Trial of Mesalamine for the Treatment of Active Microscopic Colitis
NCT00952952 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2011-05-24
Summary
Subjects must be 18 years old and older, have diarrhea and microscopic colitis. Pregnant or nursing females are excluded. They can't have other untreated diarrheal conditions. Subjects will receive medication for 8 weeks, followed by sigmoidoscopy with biopsies. The subjects will be monitored weekly. A pathologist will review pre and post treatment biopsies. Subjects that show improvement will be followed for 4 weeks post medication.
Conditions
- Microscopic Colitis
- Diarrhea
Interventions
- DRUG
-
Mesalamine
Sponsors & Collaborators
-
Paul E. Evans MD
collaborator UNKNOWN -
William J. Sandborn MD
collaborator UNKNOWN -
Edward V. Loftus MD
collaborator UNKNOWN -
Thomas C. Smryk MD
collaborator UNKNOWN -
Willaim Tremaine MD
collaborator UNKNOWN - lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-02-28
- Primary Completion
- 2007-11-30
- Completion
- 2007-11-30
Countries
- United States
Study Locations
More Related Trials
-
Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis
NCT01586533 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis
NCT01011322 ·Status: UNKNOWN ·Phase: PHASE2
-
A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis
NCT01045018 ·Status: COMPLETED ·Phase: PHASE3
-
TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)
NCT01745770 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)
NCT02849951 ·Status: TERMINATED ·Phase: PHASE3
-
Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
NCT02435992 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis
NCT01130844 ·Status: COMPLETED ·Phase: PHASE1
-
Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis
NCT00408174 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
NCT00073021 ·Status: COMPLETED ·Phase: PHASE3
-
Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)
NCT02522767 ·Status: COMPLETED ·Phase: PHASE3
-
Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)
NCT02522780 ·Status: COMPLETED ·Phase: PHASE3
-
Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis
NCT01257386 ·Status: COMPLETED ·Phase: PHASE3
-
Mesalamine Pellet Formulation to Maintain Remission of Mild to Moderate Ulcerative Colitis
NCT00744016 ·Status: COMPLETED ·Phase: PHASE3
-
Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC)
NCT00446849 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Compliance of Taking Mesalamine Once a Day in Pediatric Patients
NCT00349388 ·Status: TERMINATED ·Phase: NA
-
TP0501 - Pharmaco-Scintigraphic-Study
NCT02306772 ·Status: COMPLETED ·Phase: PHASE1
-
Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis
NCT01020708 ·Status: COMPLETED ·Phase: PHASE1
-
Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative Colitis
NCT03110198 ·Status: UNKNOWN ·Phase: PHASE4
-
Asacol Dosing Study for Active Ulcerative Colitis
NCT00194818 ·Status: COMPLETED ·Phase: PHASE4
-
A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's Disease
NCT00207662 ·Status: COMPLETED ·Phase: PHASE3
-
Predicting Response to Standardized Pediatric Colitis Therapy
NCT01536535 ·Status: COMPLETED ·Phase: PHASE4
-
A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis
NCT01805791 ·Status: TERMINATED ·Phase: PHASE3
-
An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease
NCT03599622 ·Status: TERMINATED ·Phase: PHASE2
-
Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase
NCT01257399 ·Status: COMPLETED ·Phase: PHASE3
-
TP0502-Pharmaco-Scintigraphic-Study and Amendment
NCT02306785 ·Status: COMPLETED ·Phase: PHASE1