drugset / Trial / NCT00767728
Mesalamine Pellet to Maintain Remission of Mild to Moderate Ulcerative Colitis
RandomizedParallel-groupDouble-blindPrevention
Summary
The purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo.
Timeline
- Start
- 2004-12
- Primary completion
- 2007-08
- Completion
- 2007-10
Publications
- Zakko SF, Gordon GL, Murthy U, Sedghi S, Pruitt R, Barrett AC, Bortey E, Paterson C, Forbes WP, Lichtenstein GR. Once-daily mesalamine granules for maintaining remission of ulcerative colitis: pooled analysis of efficacy, safety, and prognostic factors. Postgrad Med. 2016;128(3):273-81. doi: 10.1080/00325481.2016.1152876. Epub 2016 Mar 1.
- Lichtenstein GR, Gordon GL, Zakko S, Murthy U, Sedghi S, Pruitt R, Barrett AC, Bortey E, Paterson C, Forbes WP. Long-Term Benefit of Mesalamine Granules for Patients Who Achieved Corticosteroid-Induced Ulcerative Colitis Remission. Dig Dis Sci. 2016 Jan;61(1):221-9. doi: 10.1007/s10620-015-3866-7. Epub 2015 Nov 12.
- Lichtenstein GR, Zakko S, Gordon GL, Murthy U, Sedghi S, Pruitt R, Merchant K, Bortey E, Forbes WP. Mesalazine granules 1.5 g once-daily maintain remission in patients with ulcerative colitis who switch from other 5-ASA formulations: a pooled analysis from two randomised controlled trials. Aliment Pharmacol Ther. 2012 Jul;36(2):126-34. doi: 10.1111/j.1365-2036.2012.05142.x. Epub 2012 May 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Mesalamine | Small molecule | 1.5 g | Oral |