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Ulcerative ColitisPhase 3NCT00505778

A Comparison of Once a Day Dose Compared to 2 Doses/Day

A Phase 3 study testing Mesalamine Once-Daily and Mesalamine Twice-Daily in people with Ulcerative Colitis, run by Warner Chilcott at 245 sites in 3 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

The purpose of this study is to compare the efficacy in maintaining remission of ulcerative colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol dosing regimen. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
Mesalamine Once-Daily and Mesalamine Twice-Daily
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,027 participants
Where
245 sitesin 3 countries
Study dates
Jul 2007to Jul 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

  • Documented history of ulcerative colitis that has been successfully maintained in remission for at least 3 months prior to study entry
  • At least one flare in the past 18 months
  • Utilizing a stable maintenance dose of oral Asacol of 1.6 g/day up to 2.4 g/day (stable dose is defined as the same dose for the past 3 months)
  • Females must be postmenopausal or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception

Who cannot join

  • History of or current renal disease
  • History of hepatic disease
  • History of allergy or hypersensitivity to salicylates, aminosalicylates
  • Treatment with immunomodulatory therapy, biologic therapy or corticosteroids within 90 days of screening
  • Received any antidiarrheals, antispasmodics, or antibiotic within 1 month of screening

Trial locations and contacts

245 sites in 3 countries.

245 sites in 3 countries

United States233 sites

  • Research Facility

    Akron, Ohio, 44302

  • Research Facility

    Albuquerque, New Mexico, 87109

  • Research Facility

    Alexandria, Louisiana, 71301

  • Research Facility

    Alexandria, Virginia, 22306

  • Research Facility

    Allentown, Pennsylvania, 18104

  • Research Facility

    Amarillo, Texas, 79119

  • Research Facility

    Anaheim, California, 92801

  • Research Facility

    Anderson, Indiana, 46016

  • Research Facility

    Arlington Heights, Illinois, 60005

  • Research Facility

    Athens, Alabama, 35611

  • Research Facility

    Atlanta, Georgia, 30342-5000

  • Research Facility

    Aventura, Florida, 33180

  • Research Facility

    Babylon, New York, 11702

  • Research Facility

    Bangor, Maine, 04401

  • Research Facility

    Beaver Falls, Pennsylvania, 15010

  • Research Facility

    Berwyn, Illinois, 60402

  • Research Facility

    Beverly Hills, California, 90210

  • Research Facility

    Binghamton, New York, 13903

  • Research Facility

    Birmingham, Alabama, 35209

  • Research Facility

    Birmingham, Alabama, 35294

  • Research Facility

    Bismarck, North Dakota, 58501

  • Research Facility

    Bloomington, Indiana, 47403

  • Research Facility

    Boise, Idaho, 83704

  • Research Facility

    Boone, North Carolina, 28607

  • Research Facility

    Boston, Massachusetts, 02114

  • Research Facility

    Boston, Massachusetts, 02215

  • Research Facility

    Bowling Green, Kentucky, 42101

  • Research Facility

    Braintree, Massachusetts, 02184

  • Research Facility

    Brooklyn, New York, 11215

  • Research Facility

    Brooklyn, New York, 11234

  • Research Facility

    Camden, New Jersey, 08103

  • Research Facility

    Canton, Ohio, 44718

  • Research Facility

    Cape Girardeau, Missouri, 63703-6364

  • Research Facility

    Cedar Knolls, New Jersey, 07927

  • Research Facility

    Charlotte, North Carolina, 28204

  • Research Facility

    Cheektowaga, New York, 14225

  • Research Facility

    Chesapeake, Virginia, 23320

  • Research Facility

    Chesterfield, Michigan, 48047

  • Research Facility

    Chevy Chase, Maryland, 20815

  • Research Facility

    Chicago, Illinois, 60637

  • Research Facility

    Chico, California, 95926

  • Research Facility

    Cincinnati, Ohio, 45219

  • Research Facility

    Cincinnati, Ohio, 45242

  • Research Facility

    Clairton, Pennsylvania, 15025

  • Research Facility

    Cleveland, Ohio, 44195

  • Research Facility

    Clive, Iowa, 50325

  • Research Facility

    College Park, Maryland, 20740

  • Research Facility

    Columbia, Missouri, 65212

  • Research Facility

    Columbia, South Carolina, 29203

  • Research Facility

    Columbia, South Carolina, 29204

  • Research Facility

    Columbus, Georgia, 31904

  • Research Facility

    Cortland, New York, 13045

  • Research Facility

    Davenport, Iowa, 52807

  • Research Facility

    Dayton, Ohio, 45415

  • Research Facility

    Dayton, Ohio, 45440

  • Research Facility

    Decatur, Georgia, 30033

  • Research Facility

    Detroit, Michigan, 48201

  • Research Facility

    Dothan, Alabama, 26305-1156

  • Research Facility

    Egg Harbor, New Jersey, 08234-5857

  • Research Facility

    Elgin, Illinois, 60123

  • Research Facility

    Encinitas, California, 92024

  • Research Facility

    Englewood, Colorado, 80113

  • Research Facility

    Fairfax, Virginia, 22031

  • Research Facility

    Folsom, California, 95630

  • Research Facility

    Forest Hills, New York, 10128

  • Research Facility

    Fort Lauderdale, Florida, 33308

  • Research Facility

    Fort Worth, Texas, 76104

  • Research Facility

    Gainesville, Florida, 32607

  • Research Facility

    Garden City, New York, 11530

  • Research Facility

    Golden, Colorado, 80401

  • Research Facility

    Great Neck, New York, 11021

  • Research Facility

    Great Neck, New York, 11023

  • Research Facility

    Greenbelt, Maryland, 20770

  • Research Facility

    Greensboro, North Carolina, 27403

  • Research Facility

    Greenville, North Carolina, 27834

  • Research Facility

    Greenville, Texas, 75401

  • Research Facility

    Greer, South Carolina, 29651

  • Research Site

    Hackensack, New Jersey, 07601

  • Research Facility

    Hagerstown, Maryland, 21740

  • Research Facility

    Hartford, Connecticut, 06106

  • Research Facility

    Highland Park, Illinois, 60036

  • Research Facility

    Hoffman Estates, Illinois, 60169

  • Research Facility

    Hollywood, Florida, 33021

  • Research Facility

    Hollywood, Maryland, 20636

  • Research Facility

    Homewood, Illinois, 60430

  • Research Facility

    Houston, Texas, 77004

  • Research Facility

    Houston, Texas, 77054

  • Research Facility

    Houston, Texas, 77090

  • Research Facility

    Idaho Falls, Idaho, 83404

  • Research Facility

    Indiana, Pennsylvania, 15701

  • Research Facility

    Indianapolis, Indiana, 46202

  • Research Facility

    Indianapolis, Indiana, 46260

  • Research Facility

    Jackson, Tennessee, 38301

  • Research Facility

    Jackson, Tennessee, 38305

  • Research Facility

    Jacksonville, Florida, 32207

  • Research Facility

    Jacksonville, Florida, 32223

  • Research Facility

    Jacksonville, North Carolina, 28546

  • Research Facility

    Jefferson City, Missouri, 65109

  • Research Facility

    Kalamazoo, Michigan, 49048

  • Research Facility

    Kinston, North Carolina, 28501

  • Research Facility

    La Mesa, California, 91941

  • Research Facility

    Lafayette, Colorado, 80026

  • Research Facility

    Lafayette, Louisiana, 70503

  • Research Facility

    Lake Barrington, Illinois, 60010

  • Research Facility

    Lake Success, New York, 11042

  • Research Facility

    Lancaster, California, 93534

  • Research Facility

    Lancaster, Pennsylvania, 17604

  • Research Facility

    Largo, Florida, 33777

  • Research Facility

    Las Vegas, Nevada, 89147

  • Research Facility

    Lewisville, Texas, 75057

  • Research Facility

    Little Rock, Arkansas, 72205

  • Research Facility

    Long Beach, California, 90806

  • Research Facility

    Longview, Texas, 75605

  • Research Facility

    Los Angeles, California, 90015

  • Research Facility

    Los Angeles, California, 90045

  • Research Facility

    Louisville, Kentucky, 40202

  • Research Facility

    Louisville, Kentucky, 40291

  • Research Facility

    Lowell, Arkansas, 72745

  • Research Facility

    Lutherville, Maryland, 21093

  • Research Facility

    Madera, California, 93637

  • Research Facility

    Maitland, Florida, 32751

  • Research Facility

    Marietta, Georgia, 30060

  • Research Facility

    Marietta, Georgia, 30067

  • Research Facility

    Memphis, Tennessee, 38104

  • Research Facility

    Mentor, Ohio, 44060

  • Research Facility

    Merced, California, 95340

  • Research Facility

    Meriden, Connecticut, 06451

  • Research Facility

    Metairie, Louisiana, 70006

  • Research Facility

    Mexico, Missouri, 65265

  • Research Facility

    Milwaukee, Wisconsin, 53209

  • Research Facility

    Mission Hills, California, 91345

  • Research Facility

    Monroe, Louisiana, 71201

  • Research Facility

    Monroe, Wisconsin, 53566

  • Research Facility

    Monterey, California, 93940

  • Research Facility

    Morganton, North Carolina, 28655

  • Research Facility

    Morristown, Tennessee, 37814

  • Research Facility

    Mount Airy, North Carolina, 27030

  • Research Facility

    Murrieta, California, 92562

  • Research Facility

    Naples, Florida, 34102

  • Research Facility

    New Bern, North Carolina, 28562

  • Research Facility

    New Haven, Connecticut, 06510

  • Research Facility

    New Port Richey, Florida, 34652

  • Research Facility

    New York, New York, 10016

  • Research Facility

    New York, New York, 10028

  • Research Facility

    Newnan, Georgia, 30263

  • Research Facility

    Norfolk, Virginia, 23502

  • Research Facility

    North Miami Beach, Florida, 33162

  • Research Facility

    Norwalk, Connecticut, 06851

  • Research Facility

    Oak Lawn, Illinois, 60453

  • Research Facility

    Oakland, California, 94609

  • Research Facility

    Ocean City, New Jersey, 07712

  • Research Facility

    Odessa, Texas, 79761

  • Research Facility

    Ogden, Utah, 84405

  • Research Facility

    Orange, California, 92868

  • Research Facility

    Orlando, Florida, 32806

  • Research Facility

    Palm Harbor, Florida, 34684

  • Research Facility

    Palm Springs, California, 92262

  • Research Facility

    Pasadena, Texas, 77504

  • Research Facility

    Peoria, Illinois, 61602

  • Research Facility

    Philadelphia, Pennsylvania, 19106

  • Research Facility

    Phoenix, Arizona, 85050

  • Research Facility

    Phoenixville, Pennsylvania, 19460

  • Research Facility

    Pinehurst, North Carolina, 28374

  • Research Facility

    Pittsburgh, Pennsylvania, 15213

  • Research Facility

    Pittsburgh, Pennsylvania, 15243

  • Research Facility

    Pittsford, New York, 14534

  • Research Facility

    Plano, Texas, 75075

  • Research Facility

    Port Jefferson Station, New York, 11776

  • Research Facility

    Port Orange, Florida, 32129

  • Research Facility

    Portland, Oregon, 97225

  • Research Facility

    Pratt, Kansas, 67124

  • Research Facility

    Pueblo, Colorado, 81008

  • Research Facility

    Raleigh, North Carolina, 27607

  • Research Facility

    Reisterstown, Maryland, 21136

  • Research Facility

    Rochester, Minnesota, 55905

  • Research Facility

    Rochester, New York, 14621

  • Research Facility

    Rochester, New York, 14625

  • Research Facility

    Rockville, Maryland, 20850

  • Research Facility

    Rockville, Maryland, 20854

  • Research Facility

    Salt Lake City, Utah, 84107

  • Research Facility

    San Antonio, Texas, 78229

  • Research Facility

    San Carlos, California, 94070

  • Research Facility

    San Diego, California, 92103

  • Research Facility

    San Diego, California, 92117

  • Research Facility

    San Diego, California, 92123

  • Research Facility

    San Francisco, California, 94117

  • Research Facility

    San Francisco, California, 94122

  • Research Facility

    Savannah, Georgia, 31406

  • Research Facility

    Scottsdale, Arizona, 85259

  • Research Facility

    Seattle, Washington, 98133

  • Research Facility

    Sewickley, Pennsylvania, 15143

  • Research Facility

    Shreveport, Louisiana, 71103

  • Research Facility

    Somersworth, New Hampshire, 03878

  • Research Facility

    Souderton, Pennsylvania, 18964

  • Research Facility

    South Bend, Indiana, 46601

  • Research Facility

    South Plainfield, New Jersey, 07080

  • Research Facility

    Southbridge, Massachusetts, 01550

  • Research Facility

    Spokane, Washington, 99204

  • Research Facility

    St Louis, Missouri, 63128

  • Research Facility

    St. Petersburg, Florida, 33707

  • Research Facility

    St. Petersburg, Florida, 33711

  • Research Facility

    Tacoma, Washington, 98405

  • Research Facility

    Tallahassee, Florida, 32308

  • Research Facility

    Tampa, Florida, 33607

  • Research Facility

    Tampa, Florida, 33613

  • Research Facility

    Toledo, Ohio, 43617

  • Research Facility

    Topeka, Kansas, 66606

  • Research Facility

    Torrance, California, 90503

  • Research Facility

    Torrance, California, 90505

  • Research Facility

    Torrington, Connecticut, 06790

  • Research Facility

    Trinity, Florida, 34655

  • Research Facility

    Troy, Michigan, 48098

  • Research Facility

    Tucson, Arizona, 85712

  • Research Facility

    Tulsa, Oklahoma, 74104

  • Research Facility

    Tupelo, Mississippi, 38801

  • Research Facility

    Tuscon, Arizona, 85711

  • Research Facility

    Uniontown, Pennsylvania, 15401

  • Research Facility

    Upland, California, 91786

  • Research Facility

    Urbana, Illinois, 61801

  • Research Facility

    Virginia Beach, Virginia, 23454

  • Research Facility

    Warwick, Rhode Island, 02888

  • Research Facility

    Washington D.C., District of Columbia, 20060

  • Research Facility

    Waterloo, Iowa, 50701

  • Research Facility

    Wenatchee, Washington, 98801

  • Research Facility

    West Bloomfied, Michigan, 48322

  • Research Facility

    West Valley City, Utah, 84120

  • Research Facility

    Westlake, Ohio, 44145

  • Research Site

    Whichita, Kansas, 67214

  • Research Facility

    Wilmington, North Carolina, 28401

  • Research Facility

    Winchester, Virginia, 22601

  • Research Facility

    Winter Park, Florida, 32789

  • Research Facility

    Wyoming, Michigan, 49519

  • Research Facility

    Zephyrhills, Florida, 33542

Other trials in United States

Canada10 sites

  • Research Facility

    Abbotsford British Columbia, British Columbia, V2S 3N5

  • Research Facility

    Guelph, Ontario, N1H 3R3

  • Research Facility

    Hamilton, Ontario, L8N 4A6

  • Research Facility

    Montreal, Quebec, H1T 2M4

  • Research Facility

    Montreal, Quebec, H3T 1E2

  • Research Facility

    Ottawa, Ontario, K1H 8L6

  • Research Facility

    Québec, Quebec, G1L 3L5

  • Research Facility

    Québec, Quebec, G1S 4L8

  • Research Facility

    Toronto, Ontario, M4N 3M5

  • Research Facility

    Toronto, Ontario, M5G 2O4

Other trials in Canada

Puerto Rico2 sites

  • Research Facility

    Ponce, 00717

  • Research Facility

    San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: A Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Efficacy of 1.6 to 2.4 g Asacol® Therapy QD Versus Divided Dose (BID) in the Maintenance of Remission of Ulcerative Colitis

The purpose of this study is to compare the efficacy in maintaining remission of ulcerative colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol dosing regimen.

Read the detailed description

Currently, in the US, Asacol therapy is indicated in divided doses for the maintenance of remission of ulcerative colitis at 1.6 g/day. A once daily dose is potentially beneficial to patients and physicians alike. This study will answer the following questions about once daily dosing: (1) does efficacy differ between once daily and twice daily dosing, (2) do patients prefer a once daily dosing regimen, and (3) is compliance better? This study will confirm whether there are benefits to once daily dosing beyond increased convenience. In order to understand how the QD regimen compares to BID in a "real life" practice setting, the patient will remain on the total daily dose of Asacol (1.6 g/day to 2.4 g/day) on which they were maintained in remission, but will be assigned to either a QD or BID regimen. This is an investigator-blinded study.

Being tested
Mesalamine Once-Daily, Mesalamine Twice-Daily
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • Mesalamine Once-DailyDrug

    Also called Asacol QD

    Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks

  • Mesalamine Twice-DailyDrug

    Also called Asacol BID

    Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks

Study groups in NCT00505778
Study groupRoleWhat they receive
Mesalamine (Asacol) Once-DailyActive comparatoran oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
Receives: Drug: Mesalamine Once-Daily
Mesalamine (Asacol) Twice-DailyActive comparatoran oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
Receives: Drug: Mesalamine Twice-Daily

What is being measured

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

  1. Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI)

    Remission defined as SCCAI <5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).

    Measured: 6 months

Secondary outcomes (5)

  1. Percentage of Patients Remaining in Remission at Month 3, ITT Population

    Remission defined as SCCAI < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).

    Measured: 3 months

  2. Percentage of Patients Remaining in Remission at Month 12, ITT Population

    Remission defined as SCCAI score < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).

    Measured: 12 months

  3. Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population

    Relapse/flare is defined as SCCAI >= 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).

    Measured: 6 months

  4. Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6

    MARS: Composite score for the following statements: I change how many times per day I take my medicine, I forget to use it, I stop taking it for a while, I only use it when I am having active symptoms, I decide to miss out on a dose, I take less than instructed, I take more than instructed, I avoid using it if I can, I use it regularly every day (reverse scored): 5-never, 4-rarely, 3-sometimes, 2-often, 1-very often. Minimum score 9, maximum score 45.

    Measured: 6 months

  5. Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6

    Is your ulcerative colitis in remission (not active)? Y/N

    Measured: 6 months

Timeline

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

  1. First posted23 Jul 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionJul 2009
  4. Study completionJul 2009

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
1,027 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00505778
Sponsor's protocol ID
2007021
Status last verified
Apr 2013
First submitted
20 Jul 2007
Last updated
22 Apr 2013
Data monitoring committee
No

Publications

  • Sandborn WJ, Korzenik J, Lashner B, Leighton JA, Mahadevan U, Marion JF, Safdi M, Sninsky CA, Patel RM, Friedenberg KA, Dunnmon P, Ramsey D, Kane S. Once-daily dosing of delayed-release oral mesalamine (400-mg tablet) is as effective as twice-daily dosing for maintenance of remission of ulcerative colitis. Gastroenterology. 2010 Apr;138(4):1286-96, 1296.e1-3. doi: 10.1053/j.gastro.2009.12.054. Epub 2010 Jan 11.

    PubMed 20064514

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mesalamine Once-Daily and Mesalamine Twice-Daily in people with Ulcerative Colitis, run by Warner Chilcott at 245 sites in 3 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 4 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 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 245 sites in United States, Canada, Puerto Rico. 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 12 May 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?

Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI) (time frame: 6 months). 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 NCT00505778, 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 22 Apr 2013.

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