A Comparison of Once a Day Dose Compared to 2 Doses/Day - Full Text View

Sponsored by:	Procter and Gamble
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00505778

Purpose

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.

Condition	Intervention	Phase
Ulcerative Colitis	Drug: Asacol	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy 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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Mesalamine

U.S. FDA Resources

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

The primary outcome will be the proportion of patients remaining in remission for each treatment group as determined by the Simple Clinical Colitis Activity Index (SCCAI) at Month 6 [ Time Frame: At 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to relapse/flare measured from baseline to diagnosis of relapse/flare; percentage of patients who remain in remission at Months 3 and 12; adherence to dosing regimen; patient satisfaction with treatment and dosing regimen [ Time Frame: At 3 and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator an oral, once daily (QD) Asacol regimen (1.6g/day to 2.4g/day)	Drug: Asacol an oral, once daily (QD) Asacol regimen (1.6g/day to 2.4g/day
1: Active Comparator an oral, twice daily Asacol regimen (1.6g/day to 2.4g/day)	Drug: Asacol an oral, twice daily Asacol regimen (1.6g/day to 2.4g/day)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505778

Show 211 Study Locations

Sponsors and Collaborators

Procter and Gamble

Investigators

Study Director:

Tom G Todaro, MD

Procter and Gamble

More Information

No publications provided

Responsible Party:	Procter & Gamble ( Tom Todaro, MD )
Study ID Numbers:	2007021
Study First Received:	July 20, 2007
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00505778 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Gastrointestinal Diseases
Mesalamine
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases

Digestive System Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Gastrointestinal Diseases
Mesalamine
Ulcer
Physiological Effects of Drugs
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Pharmacologic Actions
Digestive System Diseases

Pathologic Processes
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Gastroenteritis
Central Nervous System Agents
Colitis

ClinicalTrials.gov processed this record on September 11, 2009