Back PainPhase 4NCT00290901
Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.
A Phase 4 study testing Tramadol Hydrochloride 50mg and Celebrex 200mg in people with Back Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 54 sites in 2 countries.
Trial summary
This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- What is being tested?
- Tramadol Hydrochloride 50mg and Celebrex 200mg
- How many people
- 754 participants
- Where
- 54 sitesin 2 countries
- Study dates
- Mar 2006to Dec 2006
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject presents with duration of chronic low back pain of > 3 months requiring regular use of analgesics (> 4 days/week), except for acetaminophen which cannot have been the sole analgesic used.
Who cannot join
- The subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy)
Trial locations and contacts
54 sites in 2 countries.
54 sites in 2 countries
United States53 sites
Pfizer Investigational Site
Anaheim, California
Pfizer Investigational Site
Arkansas City, Kansas
Pfizer Investigational Site
Arlington, Virginia
Pfizer Investigational Site
Austin, Texas
Pfizer Investigational Site
Baltimore, Maryland
Pfizer Investigational Site
Boulder, Colorado
Pfizer Investigational Site
Brooklyn, New York
Pfizer Investigational Site
Camp Hill, Pennsylvania
Pfizer Investigational Site
Charleston, South Carolina
Pfizer Investigational Site
Colorado Springs, Colorado
Pfizer Investigational Site
Columbia, South Carolina
Pfizer Investigational Site
Cos Cob, Connecticut
Pfizer Investigational Site
Danville, Virginia
Pfizer Investigational Site
Decatur, Georgia
Pfizer Investigational Site
Denver, Colorado
Pfizer Investigational Site
Duncansville, Pennsylvania
Pfizer Investigational Site
Jackson, Mississippi
Pfizer Investigational Site
Johnson City, Tennessee
Pfizer Investigational Site
Kansas City, Missouri
Pfizer Investigational Site
La Mesa, California
Pfizer Investigational Site
Libertyville, Illinois
Pfizer Investigational Site
Little Rock, Arkansas
Pfizer Investigational Site
Long Beach, California
Pfizer Investigational Site
Madisonville, Kentucky
Pfizer Investigational Site
Medford, Oregon
Pfizer Investigational Site
Miami, Florida
Pfizer Investigational Site
Morton Grove, Illinois
Pfizer Investigational Site
New Tazewell, Tennessee
Pfizer Investigational Site
New York, New York
Pfizer Investigational Site
Oceanside, California
Pfizer Investigational Site
Omaha, Nebraska
Pfizer Investigational Site
Overland Park, Kansas
Pfizer Investigational Site
Paramount, California
Pfizer Investigational Site
Pembroke Pines, Florida
Pfizer Investigational Site
Phoenix, Arizona
Pfizer Investigational Site
Portland, Oregon
Pfizer Investigational Site
Raleigh, North Carolina
Pfizer Investigational Site
Rochester, New York
Pfizer Investigational Site
Sacramento, California
Pfizer Investigational Site
San Angelo, Texas
Pfizer Investigational Site
San Antonio, Texas
Pfizer Investigational Site
San Francisco, California
Pfizer Investigational Site
San Luis Obispo, California
Pfizer Investigational Site
Scottsdale, Arizona
Pfizer Investigational Site
St Louis, Missouri
Pfizer Investigational Site
Tucson, Arizona
Pfizer Investigational Site
Tustin, California
Pfizer Investigational Site
Vista, California
Pfizer Investigational Site
Washington D.C., District of Columbia
Pfizer Investigational Site
West Palm Beach, Florida
Pfizer Investigational Site
Wheaton, Maryland
Pfizer Investigational Site
Wichita, Kansas
Pfizer Investigational Site
Woodstock, Georgia
About this study
Official title: A Six Week Double-Blind, Randomized, Multicenter Comparison Study of the Analgesic Effectiveness of Celecoxib 200 mg BID Compared to Tramadol Hydrochloride 50 mg QID in Subjects With Chronic Low Back Pain
This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period.
- Conditions
- Back Pain
- Being tested
- Tramadol Hydrochloride 50mg, Celebrex 200mg
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol Hydrochloride 50mgDrug
Celebrex 200mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6.
Secondary outcomes (1)
To compare the effects of treatment with celecoxib 200 mg BID and tramadol hydrochloride 50 mg QID on improvement in functionality and quality of life in subjects with chronic low back pain.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Enrolment
- 754 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290901
- Sponsor's protocol ID
- A3191165
- Status last verified
- Mar 2021
- First submitted
- 9 Feb 2006
- Last updated
- 3 Mar 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six Week Double-Blind, Randomized, Multicenter Comparison Study of the Analgesic Effectiveness of Celecoxib 200 mg BID Compared to Tramadol Hydrochloride 50 mg QID in Subjects With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00290901
- Acronym / sponsor ID
- A3191165
- Conditions
- Back Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 754 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Dec 2006 (actual)
- First posted
- 13 Feb 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.
This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The subject presents with duration of chronic low back pain of > 3 months requiring regular use of analgesics (> 4 days/week), except for acetaminophen which cannot have been the sole analgesic used.
Key exclusion criteria (1 listed)
- The subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy)
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 |
|---|---|---|
| Tramadol Hydrochloride 50mg | Drug | – |
| Celebrex 200mg | Drug | – |
Primary outcome
To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6.
1 secondary outcome
To compare the effects of treatment with celecoxib 200 mg BID and tramadol hydrochloride 50 mg QID on improvement in functionality and quality of life in subjects with chronic low back 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 3 Mar 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
54 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tramadol Hydrochloride 50mg and Celebrex 200mg in people with Back Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 54 sites in 2 countries.
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 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 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Puerto Rico. 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?
To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6.. 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 3 Mar 2021.