Ankylosing SpondylitisPhase 3NCT00762463

Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis

A Phase 3 study testing Celecoxib and Diclofenac SR in people with Ankylosing Spondylitis, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a local, multicenter, randomized, active comparator, double-blind, parallel group study with extension will be conducted to evaluate the efficacy and safety of celecoxib versus diclofenac SR in the treatment of Chinese patients with Ankylosing Spondylitis (AS). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Ankylosing Spondylitis
What is being tested?: Celecoxib and Diclofenac SR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 5 sitesChina
Study dates: Jul 2009to Aug 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Meet the 1984 Modified New York Criteria for Classification of Ankylosing Spondylitis
With axial involvement
Without peripheral joint involvement (synovitis) at the time of study entry, (excluding involvement of the hips, knees and shoulders)
Need for daily treatment with NSAIDs during the previous 30 days before study entry

Who cannot join

Known inflammatory enteropathy (eg, ulcerative colitis, Crohn's disease, etc)
Presence of extra-articular manifestations (eg, uveitis, endocarditis, etc.)
Known vertebral compression
Need for a corset during the study

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

China5 sites

Pfizer Investigational Site
Beijing, 100020
Pfizer Investigational Site
Beijing, 100853
Pfizer Investigational Site
Chengdu, Sichuan, 610041
Pfizer Investigational Site
Guangzhou, Guangdong, 510630
Pfizer Investigational Site
Xi’an, Shanxi, 710032

Other trials in China

About this study

Official title: A 6-Week, Randomized, Double-Blind, Parallel-Group Study To Evaluate The Symptomatic Effects And Safety Of Celecoxib 200mg QD Compared To Diclofenac 75mg SR QD In Chinese Patients With Ankylosing Spondylitis, With 6-Week Extension Phase Treatment On Celecoxib 400 Mg QD Or Maintaining Double-Blind Phase Therapy

Conditions: Ankylosing Spondylitis
Being tested: Celecoxib, Diclofenac SR
Medical subject headings: Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CelecoxibDrug
capsule, 200 mg QD, 6-12 weeks
Diclofenac SRDrug
tablet, 75 mg QD,6-12 weeks

Study groups in NCT00762463
Study group	Role	What they receive
Celecoxib 200 mg QD	Experimental	Not described Receives: Drug: Celecoxib
Diclofenac SR 75 mg QD	Active comparator	Not described Receives: Drug: Diclofenac SR

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6
100-millimeter (mm) Visual Analog Scale (VAS) score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Change from baseline of less than (<) 0 indicated improvement.
Measured: Baseline, Week 6
Participant's Assessment of Global Pain Intensity at Baseline
100-mm VAS scores specified participant's assessment of global pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Lower scores indicated less pain.
Measured: Baseline

Secondary outcomes (24)

Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4
100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Change from baseline of <0 indicated improvement.
Measured: Baseline, Weeks 2, 4
Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12
100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Lower scores indicated less pain. Change from baseline of <0 indicated improvement.
Measured: Baseline, Week 12
Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6
5-point Likert scale scores specified participant's current situation in response to the following question "Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today?" 1=very good to 5=very poor. Change from baseline <0 indicated improvement.
Measured: Baseline, Weeks 2, 4, 6
Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12
5-point Likert scale scores specified participant's current situation in response to the following question "Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today?" 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline <0 indicated improvement.
Measured: Baseline, Week 12
Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6
5-point Likert scale scores specified physician's subjective assessment on how overall ankylosing spondylitis appeared at the time of participant's visit and participant's disease signs. 1=very good to 5=very poor. Change from baseline <0 indicated improvement.
Measured: Baseline, Weeks 2, 4, 6
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12
5-point Likert scale scores specified physician's subjective assessment on how the overall ankylosing spondylitis appeared at the time of the participant's visit and participant's disease signs. 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline <0 indicated improvement.
Measured: Baseline, Week 12
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6
Bath Ankylosing Spondylitis Functional Index (BASFI) was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Change from baseline <0 indicated improvement.
Measured: Baseline, Weeks 2, 4, 6
Change From Baseline in BASFI at Week 12
BASFI was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Lower scores indicated better functional health. Change from baseline <0 indicated improvement.
Measured: Baseline, Week 12
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6
Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was comprised of 6 specific questions, each answered on a 10-mm VAS scale. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Change from baseline <0 indicated improvement.
Measured: Baseline, Weeks 2, 4, 6
Change From Baseline in BASDAI at Week 12
BASDAI is comprised of 6 specific questions, each answered on a 10-mm VAS. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Lower scores indicated better health. Change from baseline <0 indicated improvement.
Measured: Baseline, Week 12
Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20
Percentages of participants who demonstrated an improvement of greater than or equal to (≥) 20% from baseline and an absolute improvement of ≥10 mm from baseline on a 100-mm VAS in ≥3 of the 4 domains proposed by the Ankylosing Spondylitis Assessment Working Group (ASAS-20).
Measured: Weeks 2, 4, 6, 12
Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6
100-mm VAS scores specified participant's nocturnal pain in response to the following question "Did you have any pain in the neck, back or hips during the previous night?" 0=no pain to 100=worst pain possible. Change from baseline <0 indicated improvement.
Measured: Baseline, Weeks 2, 4, 6
Change From Baseline in Nocturnal Pain at Week 12
100-mm VAS scores specified participant's nocturnal pain in response to the following question "Did you have any pain in the neck, back or hips during the previous night?" 0=no pain to 100=worst pain possible. Lower scores indicated less pain. Change from baseline <0 indicated improvement.
Measured: Baseline, Week 12
Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6
Fingertips to floor distance measured in centimeter (cm) from the tip of the fingers to the floor with participants standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Change from baseline <0 indicated improvement.
Measured: Baseline, Weeks 2, 4, 6
Change From Baseline in Fingertips to Floor Distance at Week 12
Fingertips to floor distance measured in cm from the tip of the fingers to the floor with participant standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Lower scores indicated better health. Change from baseline <0 represented improvement.
Measured: Baseline, Week 12
Change From Baseline in Chest Expansion at Weeks 2, 4, and 6
Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Change from baseline greater than (>) 0 represented improvement.
Measured: Baseline, Weeks 2, 4, 6
Change From Baseline in Chest Expansion at Week 12
Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Higher scores indicate better health. Change from baseline greater than (>) 0 represented improvement.
Measured: Baseline, Week 12
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 6
Erythrocyte Sedimentation Rate (ESR) was a laboratory test that providee a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h). Change from baseline <0 indicated improvement.
Measured: Baseline, Week 6
Change From Baseline in ESR at Week 12
ESR was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. Lower values indicated better health. Change from baseline <0 indicated improvement.
Measured: Baseline, Week 12
Change From Baseline in C-Reactive Protein (CRP) at Week 6
C-Reactive Protein (CRP) was a marker of inflammation, measured in milligram per liter (mg/L). Change from baseline <0 indicated improvement.
Measured: Baseline, 6 Weeks
Change From Baseline in CRP at Week 12
CRP was a marker of inflammation. Lower values indicated better health. Change from baseline <0 indicated improvement.
Measured: Baseline, Week 12
Percentage of Participants With Concomitant Use of Paracetamol
Percentage of participants who concomitantly took at least 1 paracetamol tablet as rescue medication at Week 6
Measured: Week 6
Percentage of Days With Concomitant Administration of Paracetamol
Calculated as days on rescue medication divided by days of exposure in the study at the end of Week 6.
Measured: Week 6
Paracetamol Tablets Taken Per Day by Participant
Calculated as the total number of paracetamol tablets taken divided by days of exposure in the study.
Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Aug 2010

First posted30 Sep 2008 (estimated)
Study startJul 2009
Primary completionJun 2010
Study completionAug 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ankylosing SpondylitisStudies 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: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00762463
Sponsor's protocol ID: A3191348
Status last verified: Jan 2021
First submitted: 29 Sep 2008
Last updated: 2 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Huang F, Gu J, Liu Y, Zhu P, Zheng Y, Fu J, Pan S, Le S. Efficacy and safety of celecoxib in chinese patients with ankylosing spondylitis: a 6-week randomized, double-blinded study with 6-week open-label extension treatment. Curr Ther Res Clin Exp. 2014 Dec 5;76:126-33. doi: 10.1016/j.curtheres.2014.08.002. eCollection 2014 Dec.
PubMed 25516774

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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 6-Week, Randomized, Double-Blind, Parallel-Group Study To Evaluate The Symptomatic Effects And Safety Of Celecoxib 200mg QD Compared To Diclofenac 75mg SR QD In Chinese Patients With Ankylosing Spondylitis, With 6-Week Extension Phase Treatment On Celecoxib 400 Mg QD Or Maintaining Double-Blind Phase Therapy
ClinicalTrials.gov ID: NCT00762463
Acronym / sponsor ID: A3191348
Conditions: Ankylosing Spondylitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Jun 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 30 Sep 2008 (estimated)
Results: Posted 23 Aug 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Celecoxib 200 mg QD	Experimental	Drug: Celecoxib
Diclofenac SR 75 mg QD	Active comparator	Drug: Diclofenac SR

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Meet the 1984 Modified New York Criteria for Classification of Ankylosing Spondylitis
With axial involvement
Without peripheral joint involvement (synovitis) at the time of study entry, (excluding involvement of the hips, knees and shoulders)
Need for daily treatment with NSAIDs during the previous 30 days before study entry

Key exclusion criteria (4 listed)

Known inflammatory enteropathy (eg, ulcerative colitis, Crohn's disease, etc)
Presence of extra-articular manifestations (eg, uveitis, endocarditis, etc.)
Known vertebral compression
Need for a corset during the study

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
Celecoxibcapsule, 200 mg QD, 6-12 weeks	Drug	Celecoxib 200 mg QD
Diclofenac SRtablet, 75 mg QD,6-12 weeks	Drug	Diclofenac SR 75 mg QD

Primary outcome

Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6
Time frame: Baseline, Week 6
100-millimeter (mm) Visual Analog Scale (VAS) score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Change from baseline of less than (<) 0 indicated improvement.
Participant's Assessment of Global Pain Intensity at Baseline
Time frame: Baseline
100-mm VAS scores specified participant's assessment of global pain intensity in the previous 48 hours, in response to the following question "What has been your global pain intensity in the last 48 hours?" 0=no pain to 100=worst pain. Lower scores indicated less pain.

24 secondary outcomes

Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4
Time frame: Baseline, Weeks 2, 4
Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6
Time frame: Baseline, Weeks 2, 4, 6
Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6
Time frame: Baseline, Weeks 2, 4, 6
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6
Time frame: Baseline, Weeks 2, 4, 6
Change From Baseline in BASFI at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6
Time frame: Baseline, Weeks 2, 4, 6
Change From Baseline in BASDAI at Week 12
Time frame: Baseline, Week 12
Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20
Time frame: Weeks 2, 4, 6, 12
Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6
Time frame: Baseline, Weeks 2, 4, 6
Change From Baseline in Nocturnal Pain at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6
Time frame: Baseline, Weeks 2, 4, 6
Change From Baseline in Fingertips to Floor Distance at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Chest Expansion at Weeks 2, 4, and 6
Time frame: Baseline, Weeks 2, 4, 6
Change From Baseline in Chest Expansion at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 6
Time frame: Baseline, Week 6
Change From Baseline in ESR at Week 12
Time frame: Baseline, Week 12
Change From Baseline in C-Reactive Protein (CRP) at Week 6
Time frame: Baseline, 6 Weeks
Change From Baseline in CRP at Week 12
Time frame: Baseline, Week 12
Percentage of Participants With Concomitant Use of Paracetamol
Time frame: Week 6
Percentage of Days With Concomitant Administration of Paracetamol
Time frame: Week 6
Paracetamol Tablets Taken Per Day by Participant
Time frame: Week 6

Results and safety

Results posted to the registry on 23 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Celecoxib 200 mg	120	113
Diclofenac SR 75 mg	120	110
Celecoxib 200 mg, Then Celecoxib 400 mg	0	0
Diclofenac SR 75 mg, Then Celecoxib 400 mg	0	0

Primary outcome: Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6

Time frame: Baseline, Week 6. Least squares mean (Standard Error). Unit: mm

Measure	Celecoxib 200 mg n = 111	Diclofenac SR 75 mg n = 108
Value	-23.8 (1.98)	-27.1 (2.02)

Celecoxib 200 mg vs Diclofenac SR 75 mg: LS Mean Difference: 3.3 (95% CI -2.2 to 8.8), p = 0.0085, ANCOVA

Population analysed: Per-Protocol (PP): All randomized participants who received at least one dose of study medication, and had global pain intensity assessment at Week 6 and no major protocol deviations.

Primary outcome: Participant's Assessment of Global Pain Intensity at Baseline

Time frame: Baseline. Mean (Standard Deviation). Unit: mm

Measure	Celecoxib 200 mg n = 111	Diclofenac SR 75 mg n = 108
Value	62.9 (12.68)	63.6 (13.38)

Population analysed: PP

24 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Celecoxib 200 mg	0 of 120 (0%)	11 of 120 (9.2%)	Not reported
Diclofenac SR 75 mg	0 of 120 (0%)	9 of 120 (7.5%)	Not reported
Celecoxib 200 mg, Then Celecoxib 200 mg	0 of 54 (0%)	0 of 54 (0%)	Not reported
Diclofenac SR 75 mg, Then Diclofenac SR 75 mg	0 of 55 (0%)	6 of 55 (10.9%)	Not reported
Celecoxib 200 mg, Then Celecoxib 400 mg	0 of 53 (0%)	5 of 53 (9.4%)	Not reported
Diclofenac SR 75 mg, Then Celecoxib 400 mg	0 of 54 (0%)	6 of 54 (11.1%)	Not reported

Limitations and caveats (from the sponsor): The protocol does not specify time points for secondary endpoints; these are described in the statistical analysis plan.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25516774Huang F, Gu J, Liu Y, Zhu P, Zheng Y, Fu J, Pan S, Le S. Efficacy and safety of celecoxib in chinese patients with ankylosing spondylitis: a 6-week randomized, double-blinded study with 6-week open-label extension treatment. Curr Ther Res Clin Exp. 2014 Dec 5;76:126-33. doi: 10.1016/j.curtheres.2014.08.002. eCollection 2014 Dec.
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

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Celecoxib and Diclofenac SR in people with Ankylosing Spondylitis, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 5 sites in China.

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 4 inclusion and 4 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 5 sites in China. 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 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?

Yes. Results are posted in the registry (first posted 23 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Participant's Assessment of Global Pain Intensity at Week 6 (time frame: Baseline, Week 6). 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 NCT00762463, 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 2 Feb 2021.