A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis
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ClinicalTrials.gov Identifier: NCT00808977 |
Recruitment Status :
Completed
First Posted : December 16, 2008
Last Update Posted : November 17, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ulcerative Colitis | Drug: Dersalazine sodium Drug: Mesalazine Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Double-blind, Randomised, Placebo and Mesalazine Controlled Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Active Colitis |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Dersalazine |
Drug: Dersalazine sodium
Dersalazine sodium 2400 mg daily |
Active Comparator: Mesalazine |
Drug: Mesalazine
Mesalazine 2400 mg daily |
Placebo Comparator: Placebo |
Drug: Placebo
Placebo matching active and experimental treatments |
- Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal [ Time Frame: 7, 14, 21, 28, 56 days ]
- Mayo index [ Time Frame: 28 days ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 to 65 inclusive
- Male, non-child-bearing female or fertile female with appropriate contraception.
- Mild to moderate confirmed active ulcerative colitis
- Able and willing to give informed consent
Exclusion Criteria:
- Colitis of other cause
- Pregnancy, inadequate contraception for fertile female patients
- Liver or kidney disease, unstable cardiovascular disease, coagulation disorder.
- Other significant medical condition that preclude participation at investigator criteria
- Allergy or hypersensitivity to salicylates
- Previous or concomitant treatment for ulcerative colitis interfering with safety or activity assessments

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808977

Principal Investigator: | Julian Panés, MD | Hospital Clinic of Barcelona |
Responsible Party: | Caridad Pontes / Head Clinical Research, Palau Pharma S.A. |
ClinicalTrials.gov Identifier: | NCT00808977 |
Other Study ID Numbers: |
CR-IBD-1-08 EudraCT 2008-004610-27 ( Registry Identifier: Eudra CT ) |
First Posted: | December 16, 2008 Key Record Dates |
Last Update Posted: | November 17, 2010 |
Last Verified: | November 2010 |
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |
Mesalamine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents |