Low Back PainPhase 4NCT00640432
Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain
A Phase 4 study testing Diclofenac and Celecoxib in people with Low Back Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 9 sites in Brazil.
Trial summary
To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with acute low back pain Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Diclofenac and Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 9 sitesBrazil
- Study dates
- Oct 2003to Oct 2004
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years
- Acute low back pain that falls into 1st or 2nd class of 'Quebec Task Force' classification of moderate to severe intensity (>50 mm in the VAS)
- Acute low back pain onset <72 hours prior to study inclusion and >6 weeks after the last acute low back pain episode
Who cannot join
- Scoliosis or known history of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or any other disease that cause pain
- Low back pain from major trauma or visceral disorder
- Esophageal ulcers, gastric or duodenal ulcers or bleeding within 30 days prior to being administered study drug
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Brazil9 sites
Pfizer Investigational Site
Goiânia, Goiás, 74043-110
Pfizer Investigational Site
Goiânia, Goiás, 74075-020
Pfizer Investigational Site
Goiânia, Goiás, 74605-050
Pfizer Investigational Site
Londrina, Paraná, 86010-010
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 21215-020
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 21941-590
Pfizer Investigational Site
Salvador, Estado de Bahia, 40420-000
Pfizer Investigational Site
São Paulo, São Paulo, 04039-004
Pfizer Investigational Site
São Paulo, São Paulo, 08270-070
About this study
Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of The Safety, Tolerability And Efficacy Of Celecoxib 200 Mg Twice A Day (With A 400 Mg Attack Dose) Versus Sodium Diclofenac 75 Mg Twice A Day In Subjects With Acute Low Back Pain
To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with acute low back pain
- Conditions
- Low Back Pain
- Being tested
- Diclofenac, Celecoxib
- 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.
DiclofenacDrug
75 mg oral capsule twice daily for 7 days
CelecoxibDrug
400 mg oral capsule followed by 200 mg oral capsule with the evening meal (>=4 hours from first dose) on Day 1 then 200 mg oral capsule twice daily for 6 days
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Diclofenac |
| B | Experimental | Not described Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment
Measured: Day 3
Secondary outcomes (9)
Subject's quality of life, as measured by the SF-36 Health Survey
Measured: Day 7
Physical examination
Measured: Days 3 and 7
Pain relief score
Measured: Days 3 and 7
Vital signs
Measured: Days 3 and 7
Adverse events
Measured: Days 3 and 7
Change from baseline in VAS pain intensity assessment
Measured: Day 7
Categorical pain intensity score
Measured: Days 3 and 7
Subject's global assessment score
Measured: Days 3 and 7
Subject's functional ability, as measured by the "Roland Morris" Questionnaire about low back pain and disability
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startOct 2003
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 244 participants (actual)
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
- NCT00640432
- Sponsor's protocol ID
- A3191064
- Status last verified
- Jan 2021
- First submitted
- 17 Mar 2008
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of The Safety, Tolerability And Efficacy Of Celecoxib 200 Mg Twice A Day (With A 400 Mg Attack Dose) Versus Sodium Diclofenac 75 Mg Twice A Day In Subjects With Acute Low Back Pain
- ClinicalTrials.gov ID
- NCT00640432
- Acronym / sponsor ID
- A3191064
- Conditions
- Low Back Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- Oct 2004 (actual)
- First posted
- 21 Mar 2008 (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.
To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with acute low back pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Diclofenac |
| B | Experimental | Drug: Celecoxib |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18 and 65 years
- Acute low back pain that falls into 1st or 2nd class of 'Quebec Task Force' classification of moderate to severe intensity (>50 mm in the VAS)
- Acute low back pain onset <72 hours prior to study inclusion and >6 weeks after the last acute low back pain episode
Key exclusion criteria (3 listed)
- Scoliosis or known history of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or any other disease that cause pain
- Low back pain from major trauma or visceral disorder
- Esophageal ulcers, gastric or duodenal ulcers or bleeding within 30 days prior to being administered study drug
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 |
|---|---|---|
| Diclofenac75 mg oral capsule twice daily for 7 days | Drug | A |
| Celecoxib400 mg oral capsule followed by 200 mg oral capsule with the evening meal (>=4 hours from first dose) on Day 1 then 200 mg oral capsule twice daily for 6 days | Drug | B |
Primary outcome
Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment
Time frame: Day 3
9 secondary outcomes
Subject's quality of life, as measured by the SF-36 Health Survey
Time frame: Day 7
Physical examination
Time frame: Days 3 and 7
Pain relief score
Time frame: Days 3 and 7
Vital signs
Time frame: Days 3 and 7
Adverse events
Time frame: Days 3 and 7
Change from baseline in VAS pain intensity assessment
Time frame: Day 7
Categorical pain intensity score
Time frame: Days 3 and 7
Subject's global assessment score
Time frame: Days 3 and 7
Subject's functional ability, as measured by the "Roland Morris" Questionnaire about low back pain and disability
Time frame: Day 7
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 2 Feb 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
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac and Celecoxib in people with Low Back Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 9 sites in Brazil.
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 3 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Brazil. 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?
Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment (time frame: Day 3). 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 2 Feb 2021.