co.
Trial summary
Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Low Back Pain
- What is being tested?
- MK0663, Etoricoxib / Duration of Treatment : 12 Weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 319 participants
- Where
- No sites listed yet
- Study dates
- Apr 2000to Nov 2000
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low back pain for previous 3 months and majority of days in last month
- Regular use of acetaminophen or NSAID to treat low back pain in past month
- Judged to be in otherwise good health
Who cannot join
- Low back pain that is due to secondary causes
- Radicular/myelopathic pain
- Surgery for low back pain within the past 6 months
- Active lawsuit or claim pertaining to their low back pain
- Disease that may confound the results of the study or pose risk to the patients
- Corticosteroid use in past month
- Previous participation in an MK0663 study
About this study
Official title: A Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial to Assess the Efficacy and Safety of MK0663 in Patients With Chronic Low Back Pain
Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back pain.
- Conditions
- Recurrent Low Back Pain
- Being tested
- MK0663, Etoricoxib / Duration of Treatment : 12 Weeks, Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0663, Etoricoxib / Duration of Treatment : 12 WeeksDrug
Comparator : placebo (unspecified) /Duration of Treatment : 12 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain intensity scale (0-100 mm VAS) over 4 weeks compared to placebo
Secondary outcomes (1)
Low back pain intensity scale (0-100 mm VAS) over 12 weeks compared to placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2006 (estimated)
- Study startApr 2000
- Primary completionNov 2000
- Study completionNov 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Recurrent 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 319 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
- NCT00393211
- Sponsor's protocol ID
- 0663-042
- Other IDs
- 2006_547
- Status last verified
- Feb 2022
- First submitted
- 26 Oct 2006
- Last updated
- 18 Feb 2022
- Results posted
- No
Publications
Birbara CA, Puopolo AD, Munoz DR, Sheldon EA, Mangione A, Bohidar NR, Geba GP; Etoricoxib Protocol 042 Study Group. Treatment of chronic low back pain with etoricoxib, a new cyclo-oxygenase-2 selective inhibitor: improvement in pain and disability--a randomized, placebo-controlled, 3-month trial. J Pain. 2003 Aug;4(6):307-15. doi: 10.1016/s1526-5900(03)00633-3.
PubMed 14622687Curtis SP, Ng J, Yu Q, Shingo S, Bergman G, McCormick CL, Reicin AS. Renal effects of etoricoxib and comparator nonsteroidal anti-inflammatory drugs in controlled clinical trials. Clin Ther. 2004 Jan;26(1):70-83. doi: 10.1016/s0149-2918(04)90007-0.
PubMed 14996519Sheldon EA, Bird SR, Smugar SS, Tershakovec AM. Correlation of measures of pain, function, and overall response: results pooled from two identical studies of etoricoxib in chronic low back pain. Spine (Phila Pa 1976). 2008 Mar 1;33(5):533-8. doi: 10.1097/BRS.0b013e3181657d24.
PubMed 18317199
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial to Assess the Efficacy and Safety of MK0663 in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00393211
- Acronym / sponsor ID
- 0663-042
- Conditions
- Recurrent Low Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Apr 2000
- Primary completion
- Nov 2000 (actual)
- Study completion
- Nov 2000 (actual)
- First posted
- 27 Oct 2006 (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.
Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Low back pain for previous 3 months and majority of days in last month
- Regular use of acetaminophen or NSAID to treat low back pain in past month
- Judged to be in otherwise good health
Key exclusion criteria (7 listed)
- Low back pain that is due to secondary causes
- Radicular/myelopathic pain
- Surgery for low back pain within the past 6 months
- Active lawsuit or claim pertaining to their low back pain
- Disease that may confound the results of the study or pose risk to the patients
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 : 12 Weeks | Drug | – |
| Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks | Drug | – |
Primary outcome
Low back pain intensity scale (0-100 mm VAS) over 4 weeks compared to placebo
1 secondary outcome
Low back pain intensity scale (0-100 mm VAS) over 12 weeks compared to placebo
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 18 Feb 2022.
- Background: PubMed 14622687Birbara CA, Puopolo AD, Munoz DR, Sheldon EA, Mangione A, Bohidar NR, Geba GP; Etoricoxib Protocol 042 Study Group. Treatment of chronic low back pain with etoricoxib, a new cyclo-oxygenase-2 selective inhibitor: improvement in pain and disability--a randomized, placebo-controlled, 3-month trial. J Pain. 2003 Aug;4(6):307-15. doi: 10.1016/s1526-5900(03)00633-3.
- Background: PubMed 14996519Curtis SP, Ng J, Yu Q, Shingo S, Bergman G, McCormick CL, Reicin AS. Renal effects of etoricoxib and comparator nonsteroidal anti-inflammatory drugs in controlled clinical trials. Clin Ther. 2004 Jan;26(1):70-83. doi: 10.1016/s0149-2918(04)90007-0.
- Background: PubMed 18317199Sheldon EA, Bird SR, Smugar SS, Tershakovec AM. Correlation of measures of pain, function, and overall response: results pooled from two identical studies of etoricoxib in chronic low back pain. Spine (Phila Pa 1976). 2008 Mar 1;33(5):533-8. doi: 10.1097/BRS.0b013e3181657d24.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MK0663, Etoricoxib / Duration of Treatment : 12 Weeks in people with Recurrent 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 3 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 18 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 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 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?
Low back pain intensity scale (0-100 mm VAS) over 4 weeks compared to placebo. 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 NCT00393211, which also lists 3 linked publications.
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 Feb 2022.