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Asacol Acute Diverticulitis(DIVA)Study
This study is ongoing, but not recruiting participants.
First Received: November 2, 2007   Last Updated: June 17, 2009   History of Changes
Sponsor: Procter and Gamble
Information provided by: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00554099
  Purpose

The purpose of this study is to determine whether Asacol® 2.4 g/day (400 mg Mesalamine) is safe and effective in the treatment of diverticulitis.


Condition Intervention Phase
Diverticulitis
Drug: mesalamine
Other: placebo
Drug: Mesalamine and Align
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of a 12 Week Treatment of Acute Diverticulitis With Asacol® 2.4 g/Day (400 mg Mesalamine Tablet), Followed by a 9 Month Treatment-Free Observation Period

Resource links provided by NLM:


Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • Primary Outcomes: effective in decreasing the gastrointestinal symptom severity in patients after an attack of diverticulitis [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary Outcomes: assessments of surrogate markers during the treatment & non treatment period [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: November 2007
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
6 tablets(2.4 g/day) once a day of mesalamine and 1 capsule once a day of placebo plus standard care and dietary advice.
Drug: mesalamine
6 tablets(2.4 g/day) once a day of mesalamine and 1 capsule once a day of placebo plus standard care and dietary advice.
2: Active Comparator
6 tablets(2.4 g/day) once a day of mesalamine and 1 capsule once a day of Align plus standard care and dietary advice.
Drug: Mesalamine and Align
6 tablets once a day of mesalamine and 1 capsule once a day of Align plus standard care and dietary advice.
3: Placebo Comparator
6 tablets once a day of placebo and 1 capsule once a day of placebo plus standard care and dietary advice.
Other: placebo
6 tablets once a day of placebo and 1 capsule once a day of placebo plus standard care and dietary advice.

Detailed Description:

This study is designed to evaluate the safety and efficacy of Asacol® 2.4 g/day in generally healthy, adult patients who have had an attack of acute diverticulitis. The study will evaluate the safety and efficacy of a 12 week treatment with Asacol® followed a 9 month non-treatment observation period in approximately 180 patients with acute diverticulitis.

  Eligibility

Ages Eligible for Study:   49 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A clinical diagnosis of acute diverticulitis
  • Female patients must be postmenopausal (at least 1 year without spontaneous menses) or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception (e.g., abstinence; oral, intramuscular, or implanted hormonal contraception [at least 3 months prior to enrollment]; 2-barrier methods [e.g., condom, diaphragm, or spermicide]; intrauterine device or verbal report of partner with history of non-reversed vasectomy)
  • Willing and able to participate in the study and provide a signed informed consent

Exclusion Criteria:

  • Presence of diverticular complications (e.g., fistula, abscess, obstruction, stenosis);
  • Active or recent history (within 6 months) of a peptic ulcer;
  • Prior history of irritable bowel syndrome (IBS), as determined by the Investigator;
  • History of major abdominal surgery (as determined by the Investigator);
  • History of GI surgery within 3 months of diagnosis of acute diverticulitis;
  • History of immunocompromising disease, human immunodeficiency virus (HIV) infection, or acquired immunodeficiency syndrome (AIDS);
  • If female patient, active or recent history of endometriosis or dysmenorrhea;
  • Received a dose of a product that contains, or is metabolized to, mesalamine by any route within 4 weeks before the screening visit;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554099

  Show 30 Study Locations
Sponsors and Collaborators
Procter and Gamble
Investigators
Study Director: Ana Balske, MD, PhD Procter and Gamble
  More Information

No publications provided

Responsible Party: Procter and Gamble Pharmaceuticals ( Simon Magowan, MD )
Study ID Numbers: 2007020
Study First Received: November 2, 2007
Last Updated: June 17, 2009
ClinicalTrials.gov Identifier: NCT00554099     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Mesalamine
Physiological Effects of Drugs
Pharmacologic Actions
Diverticulitis
Pathologic Processes
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010