Osteoarthritis, KneePhase 4NCT00139776

Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"

A Phase 4 study testing Celecoxib in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 124 sites in 8 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

To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Osteoarthritis, Knee, Osteoarthritis, Hip
What is being tested?: Celecoxib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 875 participants
Where: 124 sitesin 8 countries
Study dates: Jul 2005to Feb 2008
Phase: Phase 4
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has been diagnosed, according to American College of Rheumatology guidelines, with osteoarthritis of the hip or knee and requires non-steroidal anti-inflammatory drugs (NSAIDs) to control their osteoarthritis pain and have access to a touch-tone telephone.

Who cannot join

Subject has had surgery on index joint.
Subject has history of rheumatoid arthritis or fibromyalgia syndrome.
Subject has active gastrointestinal or cardiovascular disease.

Trial locations and contacts

124 sites in 8 countries.

Country

City, postcode or hospital

124 sites in 8 countries

United States67 sites

Pfizer Investigational Site
Anaheim, California, 92801
Pfizer Investigational Site
Arlington, Virginia, 22205
Pfizer Investigational Site
Baltimore, Maryland, 21218
Pfizer Investigational Site
Beaver, Pennsylvania, 15009
Pfizer Investigational Site
Brockton, Massachusetts, 02301
Pfizer Investigational Site
Camp Hill, Pennsylvania, 17011
Pfizer Investigational Site
Cleveland, Ohio, 44122
Pfizer Investigational Site
Clinton, Maryland, 20735
Pfizer Investigational Site
Columbus, Ohio, 43210-1228
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Dallas, Texas, 75235
Pfizer Investigational Site
Danbury, Connecticut, 06810
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Dubuque, Iowa, 52001-7313
Pfizer Investigational Site
Dubuque, Iowa, 52002
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635-0909
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Frederick, Maryland, 21702
Pfizer Investigational Site
Great Neck, New York, 11021
Pfizer Investigational Site
Greenbelt, Maryland, 20770
Pfizer Investigational Site
Huntington Beach, California, 92646
Pfizer Investigational Site
Huntsville, Alabama, 35801
Pfizer Investigational Site
Jefferson City, Missouri, 65101
Pfizer Investigational Site
Jefferson City, Missouri, 65109
Pfizer Investigational Site
Johnson City, Tennessee, 37601
Pfizer Investigational Site
Johnstown, Pennsylvania, 15904
Pfizer Investigational Site
Knoxville, Tennessee, 37920
Pfizer Investigational Site
Las Vegas, Nevada, 89106
Pfizer Investigational Site
Las Vegas, Nevada, 89144
Pfizer Investigational Site
Lexington, Kentucky, 40509
Pfizer Investigational Site
Lincoln, Nebraska, 68516
Pfizer Investigational Site
Long Beach, California, 90806
Pfizer Investigational Site
Madisonville, Kentucky, 42431
Pfizer Investigational Site
Manlius, New York, 13104
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209
Pfizer Investigational Site
Mineola, New York, 11501
Pfizer Investigational Site
New Milford, Connecticut, 06776
Pfizer Investigational Site
New Tazewell, Tennessee, 37825
Pfizer Investigational Site
New York, New York, 10022-1009
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Omaha, Nebraska, 68134
Pfizer Investigational Site
Orange, California, 92868
Pfizer Investigational Site
Palm Harbor, Florida, 34684
Pfizer Investigational Site
Paramount, California, 90723
Pfizer Investigational Site
Peoria, Arizona, 85381
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19152
Pfizer Investigational Site
Phoenix, Arizona, 85051
Pfizer Investigational Site
Renton, Washington, 98055
Pfizer Investigational Site
Rochester, New York, 14609
Pfizer Investigational Site
South Miami, Florida, 33143
Pfizer Investigational Site
Springfield, Illinois, 62704
Pfizer Investigational Site
Springfield, Missouri, 65807
Pfizer Investigational Site
Stockton, California, 95204
Pfizer Investigational Site
Tacoma, Washington, 98405
Pfizer Investigational Site
Tampa, Florida, 33614-7118
Pfizer Investigational Site
Tustin, California, 92780
Pfizer Investigational Site
Walnut Creek, California, 94598
Pfizer Investigational Site
Waterbury, Connecticut, 06708
Pfizer Investigational Site
Wheat Ridge, Colorado, 80033
Pfizer Investigational Site
Wheaton, Maryland, 20902
Pfizer Investigational Site
Whittier, California, 90601
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103-4019
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Pfizer Investigational Site
Yakima, Washington, 98902-4876
Pfizer Investigational Site
Yakima, Washington, 98902
Pfizer Investigational Site
Zanesville, Ohio, 43701
Pfizer Investigational Site
Zephyrhills, Florida, 33542

Other trials in United States

Canada21 sites

Pfizer Investigational Site
Calgary, Alberta, T2S 2S7
Pfizer Investigational Site
Charlottetown, Prince Edward Island, C1A 5Y9
Pfizer Investigational Site
Corunna, Ontario, N0N 1G0
Pfizer Investigational Site
Hamilton, Ontario, L8M 1K7
Pfizer Investigational Site
London, Ontario, N6C 5J1
Pfizer Investigational Site
Mirabel, Quebec, J7J 2K8
Pfizer Investigational Site
Montague, Prince Edward Island, C0A 1R0
Pfizer Investigational Site
Montreal, Quebec, H4N 2W2
Pfizer Investigational Site
Newmarket, Ontario, L3Y 5G8
Pfizer Investigational Site
North York, Ontario, M3M 3E5
Pfizer Investigational Site
Rimouski, Quebec, G5L 9A8
Pfizer Investigational Site
Sarnia, Ontario, N7T 4X3
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 0H6
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 1Z1
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1A 3R5
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1E 2C2
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1E 2E2
Pfizer Investigational Site
Ste-Foy, Quebec, G1W 4R4
Pfizer Investigational Site
Toronto, Ontario, M9W 4L6
Pfizer Investigational Site
Vancouver, British Columbia, V5K 1K3
Pfizer Investigational Site
Windsor, Ontario, N8X 5A6

Other trials in Canada

United Kingdom19 sites

Pfizer Investigational Site
Bangor, BT19 1PP
Pfizer Investigational Site
Barry, Vale Of Glamorgan, CF62 7EB
Pfizer Investigational Site
Bath, BA2 4BY
Pfizer Investigational Site
Belfast, BT14 6AR
Pfizer Investigational Site
Blackpool, FY4 3AD
Pfizer Investigational Site
Bradford on Avon, Wiltshire, BA15 1DQ
Pfizer Investigational Site
Bradwell Common, Milton Keynes, MK13 8RN
Pfizer Investigational Site
Canterbury, Kent, CT1 3HX
Pfizer Investigational Site
Cardiff, CF24 2HP
Pfizer Investigational Site
Cookstown, BT80 8BG
Pfizer Investigational Site
Greenisland, Carrickfergus, Northern Ireland, BT38 8TP
Pfizer Investigational Site
Leslie, Fife, KY6 3LQ
Pfizer Investigational Site
Midsomer Norton, Wiltshire, BA3 2UH
Pfizer Investigational Site
Newtownabbey, Co.Antrim, BT37 9QN
Pfizer Investigational Site
Pound Hill, Crawley, West Sussex, RH10 7DX
Pfizer Investigational Site
Randalstown, Co Antrim, BT41 3AE
Pfizer Investigational Site
Trowbridge, BA14 9AR
Pfizer Investigational Site
Watford, Herts, WD25 0EA
Pfizer Investigational Site
Wigan, Lancs, WN6 9EP

Other trials in United Kingdom

Brazil4 sites

Pfizer Investigational Site
Campinas, São Paulo, 13073-350
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-903
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000
Pfizer Investigational Site
São Paulo, São Paulo, 04027-000

Other trials in Brazil

Colombia4 sites

Pfizer Investigational Site
Barranquila
Pfizer Investigational Site
Bogota, Cundinamarca
Pfizer Investigational Site
Bogotá
Pfizer Investigational Site
Bucaramanga

Other trials in Colombia

France4 sites

Pfizer Investigational Site
Joué-lès-Tours, 37300
Pfizer Investigational Site
L'Union, 31240
Pfizer Investigational Site
Poitiers, 86000
Pfizer Investigational Site
Tours, 37000

Other trials in France

Chile3 sites

Pfizer Investigational Site
Rancagua, Región del Libertador General Bernardo O’Higgins
Pfizer Investigational Site
Santiago, RM
Pfizer Investigational Site
Viña del Mar, Valparaiso

Other trials in Chile

Belgium2 sites

Pfizer Investigational Site
Ham, 3945
Pfizer Investigational Site
Liège, 4000

Other trials in Belgium

About this study

Official title: Double-Blind Parallel-Group Randomized Study Of Efficacy And Safety Of "Continuous Use" Of Celecoxib Vs. The "Usual Use" Of Celecoxib In The Treatment Of Subjects With Chronic Osteoarthritis Of The Hip Or Knee Who Require an Anti-inflammatory Medication for Control Of Their Pain

To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip.

Conditions: Osteoarthritis, Knee, Osteoarthritis, Hip
Being tested: Celecoxib
Keywords: Chronic treatment osteoarthritis, Celecoxib, Continuous Use, Intermittent Use
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis, Hip

What participants receive

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

CelecoxibDrug
24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind celecoxib 200 mg daily.
Placebo used as flare medication when directed.
CelecoxibDrug
24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind placebo daily.
Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Study groups in NCT00139776
Study group	Role	What they receive
Celecoxib - Continuous use	Active comparator	Not described Receives: Drug: Celecoxib
Celecoxib - Intermittent use	Active comparator	Not described Receives: Drug: Celecoxib

What is being measured

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

Number of Flare Events Per Time of Exposure to Study Medication
Number of flare events per month during Period III (calculated as number of flares divided by number of months participant was enrolled during Period III). Flare was determined using pre-defined criteria, using an interactive voice response system.
Measured: Period III (22 weeks)

Secondary outcomes (11)

Time to Occurrence of First Osteoarthritis (OA) Flare
Time from first dose of double blind medication (start of Period III) to occurrence of first OA flare. Flare was determined using pre-defined criteria, using an interactive voice response system
Measured: Period III (22 weeks)
Proportion of Days Free From Osteoarthritis (OA) Flare
Number of days subject was free from OA flare divided by number of days on study medication in Period III. Flare was determined using pre-defined criteria, using an interactive voice response system.
Measured: Period III (22 weeks)
Proportion of Days in Osteoarthritis (OA) Flare
Number of days subject was in OA flare divided by number of days on study medication in Period III. Subjects may have more than one flare. Flare was determined using pre-defined criteria, using an interactive voice response system.
Measured: Period III (22 weeks)
Arthritis Pain Numerical Rating Scale (NRS)
Participant rated intensity of osteoarthritis pain on categorical scale from 0 (no pain) to 10 (worst pain). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III.
Measured: Period III
Patient's Global Assessment of Arthritis
Participant's response to question "Considering all the ways the osteoarthritis in your hip or knee affects you, how are you doing today?" on scale from 1 (very good) to 5 (very poor). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III.
Measured: Period III
Physician's Global Assessment of Arthritis at Final Visit
Physician assessed each participant's disease symptoms on a categorical scale from 1 (very good) to 5 (very poor).
Measured: Period III (22 weeks)
Total Rescue Medication Taken (Mean)
Total amount of rescue medication (acetaminophen in milligrams [mg]) taken per month per participant
Measured: Period III (22 weeks)
Proportion of Days on Rescue Medication
Days on rescue medication divided by number of days on study medication in Period III
Measured: Period III (22 weeks)
Days on Flare Medication
Number of days on flare medication per month per subject calculated as number of days on flare medication divided by the number of days on study medication in Period III
Measured: Period III (22 weeks)
Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
Score at end of Period III minus score at start of Period III. WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Negative change indicates improvement.
Measured: Period III (22 weeks)
Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Scores analyzed as area under the curve (AUC) of participant's WOMAC scores from each assessment in Period III.
Measured: Period III (22 weeks)

Timeline

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

Jul 2005Feb 2008

First posted31 Aug 2005 (estimated)
Study startJul 2005
Primary completionFeb 2008
Study completionFeb 2008

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 Osteoarthritis, KneeStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 875 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00139776
Sponsor's protocol ID: A3191173
Status last verified: Mar 2021
First submitted: 29 Aug 2005
Last updated: 29 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Strand V, Simon LS, Dougados M, Sands GH, Bhadra P, Breazna A, Immitt J. Treatment of osteoarthritis with continuous versus intermittent celecoxib. J Rheumatol. 2011 Dec;38(12):2625-34. doi: 10.3899/jrheum.110636. Epub 2011 Nov 1.
PubMed 22045833

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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All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-Blind Parallel-Group Randomized Study Of Efficacy And Safety Of "Continuous Use" Of Celecoxib Vs. The "Usual Use" Of Celecoxib In The Treatment Of Subjects With Chronic Osteoarthritis Of The Hip Or Knee Who Require an Anti-inflammatory Medication for Control Of Their Pain
ClinicalTrials.gov ID: NCT00139776
Acronym / sponsor ID: A3191173
Conditions: Osteoarthritis, Knee, Osteoarthritis, Hip
Keywords: Chronic treatment osteoarthritis, Celecoxib, Continuous Use, Intermittent Use
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 875 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Jul 2005
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 31 Aug 2005 (estimated)
Results: Posted 19 May 2009

Clinical summary

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

To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Celecoxib - Continuous use	Active comparator	Drug: Celecoxib
Celecoxib - Intermittent use	Active comparator	Drug: Celecoxib

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subject has been diagnosed, according to American College of Rheumatology guidelines, with osteoarthritis of the hip or knee and requires non-steroidal anti-inflammatory drugs (NSAIDs) to control their osteoarthritis pain and have access to a touch-tone telephone.

Key exclusion criteria (3 listed)

Subject has had surgery on index joint.
Subject has history of rheumatoid arthritis or fibromyalgia syndrome.
Subject has active gastrointestinal or cardiovascular disease.

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
Celecoxib24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind celecoxib 200 mg daily. Placebo used as flare medication when directed.	Drug	Celecoxib - Continuous use
Celecoxib24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind placebo daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.	Drug	Celecoxib - Intermittent use

Primary outcome

Number of Flare Events Per Time of Exposure to Study Medication
Time frame: Period III (22 weeks)
Number of flare events per month during Period III (calculated as number of flares divided by number of months participant was enrolled during Period III). Flare was determined using pre-defined criteria, using an interactive voice response system.

11 secondary outcomes

Time to Occurrence of First Osteoarthritis (OA) Flare
Time frame: Period III (22 weeks)
Proportion of Days Free From Osteoarthritis (OA) Flare
Time frame: Period III (22 weeks)
Proportion of Days in Osteoarthritis (OA) Flare
Time frame: Period III (22 weeks)
Arthritis Pain Numerical Rating Scale (NRS)
Time frame: Period III
Patient's Global Assessment of Arthritis
Time frame: Period III
Physician's Global Assessment of Arthritis at Final Visit
Time frame: Period III (22 weeks)
Total Rescue Medication Taken (Mean)
Time frame: Period III (22 weeks)
Proportion of Days on Rescue Medication
Time frame: Period III (22 weeks)
Days on Flare Medication
Time frame: Period III (22 weeks)
Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
Time frame: Period III (22 weeks)
Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
Time frame: Period III (22 weeks)

Results and safety

Results posted to the registry on 19 May 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories	1,772	1,197
Open-Label Celecoxib Run-in Period	0	0
Celecoxib 200mg Continuous Use	0	0
Celecoxib 200mg Intermittent Use	0	0

Primary outcome: Number of Flare Events Per Time of Exposure to Study Medication

Time frame: Period III (22 weeks). Mean (Standard Deviation). Unit: flare events per month

Measure	Celecoxib 200mg Continuous Use n = 431	Celecoxib 200mg Intermittent Use n = 427
Value	0.54 (0.74)	0.93 (1.01)

Celecoxib 200mg Continuous Use vs Celecoxib 200mg Intermittent Use: p <0.0001, ANOVA

Population analysed: Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication

11 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 200mg Continuous Use	6 of ?	242 of ?	Not reported
Celecoxib 200mg Intermittent Use	10 of ?	246 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22045833Strand V, Simon LS, Dougados M, Sands GH, Bhadra P, Breazna A, Immitt J. Treatment of osteoarthritis with continuous versus intermittent celecoxib. J Rheumatol. 2011 Dec;38(12):2625-34. doi: 10.3899/jrheum.110636. Epub 2011 Nov 1.
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

124 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Celecoxib in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 124 sites in 8 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 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 29 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 124 sites in United States, Canada, United Kingdom, Brazil, Colombia and 3 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?

Yes. Results are posted in the registry (first posted 19 May 2009). 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?

Number of Flare Events Per Time of Exposure to Study Medication (time frame: Period III (22 weeks)). 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 NCT00139776, 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 29 Mar 2021.