Low Back PainPhase 4NCT00649610
Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily Compared With Diclofenac 75 mg Twice Daily in Acute Low Back Pain
A Phase 4 study testing valdecoxib and diclofenac in people with Low Back Pain, run by Pfizer at 29 sites in 9 countries.
Trial summary
The pain relief, safety, and tolerability of valdecoxib 40 mg once daily compared with diclofenac 75 mg twice daily for acute low back pain was studied. The effect of valdecoxib on the patient's level of disability and quality of life was also studied. 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?
- valdecoxib and diclofenac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 29 sitesin 9 countries
- Study dates
- Nov 2002to May 2003
- 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
- Acute low back pain, defined as either class 1a or class 2a according to the Quebec Task Force Classification and categorized as moderate-severe in the Pain Intensity Categorical Scale and Visual analogue score (VAS) greater or equal to 50 mm
- Acute low back pain was to have started at least 72 hours prior to inclusion in the trial and more than 6 weeks after the last episode of acute low back pain
- History of at least 1 reported episode of acute low back pain in the last 5 years
Who cannot join
- History of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or other diseases known to cause pain
- Moderate to severe scoliosis
- Back pain due to major trauma or visceral disorder
- Unwilling to refrain from commencing concomitant physiotherapy
- Active or suspected esophageal, gastric pyloric channel, or duodenal ulceration or bleeding within 30 days prior to the first dose of study medication
- Any known laboratory abnormality, which in the opinion of the investigator, would contraindicate study participation
- Subject was pregnant or lactating woman , or was a woman of childbearing potential not using an acceptable method of contraception
Trial locations and contacts
29 sites in 9 countries.
29 sites in 9 countries
Brazil8 sites
Pfizer Investigational Site
Curitiba, Paraná, 80430-210
Pfizer Investigational Site
Curitiba, Paraná
Pfizer Investigational Site
Goiânia, Goiás, 74085-450
Pfizer Investigational Site
Petrópolis, Rio de Janeiro, 25620-040
Pfizer Investigational Site
São Paulo, São Paulo, 04023-900
Pfizer Investigational Site
São Paulo, São Paulo, 04029-000
Pfizer Investigational Site
São Paulo, São Paulo, 05001-000
Pfizer Investigational Site
São Paulo, São Paulo, 05403-012
Mexico6 sites
Pfizer Investigational Site
Puebla City, Puebla, 72000
Pfizer Investigational Site
Puebla City, Puebla, 72070
Pfizer Investigational Site
Puebla City, Puebla, 72410
Pfizer Investigational Site
Toluca, EDO. de Mexico, 50080
Pfizer Investigational Site
Zapopan, Jalisco, 45040
Pfizer Investigational Site
Zapopan, Jalisco, 45200
Venezuela4 sites
Pfizer Investigational Site
Caracas, DF, 1020
Pfizer Investigational Site
Caracas, DF, 1051
Pfizer Investigational Site
Caracas, DF, 1070
Pfizer Investigational Site
Caracas
Colombia3 sites
Pfizer Investigational Site
Bogotá, D.C.
Pfizer Investigational Site
Bogota D.C
Pfizer Investigational Site
Cali-valle
Argentina2 sites
Pfizer Investigational Site
Bs. As.
Pfizer Investigational Site
Buenos Aires, C1221ACI
Costa Rica2 sites
Pfizer Investigational Site
Cartago, Cartago Province, 7051
Pfizer Investigational Site
Hatillo Centro, Provincia de San José, 476-1002
Peru2 sites
Pfizer Investigational Site
Lima, Lima Province, LIMA 11
Pfizer Investigational Site
Lima, Lima Province, LIMA 27
About this study
Official title: Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily vs. Diclofenac 75 mg Twice Daily in Subjects With Acute Low Back Pain
The pain relief, safety, and tolerability of valdecoxib 40 mg once daily compared with diclofenac 75 mg twice daily for acute low back pain was studied. The effect of valdecoxib on the patient's level of disability and quality of life was also studied.
- Conditions
- Low Back Pain
- Being tested
- valdecoxib, diclofenac
- Keywords
- acute low back pain
- 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.
valdecoxibDrug
valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day
diclofenacDrug
diclofenac 75 mg twice daily (BID) for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: valdecoxib |
| Arm 2 | Active comparator | Not described Receives: Drug: diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline
Measured: Day 3
Secondary outcomes (7)
Patient global evaluation
Measured: Day 3 and Day 7
Subject's functional capacity as measured by the Oswestry Low Back Pain and Disability Questionnaire
Measured: Day 7
Subject's quality of life as measured by the Acute short form (SF)-36 (8 domains)
Measured: Day 7
Pain Relief
Measured: Day 3 and Day 7
Composite Upper Gastrointestinal (UGI) Tolerability was calcluated. A subject had a UGI event if the subject reported at least 1 of the following: moderate or severe nausea, or moderate or severe abdominal pain, or moderate or severe dyspepsia
Measured: Day 7
VAS Pain Intensity (0-100 mm)
Measured: Day 7
Categorical Pain Intensity
Measured: Day 3 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startNov 2002
- Study completionMay 2003
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.
- More trials run by PfizerThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00649610
- Sponsor's protocol ID
- A3471012
- Status last verified
- Mar 2008
- First submitted
- 28 Mar 2008
- Last updated
- 10 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily vs. Diclofenac 75 mg Twice Daily in Subjects With Acute Low Back Pain
- ClinicalTrials.gov ID
- NCT00649610
- Acronym / sponsor ID
- A3471012
- Conditions
- Low Back Pain
- Keywords
- acute low back pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- May 2003 (actual)
- First posted
- 1 Apr 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.
The pain relief, safety, and tolerability of valdecoxib 40 mg once daily compared with diclofenac 75 mg twice daily for acute low back pain was studied. The effect of valdecoxib on the patient's level of disability and quality of life was also studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: valdecoxib |
| Arm 2 | Active comparator | Drug: diclofenac |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute low back pain, defined as either class 1a or class 2a according to the Quebec Task Force Classification and categorized as moderate-severe in the Pain Intensity Categorical Scale and Visual analogue score (VAS) greater or equal to 50 mm
- Acute low back pain was to have started at least 72 hours prior to inclusion in the trial and more than 6 weeks after the last episode of acute low back pain
- History of at least 1 reported episode of acute low back pain in the last 5 years
Key exclusion criteria (7 listed)
- History of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or other diseases known to cause pain
- Moderate to severe scoliosis
- Back pain due to major trauma or visceral disorder
- Unwilling to refrain from commencing concomitant physiotherapy
- Active or suspected esophageal, gastric pyloric channel, or duodenal ulceration or bleeding within 30 days prior to the first dose of study medication
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 |
|---|---|---|
| valdecoxibvaldecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day | Drug | Arm 1 |
| diclofenacdiclofenac 75 mg twice daily (BID) for 7 days | Drug | Arm 2 |
Primary outcome
Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline
Time frame: Day 3
7 secondary outcomes
Patient global evaluation
Time frame: Day 3 and Day 7
Subject's functional capacity as measured by the Oswestry Low Back Pain and Disability Questionnaire
Time frame: Day 7
Subject's quality of life as measured by the Acute short form (SF)-36 (8 domains)
Time frame: Day 7
Pain Relief
Time frame: Day 3 and Day 7
Composite Upper Gastrointestinal (UGI) Tolerability was calcluated. A subject had a UGI event if the subject reported at least 1 of the following: moderate or severe nausea, or moderate or severe abdominal pain, or moderate or severe dyspepsia
Time frame: Day 7
VAS Pain Intensity (0-100 mm)
Time frame: Day 7
Categorical Pain Intensity
Time frame: Day 3 and 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 10 Apr 2008.
- 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
29 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valdecoxib and diclofenac in people with Low Back Pain, run by Pfizer at 29 sites in 9 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 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 10 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Brazil, Mexico, Venezuela, Colombia, Argentina and 4 more countries. 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?
Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline (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 10 Apr 2008.