A Double Blind Study for the Treatment of Acute Ulcerative Colitis - Full Text View

Sponsored by:	Procter and Gamble
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00350415

Purpose

A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND III).

Condition	Intervention	Phase
Ulcerative Colitis	Drug: Mesalamine	Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Mesalamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, 6-Week, Parallel-Group Design Clinical Trial to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day for the Treatment of Moderately Active Ulcerative Colitis.

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

Proportion of patients (ITT) in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6. [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients (ITT) in pre-defined subgroups in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6 and Week 3. [ Time Frame: week 3 and 6 ] [ Designated as safety issue: No ]

Enrollment:	772
Study Start Date:	June 2006
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Asacol 2.4 g/day (400 mg tablet)	Drug: Mesalamine Asacol 400g/day (400 mg tablet), oral, for 6 weeks OR Asacol 4,8 g/day (800 mg table), oral, for 6 weeks
2: Active Comparator Asacol 4,8 g/day (800 mg tablet), oral, for 6 weeks	Drug: Mesalamine Asacol 400g/day (400 mg tablet), oral, for 6 weeks OR Asacol 4,8 g/day (800 mg table), oral, for 6 weeks

Detailed Description:

This is a double-blind, randomized, multi-center, multi-national, active-control study in patients who are experiencing a moderately active flare of UC. Patients will be randomly assigned to receive either Asacol 2.4 g/day (400 mg tablet) or Asacol 4.8 g/day (800 mg tablet) for 6 weeks. Patients will be randomized to one of the 2 treatment groups in a 1:1 ratio. The objective of the study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) compared to Asacol 2.4 g/day (400 mg tablet) in this patient population. Following successful screening, patients will be randomized to one of the two treatment arms. Patients will be evaluated after 6 weeks of treatment with an interim visit after 3 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients 18-75 years with a confirmed diagnosis of moderately active flare of ulcerative colitis.
Female patients need to be postmenopausal or using adequate contraception.

Exclusion Criteria:

Patients with isolated proctitis
Patients with comorbidities or an investigative or commercialized treatments confounding interpretation of study results or compromising patients' safety in the trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350415

Show 135 Study Locations

Sponsors and Collaborators

Procter and Gamble

Investigators

Study Director:

Piotr Krzeski, MD

Procter and Gamble

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Procter and Gamble Pharmaceuticals ( Piotr Krzeski, MD, MD )
Study ID Numbers:	2006444
Study First Received:	July 6, 2006
Last Updated:	February 5, 2008
ClinicalTrials.gov Identifier:	NCT00350415
Health Authority:	United States: Food and Drug Administration

Keywords provided by Procter and Gamble:

ulcerative colitis, inflammatory bowel disease

Study placed in the following topic categories:

Digestive System Diseases
Mesalamine
Gastrointestinal Diseases
Ulcer
Colonic Diseases

Inflammatory Bowel Diseases
Colitis, Ulcerative
Gastroenteritis
Intestinal Diseases
Colitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Pathologic Processes
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs

Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009