Mesalamine for Uncomplicated Diverticular Disease: a Randomized, Double-blind, Placebo-controlled Study

Dr. Falk Pharma

Status and phase: Completed; Phase 2

Conditions: Colonic Diverticulosis

Treatments: Drug: Mesalamine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01627262

SAG-20/DIV

Details and patient eligibility

About

The purpose of this study is to determine whether mesalamine is effective in the treatment of uncomplicated diverticular disease by reducing the pain.

Enrollment: 123 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of diverticular disease with acute pain without serious complications
• Lower abdominal pain of moderate or severe intensity at least during the last 4 days before study inclusion

Exclusion criteria

• Chronic inflammatory bowel disease
• Fever or other signs of serious complications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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123 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Mesalamine

Experimental group

Treatment:

Drug: Mesalamine