Evaluation of Topical 10% Metronidazole Ointment for the Treatment of Active Perianal Crohn's Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00509639 |
Recruitment Status :
Completed
First Posted : July 31, 2007
Last Update Posted : December 13, 2012
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Drug: 10% Metronidazole Ointment | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 74 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, 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 |
Study Start Date : | May 2005 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | February 2008 |

Arm | Intervention/treatment |
---|---|
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 |
- To evaluate the effect of 10% metronidazole ointment, applied topically three times a day, in and around the anus, on the change in perianal Crohn's disease activity. [ Time Frame: Four weeks ]Perianal Crohn's Disease Activity Index
- To evaluate and compare the relief of perianal pain and discomfort associated with Crohn's disease, against placebo. [ Time Frame: 4 weeks ]Perianal Crohn's Disease Activity Index plus Visual Analogue Scale for perianal pain
- To evaluate and compare Patient Global Impression of Improvement [ Time Frame: 4 weeks ]Patient Global Impression of Improvement (numerical scale)
- To compare visual improvement (using photographic documentation assessed by a blinded independent observer) [ Time Frame: 4 weeks ]Photographic record
- To compare Quality of Life assessments [ Time Frame: 4 weeks ]Short Form 12 Questionnaire
- To evaluate and compare the number of analgesics required prior to treatment and to that required by the treatment and placebo group [ Time Frame: 4 weeks ]Usage of analgesics during the treatment period
- To evaluate and compare fistula healing [ Time Frame: 4 weeks ]Visual assessment of fistula healing

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Have Crohn's disease (diagnosed by radiology, endoscopy and pathology), with anorectal involvement.
- Have had perianal symptoms for longer than 3 months
- Have a PCDAI of 5 or above at baseline
- Subjects can be on concomitant medication. Acceptable regimes are:-
- Aminosalicylates at a dosage that has been stable for more than 4 weeks before screening;
- Oral corticosteroids <40mg per day that has been stable for more than 3 weeks;
- Methotrexate given for at least 3 months that has been stable for more than 4 weeks; Azathioprine or mercaptopurine given for at least 6 months at dosage that has been stable for more than 8 weeks;
- Antibiotics at a dosage that has been stable for 4 weeks (subjects may be on oral metronidazole but on a dose not more than 750mg per day),
- Cycolsporin for more than 3 months and on a stable dose for more than 4 weeks;
- Patients who have been treated with Infliximab must have received their initial dose 3 months before starting study medication and their most recent dose at least 8 weeks before starting study medication and not receive an infusion whilst in the double-blind treatment phase of the study for 4 weeks. During the second 4 week open stage of the study patients can commence again a maintenance regime with Infliximab treatment if deemed necessary
- Any patients not on concurrent medication must have been off medication for at least 4 weeks before screening.
- If patients have Setons these must have been in place for at least 4 weeks prior to screening.
- Subjects must be aged 18 years or over and of the legal age of consent.
- If female, the subject must not be lactating and must be (a) post- menopausal, (b) surgically sterilised, or (c) have a negative pregnancy test result prior to entry into the study and will use double- barrier methods of contraception (two separate methods of birthcontrol one of which may include oral contraception) for the duration of the study.
- Must have provided written informed consent to participate.
Exclusion Criteria:
- They have had surgery to the anus or rectum in the past 4 weeks;
- They have a perianal abscess requiring incision and drainage;
- They have a stoma of less than 6 months duration;
- Allergic to metronidazole;
- Are taking any prohibited medication.
- Deemed mentally incompetent.
- Considered by their physician unlikely to be able to comply with the protocol.
- Taken part in an experimental drug study in the preceding three months.

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): NCT00509639
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 |
Responsible Party: | S.L.A. Pharma AG |
ClinicalTrials.gov Identifier: | NCT00509639 |
Other Study ID Numbers: |
MET/01 |
First Posted: | July 31, 2007 Key Record Dates |
Last Update Posted: | December 13, 2012 |
Last Verified: | December 2012 |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
Metronidazole Anti-Infective Agents Anti-Bacterial Agents Antiprotozoal Agents Antiparasitic Agents |