AzTrials
AzTrials

Bipolar DisorderPhase 4NCT00067938

Bipolar Study in Adults at Least 18 Years of Age

A Phase 4 study testing lamotrigine in people with Bipolar Disorder, run by GlaxoSmithKline at 308 sites in United States.

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

Bipolar study of tolerability, clinical response and patient satisfaction Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bipolar Disorder
What is being tested?
lamotrigine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
308 sitesUnited States
Study dates
Aug 2003to Aug 2004
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of bipolar I disorder.
  • Must be on a stable regimen of psychiatric medication for at least 2 months prior to study.
  • If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception.

Who cannot join

  • Patients with a clinically significant psychiatric or physiologic comorbidity including significant substance abuse, depression or mania which is of an unstable of progressive nature that could interfere in participation of this study.
  • Presence of untreated thyroid disease.
  • Patient is actively suicidal or homicidal.
  • Patient has history of severe hepatic or renal insufficiency.
  • Patient is currently participating in another clinical trial.

Trial locations and contacts

308 sites in 1 country.

300 sites in 1 country

United States300 sites

  • GSK Investigational Site

    Adrian, Michigan, 49221

  • GSK Investigational Site

    Albany, New York, 31701

  • GSK Investigational Site

    Albertville, Alabama, 35950

  • GSK Investigational Site

    Albuquerque, New Mexico, 87108

  • GSK Investigational Site

    Altamonte Springs, Florida, 32714

  • GSK Investigational Site

    Alton, Illinois, 62002

  • GSK Investigational Site

    Amityville, New York, 11701

  • GSK Investigational Site

    Annapolis, Maryland, 21403

  • GSK Investigational Site

    Anniston, Alabama, 36207

  • GSK Investigational Site

    Arlington, Texas, 76012

  • GSK Investigational Site

    Arlington, Virginia, 22205

  • GSK Investigational Site

    Ashburn, Virginia, 20147

  • GSK Investigational Site

    Atlanta, Georgia, 30030

  • GSK Investigational Site

    Atlanta, Georgia, 30309-7520

  • GSK Investigational Site

    Atlanta, Georgia, 30338

  • GSK Investigational Site

    Austin, Texas, 78759

  • GSK Investigational Site

    Avon Lake, Ohio, 44012

  • GSK Investigational Site

    Bakersfield, California, 93309

  • GSK Investigational Site

    Baltimore, Maryland, 21239

  • GSK Investigational Site

    Batlimore, Maryland, 21208

  • GSK Investigational Site

    Baton Rouge, Louisiana, 70806

  • GSK Investigational Site

    Bay City, Michigan, 48706

  • GSK Investigational Site

    Bedford, Texas, 76022

  • GSK Investigational Site

    Bellingham, Washington, 98225

  • GSK Investigational Site

    Benton Harbor, Michigan, 49022

  • GSK Investigational Site

    Beverly Hills, California, 90210

  • GSK Investigational Site

    Billings, Montana, 59101

  • GSK Investigational Site

    Birmingham, Alabama, 35209

  • GSK Investigational Site

    Birmingham, Alabama, 35223

  • GSK Investigational Site

    Birmingham, Alabama, 35234

  • GSK Investigational Site

    Bloomfield Hills, Michigan, 48302

  • GSK Investigational Site

    Boca Raton, Florida, 33432

  • GSK Investigational Site

    Boca Raton, Florida, 33433

  • GSK Investigational Site

    Boise, Idaho, 83702

  • GSK Investigational Site

    Boise, Idaho, 83704

  • GSK Investigational Site

    Boise, Idaho, 83706

  • GSK Investigational Site

    Boulder, Colorado, 80303

  • GSK Investigational Site

    Bourbonnais, Illinois, 60914

  • GSK Investigational Site

    Boynton Beach, Florida, 33426

  • GSK Investigational Site

    Bradenton, Florida, 34209

  • GSK Investigational Site

    Brandon, Florida, 33511

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Brownstown Township, Michigan, 48183

  • GSK Investigational Site

    Burbank, California, 91501

  • GSK Investigational Site

    Burtonsville, Maryland, 20866

  • GSK Investigational Site

    Campbell, California, 95008

  • GSK Investigational Site

    Cary, North Carolina, 27511

  • GSK Investigational Site

    Casselberry, Florida, 32730

  • GSK Investigational Site

    Cedar Rapids, Iowa, 52402

  • GSK Investigational Site

    Cerritos, California, 90703

  • GSK Investigational Site

    Chandler, Arizona, 85225

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27514

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27517

  • GSK Investigational Site

    Charleston, South Carolina, 29407

  • GSK Investigational Site

    Charleston, West Virginia, 25301

  • GSK Investigational Site

    Charleston, West Virginia, 25309

  • GSK Investigational Site

    Charlotte, North Carolina, 28211

  • GSK Investigational Site

    Charlottesville, Virginia, 22903

  • GSK Investigational Site

    Charlottesville, Virginia, 22911

  • GSK Investigational Site

    Chicago, Illinois, 60657

  • GSK Investigational Site

    Christiansburg, Virginia, 24073

  • GSK Investigational Site

    Cincinnati, Ohio, 45206

  • GSK Investigational Site

    Cincinnati, Ohio, 45243

  • GSK Investigational Site

    Clearwater, Florida, 33764

  • GSK Investigational Site

    Clinton Township, Michigan, 48036

  • GSK Investigational Site

    Colmar, Pennsylvania, 18915

  • GSK Investigational Site

    Conroe, Texas, 77304

  • GSK Investigational Site

    Coral Springs, Florida, 33065

  • GSK Investigational Site

    Cordova, Tennessee, 38016

  • GSK Investigational Site

    Cornelius, North Carolina, 28031

  • GSK Investigational Site

    Cuyahoga Falls, Ohio, 44221

  • GSK Investigational Site

    Dallas, Texas, 75219

  • GSK Investigational Site

    Danville, Indiana, 46122

  • GSK Investigational Site

    Danville, Virginia, 24541

  • GSK Investigational Site

    Davie, Florida, 33024

  • GSK Investigational Site

    Dayton, Ohio, 45459

  • GSK Investigational Site

    Daytona Beach, Florida, 32114

  • GSK Investigational Site

    Decatur, Georgia, 30030

  • GSK Investigational Site

    Destin, Florida, 32541

  • GSK Investigational Site

    Doyletown, Pennsylvania, 18901

  • GSK Investigational Site

    Dubuque, Iowa, 52001

  • GSK Investigational Site

    Duluth, Minnesota, 55802

  • GSK Investigational Site

    Durham, North Carolina, 27705

  • GSK Investigational Site

    East Lansing, Michigan, 48823

  • GSK Investigational Site

    East Moline, Illinois, 61244

  • GSK Investigational Site

    El Centro, California, 92243

  • GSK Investigational Site

    Ellicott City, Maryland, 21043

  • GSK Investigational Site

    Evansville, Indiana, 47715

  • GSK Investigational Site

    Everett, Washington, 98201

  • GSK Investigational Site

    Evergreen Park, Illinois, 60805

  • GSK Investigational Site

    Fairfield, California, 94533

  • GSK Investigational Site

    Fairhope, Alabama, 36532

  • GSK Investigational Site

    Fairview Heights, Illinois, 62208

  • GSK Investigational Site

    Falls Church, Virginia, 22041

  • GSK Investigational Site

    Farmingdale, New York, 11735

  • GSK Investigational Site

    Farmington Hills, Michigan, 48334

  • GSK Investigational Site

    Fayetteville, North Carolina, 28305

  • GSK Investigational Site

    Flint, Michigan, 48507

  • GSK Investigational Site

    Flint, Michigan, 48532

  • GSK Investigational Site

    Flowood, Mississippi, 39232

  • GSK Investigational Site

    Forest City, North Carolina, 28043

  • GSK Investigational Site

    Fort Collins, Colorado, 80525

  • GSK Investigational Site

    Fort Smith, Arkansas, 72903

  • GSK Investigational Site

    Fort Walton Beach, Florida, 32548

  • GSK Investigational Site

    Fort Wayne, Indiana, 46805

  • GSK Investigational Site

    Gainesville, Florida, 32607

  • GSK Investigational Site

    Gaithersburg, Maryland, 20877

  • GSK Investigational Site

    Glen Burnie, Maryland, 21061

  • GSK Investigational Site

    Goldsboro, North Carolina, 27530

  • GSK Investigational Site

    Granite City, Illinois, 62040

  • GSK Investigational Site

    Greensboro, North Carolina, 27408

  • GSK Investigational Site

    Greenville, North Carolina, 27834

  • GSK Investigational Site

    Greenville, North Carolina, 27858

  • GSK Investigational Site

    Gulfport, Mississippi, 39503

  • GSK Investigational Site

    Hamden, Connecticut, 06514

  • GSK Investigational Site

    Henderson, Nevada, 89074

  • GSK Investigational Site

    High Point, North Carolina, 27262

  • GSK Investigational Site

    Hopkinsville, Kentucky, 42240

  • GSK Investigational Site

    Houma, Louisiana, 70360

  • GSK Investigational Site

    Houston, Texas, 77007

  • GSK Investigational Site

    Houston, Texas, 77014

  • GSK Investigational Site

    Houston, Texas, 77027

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Houston, Texas, 77042

  • GSK Investigational Site

    Houston, Texas, 77057

  • GSK Investigational Site

    Houston, Texas, 77074

  • GSK Investigational Site

    Humble, Texas, 77338

  • GSK Investigational Site

    Humble, Texas, 77339

  • GSK Investigational Site

    Huntsville, Alabama, 35802

  • GSK Investigational Site

    Irving, Texas, 75062

  • GSK Investigational Site

    Jacksonville, Florida, 32216

  • GSK Investigational Site

    Jacksonville, Florida, 32257

  • GSK Investigational Site

    Jacksonville Beach, Florida, 32250

  • GSK Investigational Site

    Johnson City, Tennessee, 37601

  • GSK Investigational Site

    Joliet, Illinois, 60435

  • GSK Investigational Site

    Joplin, Missouri, 64804

  • GSK Investigational Site

    Kansas City, Missouri, 64108

  • GSK Investigational Site

    Kingsport, Tennessee, 37664

  • GSK Investigational Site

    Kingston, Pennsylvania, 18704

  • GSK Investigational Site

    Kingwood, Texas, 77339

  • GSK Investigational Site

    Knoxville, Tennessee, 37919

  • GSK Investigational Site

    Knoxville, Tennessee, 37922

  • GSK Investigational Site

    La Mesa, California, 91941

  • GSK Investigational Site

    Lafayette, Indiana, 47904

  • GSK Investigational Site

    Laguna Hills, California, 92653

  • GSK Investigational Site

    Lake Charles, Louisiana, 70601

  • GSK Investigational Site

    Lakeland, Florida, 33803

  • GSK Investigational Site

    Las Cruces, New Mexico, 88011

  • GSK Investigational Site

    Las Vegas, Nevada, 89030

  • GSK Investigational Site

    Las Vegas, Nevada, 89102

  • GSK Investigational Site

    Latham, New York, 12110

  • GSK Investigational Site

    Laurel, Maryland, 20707

  • GSK Investigational Site

    Lawrenceville, Georgia, 30045

  • GSK Investigational Site

    Leavenworth, Kansas, 66048

  • GSK Investigational Site

    Lexington, Kentucky, 40509

  • GSK Investigational Site

    Libertyville, Illinois, 60048

  • GSK Investigational Site

    Lincoln, Nebraska, 68502

  • GSK Investigational Site

    Lisle, Illinois, 60532

  • GSK Investigational Site

    Little Rock, Arkansas, 72201

  • GSK Investigational Site

    Long Branch, New Jersey, 07740

  • GSK Investigational Site

    Los Angeles, California, 90011

  • GSK Investigational Site

    Los Angeles, California, 90089

  • GSK Investigational Site

    Macon, Georgia, 31201

  • GSK Investigational Site

    Madison, Tennessee, 37115

  • GSK Investigational Site

    Manchester, New Hampshire, 03104

  • GSK Investigational Site

    Mansfield Center, Connecticut, 06250

  • GSK Investigational Site

    McKeesport, Pennsylvania, 15132

  • GSK Investigational Site

    Media, Pennsylvania, 19063

  • GSK Investigational Site

    Mequion, Wisconsin, 53092

  • GSK Investigational Site

    Miami, Florida, 32216

  • GSK Investigational Site

    Miami, Florida, 33125

  • GSK Investigational Site

    Miami, Florida, 33157

  • GSK Investigational Site

    Miami, Florida, 33176

  • GSK Investigational Site

    Midlothian, Virginia, 23112

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53226

  • GSK Investigational Site

    Milwaukie, Oregon, 97222

  • GSK Investigational Site

    Minneapolis, Minnesota, 55454

  • GSK Investigational Site

    Mishawaka, Indiana, 46545

  • GSK Investigational Site

    Moncks Corner, South Carolina, 29461

  • GSK Investigational Site

    Mount Clemens, Michigan, 48043

  • GSK Investigational Site

    Murfreesboro, Tennessee, 37129

  • GSK Investigational Site

    Nacogdoches, Texas, 75965

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    Nashville, Tennessee, 37204

  • GSK Investigational Site

    Natrona Heights, Pennsylvania, 15065

  • GSK Investigational Site

    New Rochelle, New York, 10801

  • GSK Investigational Site

    New York, New York, 10023

  • GSK Investigational Site

    Newark, Delaware, 19713

  • GSK Investigational Site

    Newport News, Virginia, 23606

  • GSK Investigational Site

    Norfolk, Virginia, 23505

  • GSK Investigational Site

    North Charleston, South Carolina, 29406

  • GSK Investigational Site

    North Little Rock, Arkansas, 72113

  • GSK Investigational Site

    North Miami, Florida, 33161

  • GSK Investigational Site

    Norwich, Connecticut, 06360

  • GSK Investigational Site

    Oakbrook Terrace, Illinois, 60181

  • GSK Investigational Site

    Oakdale, Minnesota, 55128

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Ocala, Florida, 34474

  • GSK Investigational Site

    Oceanside, California, 92056

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73103

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73109

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73118

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73120

  • GSK Investigational Site

    Olean, New York, 14760

  • GSK Investigational Site

    Omaha, Nebraska, 68124

  • GSK Investigational Site

    Omaha, Nebraska, 68131

  • GSK Investigational Site

    Orange City, Florida, 32763

  • GSK Investigational Site

    Orland Park, Illinois, 60462

  • GSK Investigational Site

    Orlando, Florida, 32803

  • GSK Investigational Site

    Overland Park, Kansas, 66211

  • GSK Investigational Site

    Palm Beach Gardens, Florida, 33410

  • GSK Investigational Site

    Park Ridge, Illinois, 60068

  • GSK Investigational Site

    Pensacola, Florida, 32503

  • GSK Investigational Site

    Petaluma, California, 94952

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19139

  • GSK Investigational Site

    Phoenix, Arizona, 85004

  • GSK Investigational Site

    Phoenix, Arizona, 85018

  • GSK Investigational Site

    Phoenix, Arizona, 85032

  • GSK Investigational Site

    Phoenix, Arizona, 85044

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15243

  • GSK Investigational Site

    Plantation, Florida, 33324

  • GSK Investigational Site

    Plymouth, Indiana, 46563

  • GSK Investigational Site

    Port Jefferson, New York, 11777

  • GSK Investigational Site

    Portland, Oregon, 97210

  • GSK Investigational Site

    Portsmouth, Virginia, 23703

  • GSK Investigational Site

    Poway, California, 92064

  • GSK Investigational Site

    Princeton, New Jersey, 08540

  • GSK Investigational Site

    Racine, Wisconsin, 53403

  • GSK Investigational Site

    Raleigh, North Carolina, 27605

  • GSK Investigational Site

    Raleigh, North Carolina, 27607

  • GSK Investigational Site

    Raleigh, North Carolina, 27609

  • GSK Investigational Site

    Raleigh, North Carolina, 27612

  • GSK Investigational Site

    Reading, Pennsylvania, 19610

  • GSK Investigational Site

    Renton, Washington, 98055

  • GSK Investigational Site

    Richmond, Virginia, 23230

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Rochester Hills, Michigan, 48307

  • GSK Investigational Site

    Rockford, Illinois, 61108

  • GSK Investigational Site

    Rockville, Maryland, 20852

  • GSK Investigational Site

    Rogers, Arizona, 72756

  • GSK Investigational Site

    Roswell, Georgia, 30075

  • GSK Investigational Site

    Royal Oak, Michigan, 48067

  • GSK Investigational Site

    Sacramento, California, 95825

  • GSK Investigational Site

    Saint Charles, Missouri, 63301

  • GSK Investigational Site

    Salt Lake City, Utah, 84102

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Antonio, Texas, 78232

  • GSK Investigational Site

    San Diego, California, 92103

  • GSK Investigational Site

    San Diego, California, 92114

  • GSK Investigational Site

    San Diego, California, 92123

  • GSK Investigational Site

    San Jose, California, 95123

  • GSK Investigational Site

    Santa Ana, California, 92705

  • GSK Investigational Site

    Santa Barbara, California, 93102

  • GSK Investigational Site

    Sarasota, Florida, 34238

  • GSK Investigational Site

    Schaumburg, Illinois, 60194

  • GSK Investigational Site

    Shawnee Mission, Kansas, 66214

  • GSK Investigational Site

    Sherman Oaks, California, 91403

  • GSK Investigational Site

    Shreveport, Louisiana, 71101

  • GSK Investigational Site

    Smithtown, New York, 11787

  • GSK Investigational Site

    Spokane, Washington, 99204

  • GSK Investigational Site

    Springfield, Missouri, 65804

  • GSK Investigational Site

    St Louis, Missouri, 63117

  • GSK Investigational Site

    St Louis, Missouri, 63128

  • GSK Investigational Site

    St Louis, Missouri, 63136-3675

  • GSK Investigational Site

    St. Petersburg, Florida, 33701

  • GSK Investigational Site

    St. Petersburg, Florida, 33702

  • GSK Investigational Site

    Stockbridge, Georgia, 30281

  • GSK Investigational Site

    Suffolk, Virginia, 23434

  • GSK Investigational Site

    Sugar Land, Texas, 77478

  • GSK Investigational Site

    Syracuse, Florida, 13202

  • GSK Investigational Site

    Tacoma, Washington, 98499

  • GSK Investigational Site

    Tampa, Florida, 33603

  • GSK Investigational Site

    The Bronx, New York, 10461

  • GSK Investigational Site

    Topeka, Kansas, 66606

  • GSK Investigational Site

    Torrance, California, 90505

  • GSK Investigational Site

    Towson, Maryland, 21204

  • GSK Investigational Site

    Towson, Maryland, 21286

  • GSK Investigational Site

    Tucson, Arizona, 85719

  • GSK Investigational Site

    Tulsa, Oklahoma, 74120

  • GSK Investigational Site

    Tulsa, Oklahoma, 74136

  • GSK Investigational Site

    Tuscaloosa, Alabama, 35404

  • GSK Investigational Site

    Tyler, Texas, 75702

  • GSK Investigational Site

    Valparaiso, Indiana, 46383

  • GSK Investigational Site

    Vernon Hills, Illinois, 60061

  • GSK Investigational Site

    Virginia Beach, Virginia, 23452

  • GSK Investigational Site

    Warner Robins, Georgia, 31093

  • GSK Investigational Site

    Warren, Ohio, 44483

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20011

  • GSK Investigational Site

    Waukesha, Wisconsin, 53188

  • GSK Investigational Site

    Wauwatosa, Wisconsin, 53213

  • GSK Investigational Site

    Weirton, West Virginia, 26062

  • GSK Investigational Site

    West Allis, Wisconsin, 53227

  • GSK Investigational Site

    West Hollywood, California, 90048

  • GSK Investigational Site

    West Palm Beach, Florida, 33407

  • GSK Investigational Site

    Wethersfield, Connecticut, 06109

  • GSK Investigational Site

    Wheaton, Illinois, 60187

  • GSK Investigational Site

    Wichita, Kansas, 67205

  • GSK Investigational Site

    Wichita, Kansas, 67206

  • GSK Investigational Site

    Wichita, Kansas, 67207

  • GSK Investigational Site

    Wichita, Kansas, 67211

Other trials in United States

About this study

Official title: Lamictal for Use in Treatment of Bipolar Disorder In Adults. A Practical Clinical Assessment of Tolerability and Clinical Effectiveness.

Bipolar study of tolerability, clinical response and patient satisfaction

Being tested
lamotrigine
Keywords
bipolar disorder, lamotrigine
Medical subject headings
Bipolar Disorder

What participants receive

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

  • lamotrigineDrug

    Lamotrigine

Study groups in NCT00067938
Study groupRoleWhat they receive
Arm 1OtherOpen label single arm study
Receives: Drug: lamotrigine

What is being measured

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

  1. The primary endpoint will be the rate of rash during 12 weeks.

    Measured: 12 Weeks

Secondary outcomes (1)

  1. Change from baseline in Week 5 and Week 12 Clinical Global Impression-Bipolar version (CGI-BP) Severityand Improvement scores.

    Measured: 12 Weeks

Timeline

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

  1. First posted5 Sep 2003 (estimated)
  2. Study startAug 2003
  3. Primary completionAug 2004
  4. Study completionAug 2004

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00067938
Sponsor's protocol ID
SCA40917
Status last verified
Aug 2016
First submitted
3 Sep 2003
Last updated
1 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing lamotrigine in people with Bipolar Disorder, run by GlaxoSmithKline at 308 sites in United States.

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 5 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 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 308 sites in United States. 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?

The primary endpoint will be the rate of rash during 12 weeks. (time frame: 12 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 NCT00067938.

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 1 Sep 2016.

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