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| Sponsor: | S.L.A. Pharma AG |
|---|---|
| Information provided by: | S.L.A. Pharma AG |
| ClinicalTrials.gov Identifier: | NCT00509639 |
Purpose
The purpose of this study is to compare changes in Perianal Crohn's Disease following use of locally applied 10% metronidazole ointment and a placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Disease |
Drug: 10% Metronidazole Ointment |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase III Study to Evaluate the Effect of 10% Metronidazole Ointment, Applied Topically Three Times a Day in and Around the Anus and the Change in Perianal Crohn's Disease Activity |
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2005 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Metronidazole 10% ointment
Metronidazole 10% ointment
|
Drug: 10% Metronidazole Ointment
Metronidazole 10% ointment applied perianally three times daily for four weeks. Placebo ointment applied perianally three times daily for four weeks
|
|
Placebo Comparator: Placebo ointment
Placebo ointment
|
Drug: 10% Metronidazole Ointment
Metronidazole 10% ointment applied perianally three times daily for four weeks. Placebo ointment applied perianally three times daily for four weeks
|
Anorectal Crohn's disease is one of the most problematic and debilitating conditions encountered in colorectal practise. The condition is usually chronic, debilitating, and frequently refractory to current medications. Failure to respond to medical therapy may ultimately result in proctocolectomy and ileostomy, even in the absence of more proximal colonic disease. Isolated anorectal Crohn's disease is reported in 3 to 5% of Crohn's patients. In Crohn's patients as a whole, anorectal involvement is reported in up to one third to one half of patients, in addition to either colonic or enteric Crohn's disease. In spite of the previously reported painless nature of anorectal Crohn's disease, it is the author's experience that the condition can be inordinately painful due to deeply eroding fissures, oedematous skin tags, and painful induration of the perianal region.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Missouri | |
| Washington University School of Medicine | |
| St Louis, Missouri, United States, M 63110 | |
| United Kingdom | |
| Derby City General Hospital | |
| Derby, Derbyshire, United Kingdom, DE22 3NE | |
| Leicester General Hospital | |
| Leicester, Leicestershire, United Kingdom, LE5 4PW | |
| Monklands Hospital | |
| Airdrie, United Kingdom, ML6 0JS | |
| Birmingham Heartlands Hospital | |
| Birmingham, United Kingdom, B9 5SS | |
| Bristol Royal Infirmary | |
| Bristol, United Kingdom, BS1 3NU | |
| University Hospital of Wales | |
| Cardiff, United Kingdom, CF14 4XW | |
| University Hospital of Warwick and Coventry | |
| Coventry, United Kingdom, CV2 2DX | |
| St Marks Hospital | |
| Harrow, United Kingdom, HA1 3UJ | |
| St Thomas Hospital | |
| London, United Kingdom, SE1 &EH | |
| Peterborough District Hospital | |
| Peterborough, United Kingdom, PE3 6DA | |
| Principal Investigator: | Emin Carapeti, BSc,MBBS,MD, | St Thomas Hospital, London |
More Information
| Responsible Party: | Dr C C Jordan, S L A Pharma UK Ltd |
| ClinicalTrials.gov Identifier: | NCT00509639 History of Changes |
| Other Study ID Numbers: | MET/01 |
| Study First Received: | July 30, 2007 |
| Last Updated: | June 7, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Metronidazole |
Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents |