Arthritis, GoutyPhase 3NCT00549549

Celebrex In Acute Gouty Arthritis Study

A Phase 3 study testing Indomethacin and Celecoxib in people with Arthritis, Gouty, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 81 sites in 12 countries.

Completed

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

Official record

Search all trials

Trial summary

This is a multicenter, double-blind, double-dummy, randomized, active-controlled study that will include an 8-day treatment period followed by a 1-week follow-up period in patients experiencing symptoms of an acute exacerbation of gouty arthritis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthritis, Gouty
What is being tested?: Indomethacin and Celecoxib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 402 participants
Where: 81 sitesin 12 countries
Study dates: Feb 2008to Dec 2009
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Acute gouty arthritis meeting the American College of Rheumatology (ACR) criteria for acute arthritis of primary gout;
Onset of pain from an acute gouty arthritis attack within 48 hours prior to Screening/Baseline (Visit 1);
A rating of moderate, severe, or extreme (2, 3, or 4, respectively) on the Patient's assessment of pain intensity in the index joint (5-point scale:0-4) at Screening/Baseline.

Who cannot join

Diagnosis of any other type of arthritis including those types suspected of being infectious in origin in the index joint or presence of any acute trauma of the index joint. Patients with osteoarthritis will be included as long as it is mild or moderate (according to investigator's criteria) and it does not affect the index joint;
Acute polyarticular gout involving greater than 4 joints or chronic gout.

Trial locations and contacts

81 sites in 12 countries.

Country

City, postcode or hospital

81 sites in 12 countries

United States43 sites

Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Beaumont, Texas, 77701
Pfizer Investigational Site
Beaumont, Texas, 77706
Pfizer Investigational Site
Bryan, Texas, 77802
Pfizer Investigational Site
Chaska, Minnesota, 55318
Pfizer Investigational Site
Columbia, Missouri, 65203
Pfizer Investigational Site
Columbus, Missouri, 65212
Pfizer Investigational Site
Dallas, Texas, 75235
Pfizer Investigational Site
DeLand, Florida, 32720
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635
Pfizer Investigational Site
Dunwoody, Georgia, 30338
Pfizer Investigational Site
Gainesville, Florida, 32607
Pfizer Investigational Site
Glendale, Arizona, 85304
Pfizer Investigational Site
Havertown, Pennsylvania, 19083
Pfizer Investigational Site
Lansing, Michigan, 48910-8595
Pfizer Investigational Site
Lexington, Kentucky, 40504
Pfizer Investigational Site
Longmont, Colorado, 80501
Pfizer Investigational Site
Lyndhurst, Ohio, 44124
Pfizer Investigational Site
Mesa, Arizona, 85202
Pfizer Investigational Site
Milwaukee, Wisconsin, 53295
Pfizer Investigational Site
Mineola, New York, 11501
Pfizer Investigational Site
Mount Sterling, Kentucky, 40353
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
New Tazewell, Tennessee, 37825
Pfizer Investigational Site
Northglenn, Colorado, 80234
Pfizer Investigational Site
Omaha, Nebraska, 68134
Pfizer Investigational Site
Paradise Valley, Arizona, 85253
Pfizer Investigational Site
Peoria, Arizona, 85381
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Rockford, Illinois, 61107
Pfizer Investigational Site
Roseville, California, 95661
Pfizer Investigational Site
San Antonio, Texas, 78217
Pfizer Investigational Site
San Antonio, Texas, 78224
Pfizer Investigational Site
San Diego, California, 92103-6204
Pfizer Investigational Site
San Luis Obispo, California, 93405
Pfizer Investigational Site
Shreveport, Louisiana, 71105-5634
Pfizer Investigational Site
Shreveport, Louisiana, 71106
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Statesville, North Carolina, 28625
Pfizer Investigational Site
Tampa, Florida, 33606
Pfizer Investigational Site
Tyler, Texas, 75701
Pfizer Investigational Site
Wheaton, Maryland, 20902
Pfizer Investigational Site
Willoughby Hills, Ohio, 44094

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Canada9 sites

Pfizer Investigational Site
Corunna, Ontario, N0N 1G0
Pfizer Investigational Site
Langley, British Columbia, V3A 4H9
Pfizer Investigational Site
Québec, Quebec, G1W 4R4
Pfizer Investigational Site
Sarnia, Ontario, N7T 4X3
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 7H9
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1A 3R5
Pfizer Investigational Site
Toronto, Ontario, M3M 3E5
Pfizer Investigational Site
Windsor, Ontario, N8X 5A6
Pfizer Investigational Site
Winnipeg, Manitoba, R2V 4W3

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Philippines6 sites

Pfizer Investigational Site
Las Piñas, 1742
Pfizer Investigational Site
Lipa City, Batangas, 4217
Pfizer Investigational Site
Manila, 1000
Pfizer Investigational Site
Manila, 1003
Pfizer Investigational Site
Manila, 1008
Pfizer Investigational Site
Quezon City, 1102

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Russia4 sites

Pfizer Investigational Site
Moscow, 115522
Pfizer Investigational Site
Petrozavodsk, 185019
Pfizer Investigational Site
Saint Petersburg, 193015
Pfizer Investigational Site
Saint Petersburg, 194291

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Colombia3 sites

Pfizer Investigational Site
Barranquilla, Atlántico, 0000
Pfizer Investigational Site
Barranquilla, Atlántico, 0
Pfizer Investigational Site
Bucaramanga, Santander Department

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Mexico3 sites

Pfizer Investigational Site
Guadalajara, Jalisco, 44100
Pfizer Investigational Site
México, D.F., 06726
Pfizer Investigational Site
Mexico City, Mexico City, 06700

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Peru3 sites

Pfizer Investigational Site
Lima, 11
Pfizer Investigational Site
Lima, 34
Pfizer Investigational Site
Lima, L27

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Taiwan3 sites

Pfizer Investigational Site
Hualien City, 970
Pfizer Investigational Site
Taichung, 404
Pfizer Investigational Site
Taipei, 106

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Costa Rica2 sites

Pfizer Investigational Site
Cartago
Pfizer Investigational Site
Heredia

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South Korea2 sites

Pfizer Investigational Site
Daegu, 705-718
Pfizer Investigational Site
Suwon, Kyeongki-do, 443-721

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Thailand2 sites

Pfizer Investigational Site
Khon Kaen, 40002
Pfizer Investigational Site
Phayathai, Bangkok, 10400

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Spain1 site

Pfizer Investigational Site
Seville, 41014

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About this study

Official title: A Phase 3, Randomized, Double-Blind, Multicenter, Active-Controlled Trial To Evaluate The Efficacy And Safety Of Celecoxib (Celebrex®) And Indomethacin In The Treatment Of Moderate To Severe Acute Gouty Arthritis

Conditions: Arthritis, Gouty
Being tested: Indomethacin, Celecoxib
Medical subject headings: Arthritis, Gouty

What participants receive

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

IndomethacinDrug
indomethacin 50 mg three times a day (TID) for 8 days.
CelecoxibDrug
An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg two times a day (BID) for 7 days.
CelecoxibDrug
An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later (celecoxib 400/200 mg regimen) and continuing 200 mg two times a day (BID) for 7 days.
CelecoxibDrug
Celecoxib 50 mg two times a day (BID) for 8 days

Study groups in NCT00549549
Study group	Role	What they receive
1	Active comparator	Not described Receives: Drug: Indomethacin
2	Experimental	Not described Receives: Drug: Celecoxib
3	Experimental	Not described Receives: Drug: Celecoxib
4	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 to Day 2 in Patient's Assessment of Pain Intensity
The Patient's Pain Intensity in the Index Joint for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate (2), Severe (3), or Extreme (4).
Measured: Baseline and Day 2

Secondary outcomes (14)

Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness
Tenderness was assessed on the basis of palpation or passive motion using a 4 point scale with the following ratings: the patient had no tenderness (0), the patient complained of pain (1), the patient complained of pain and winced (2) and the patient complained of pain, winced, and withdrew (3).
Measured: Baseline, Day 5, Day 9, and Day 14/Early Termination
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling
Swelling was assessed using a 4 point scale with the following ratings: none (0), palpable (1), visible (2), and bulging beyond joint margins (3)
Measured: Baseline, Days 5, 9 and 14/Early Termination
Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination
Redness was assessed by the physician as present or absent.
Measured: Baseline, Day 5, Day 9 and Day 14/Early Termination
Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14
Warmth was assessed by the physician as present or absent.
Measured: Baseline, Day 5, Day 9 and Day 14
Change From Baseline in Patient's Assessment of Pain Intensity
The Patient's assessment of pain for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).
Measured: Baseline, Day 2 to Day 13
Change From Baseline in Patient's Assessment of Pain Intensity on Day 1
The patient's assessment of pain was assessed by completion of the following 5 point scale: my pain at this time is none (0), mild (1), moderate, (2), severe (3), and extreme (4).
Measured: Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose)
Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours
Time weighted average over 8 (TWA-8), 12 (TWA-12) and 24 (TWA-24) hours post first dose of study medication on Day 1. Positive TWA values represent a reduction in pain intensity
Measured: Baseline, 8, 12, and 24 hours post first dose
Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity
The Patient's assessment of pain was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).
Measured: Baseline, Day 2
Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline
The participant's assessment of pain was assessed by completion of the following 5 point scale: My pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4).
Measured: Baseline
Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13
The participant's assessment of pain was assessed by completion of the following 5 point scale: My change in pain has been: None (0), Mild (1), Moderate, (2), Severe (3), and Extreme (4). Average change over days was calculated by taking the change from Baseline to the average Pain Intensity score over the days for each patient.
Measured: Baseline to Day 13
Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy
Withdrawal due to lack of efficacy was assessed from Days 1 to 8
Measured: Day 1 to Day 8
Participants Global Evaluation of Study Medication Score
The participant rated the study medication that they received during the study by completing the following question:
How would you rate the study medication you received for pain? 4=Excellent, 3=Good, 2=Fair, 1=Poor
Measured: Day 9
Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events
The gastrointestinal tolerability was measured by incidence of moderate or severe GI adverse events (nausea, abdominal pain and dyspepsia)
Measured: Baseline to Day 14/Early Termination
Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events
The pre-specfied CNS AEs were headache, nausea, dizziness, vertigo, vomiting and somnolence.
Measured: Baseline to Day 14/Early Termination

Timeline

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

Feb 2008Dec 2009

First posted26 Oct 2007 (estimated)
Study startFeb 2008
Primary completionDec 2009
Study completionDec 2009

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 Arthritis, GoutyStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 402 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00549549
Sponsor's protocol ID: A3191219
Status last verified: Feb 2021
First submitted: 24 Oct 2007
Last updated: 21 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother. 2011 Oct;9(5):271-85. doi: 10.1016/j.amjopharm.2011.07.004. Epub 2011 Aug 17.
PubMed 21849262

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 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-Blind, Multicenter, Active-Controlled Trial To Evaluate The Efficacy And Safety Of Celecoxib (Celebrex®) And Indomethacin In The Treatment Of Moderate To Severe Acute Gouty Arthritis
ClinicalTrials.gov ID: NCT00549549
Acronym / sponsor ID: A3191219
Conditions: Arthritis, Gouty
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 402 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 26 Oct 2007 (estimated)
Results: Posted 24 Feb 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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1	Active comparator	Drug: Indomethacin
2	Experimental	Drug: Celecoxib
3	Experimental	Drug: Celecoxib
4	Experimental	Drug: Celecoxib

Who may qualify

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

Key inclusion criteria (3 listed)

Acute gouty arthritis meeting the American College of Rheumatology (ACR) criteria for acute arthritis of primary gout;
Onset of pain from an acute gouty arthritis attack within 48 hours prior to Screening/Baseline (Visit 1);
A rating of moderate, severe, or extreme (2, 3, or 4, respectively) on the Patient's assessment of pain intensity in the index joint (5-point scale:0-4) at Screening/Baseline.

Key exclusion criteria (2 listed)

Diagnosis of any other type of arthritis including those types suspected of being infectious in origin in the index joint or presence of any acute trauma of the index joint. Patients with osteoarthritis will be included as long as it is mild or moderate (according to investigator's criteria) and it does not affect the index joint;
Acute polyarticular gout involving greater than 4 joints or chronic gout.

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
Indomethacinindomethacin 50 mg three times a day (TID) for 8 days.	Drug	1
CelecoxibAn initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg two times a day (BID) for 7 days.	Drug	2
CelecoxibAn initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later (celecoxib 400/200 mg regimen) and continuing 200 mg two times a day (BID) for 7 days.	Drug	3
CelecoxibCelecoxib 50 mg two times a day (BID) for 8 days	Drug	4

Primary outcome

Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity
Time frame: Baseline and Day 2
The Patient's Pain Intensity in the Index Joint for the prior 24 hours was assessed by completion of the following 5 point scale: My pain over the past 24 hours has been: None (0), Mild (1), Moderate (2), Severe (3), or Extreme (4).

14 secondary outcomes

Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Tenderness
Time frame: Baseline, Day 5, Day 9, and Day 14/Early Termination
Change From Baseline in Physician's Assessment of the Index Joint on Days 5, 9, and 14/Early Termination: Swelling
Time frame: Baseline, Days 5, 9 and 14/Early Termination
Number of Participants With Redness Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14/Early Termination
Time frame: Baseline, Day 5, Day 9 and Day 14/Early Termination
Number of Participants With Warmth Present According to Physician's Assessment of the Index Joint on Day 5, Day 9, and Day 14
Time frame: Baseline, Day 5, Day 9 and Day 14
Change From Baseline in Patient's Assessment of Pain Intensity
Time frame: Baseline, Day 2 to Day 13
Change From Baseline in Patient's Assessment of Pain Intensity on Day 1
Time frame: Baseline, 2, 4, 8, 12 hours postdose Day 1, Day 2 (24 hours and 32 hours post first dose)
Change From Baseline in Time Weighted Average of Patient's Assessment of Pain Intensity Over 8, 12, and 24 Hours
Time frame: Baseline, 8, 12, and 24 hours post first dose
Number of Participants With ≥30% and ≥50% Reduction From Baseline to Day 2 in Patient's Assessment of Pain Intensity
Time frame: Baseline, Day 2
Participant's Assessment of Pain Intensity for the Average Pain Intensity at Baseline
Time frame: Baseline
Percentage Change From Baseline in the Patient's Assessment of Pain Intensity for the Average Pain Intensity on Days 2-4, Days 2-8 and Days 2-13
Time frame: Baseline to Day 13
Number of Participants With Withdrawal From Treatment Due to Lack of Efficacy
Time frame: Day 1 to Day 8
Participants Global Evaluation of Study Medication Score
Time frame: Day 9
Number of Participants With Pre-specified Gastrointestinal (GI) Adverse Events
Time frame: Baseline to Day 14/Early Termination
Number of Participants With Moderate or Severe Central Nervous System (CNS) Adverse Events
Time frame: Baseline to Day 14/Early Termination

Results and safety

Results posted to the registry on 24 Feb 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 50 mg	101	77
Celecoxib 400/200 mg	99	77
Celecoxib 800/400 mg	99	82
Indomethacin 50 mg	103	78

Primary outcome: Change From Baseline to Day 2 in Patient's Assessment of Pain Intensity

Time frame: Baseline and Day 2. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Celecoxib 50 mg n = 100	Celecoxib 400/200 mg n = 99	Celecoxib 800/400 mg n = 96	Indomethacin 50 mg n = 102
Baseline	3.03 (0.67)	2.73 (0.62)	2.84 (0.69)	2.83 (0.76)
Change at Day 2	-1.14 (1.10)	-1.23 (0.97)	-1.51 (1.11)	-1.62 (0.97)

Celecoxib 50 mg vs Celecoxib 800/400 mg: Median Difference (Final Values): -0.46 (95% CI -0.74 to -0.18), ANCOVA
Celecoxib 50 mg vs Celecoxib 400/200 mg: Median Difference (Final Values): -0.24 (95% CI -0.52 to 0.04), ANCOVA
Celecoxib 50 mg vs Indomethacin 50 mg: Mean Difference (Final Values): 0.57 (95% CI 0.29 to 0.84), ANCOVA

Population analysed: Intent to treat (ITT): defined to be all subjects who were randomized, took at least 1 dose of study medication and had at least one post baseline evaluation; and Last Observation Carried Forward (LOCF)

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Celecoxib 50 mg	0 of 101 (0%)	22 of 101 (21.8%)	Not reported
Celecoxib 400/200 mg	0 of 99 (0%)	22 of 99 (22.2%)	Not reported
Celecoxib 800/400 mg	0 of 98 (0%)	21 of 98 (21.4%)	Not reported
Indomethacin 50 mg	1 of 102 (1%)	32 of 102 (31.4%)	Not reported

Limitations and caveats (from the sponsor): Patients Global Evaluation of study medication data was collected at Day 9 only.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21849262Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother. 2011 Oct;9(5):271-85. doi: 10.1016/j.amjopharm.2011.07.004. Epub 2011 Aug 17.
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

81 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Indomethacin and Celecoxib in people with Arthritis, Gouty, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 81 sites in 12 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 2 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 21 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 81 sites in United States, Canada, Philippines, Russia, Colombia and 7 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 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 24 Feb 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 to Day 2 in Patient's Assessment of Pain Intensity (time frame: Baseline and Day 2). 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 NCT00549549, 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 21 Feb 2021.