NCT02537210

Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis

Oral 5-aminosalicylic Acid Withdrawal in Long Standing Inactive Ulcerative Colitis: A Double-blind, Randomized, Placebo-controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.

Detailed description

This is a randomized, double-blind, controlled trial in which patients with long-standing clinically inactive UC receiving ASA for maintenance of remission will be randomized to either continue 5-ASA or to receive an equivalent placebo for 12 months. The primary endpoint is clinical relapse at 12 months.

Conditions

• Colitis, Ulcerative
• Aminosalicylic Acid

Interventions

Type	Name	Description
DRUG	Mesalazine	Patients will be prescribed Asacol 2g daily for 12 months
DRUG	Placebo oral capsule	Patients will be prescribed placebo 5 capsules daily for 12 months

Timeline

• Start date: 2015-09-01
• Primary completion: 2021-09-10
• Completion: 2021-09-10
• First posted: 2015-09-01
• Last updated: 2023-05-31

Locations

1 site across 1 country: Hong Kong