Evaluation of Topical 10% Metronidazole Ointment for the Treatment of Active Perianal Crohn's Disease

NCT ID: NCT00509639

Last Updated: 2012-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2008-02-29

Brief Summary

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.

Detailed Description

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Metronidazole 10% ointment

Metronidazole 10% ointment

Group Type: EXPERIMENTAL

10% Metronidazole Ointment

Intervention Type: DRUG

Metronidazole 10% ointment applied perianally three times daily for four weeks. Placebo ointment applied perianally three times daily for four weeks

Placebo ointment

Placebo ointment

Group Type: PLACEBO_COMPARATOR

10% Metronidazole Ointment

Intervention Type: DRUG

Metronidazole 10% ointment applied perianally three times daily for four weeks. Placebo ointment applied perianally three times daily for four weeks

Interventions

10% Metronidazole Ointment

Metronidazole 10% ointment applied perianally three times daily for four weeks. Placebo ointment applied perianally three times daily for four weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

S.L.A. Pharma AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emin Carapeti, BSc,MBBS,MD,

Role: PRINCIPAL_INVESTIGATOR

St Thomas Hospital, London

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Derby City General Hospital

Derby, Derbyshire, United Kingdom

Leicester General Hospital

Leicester, Leicestershire, United Kingdom

Monklands Hospital

Airdrie, , United Kingdom

Birmingham Heartlands Hospital

Birmingham, , United Kingdom

Bristol Royal Infirmary

Bristol, , United Kingdom

University Hospital of Wales

Cardiff, , United Kingdom

University Hospital of Warwick and Coventry

Coventry, , United Kingdom

St Marks Hospital

Harrow, , United Kingdom

St Thomas Hospital

London, , United Kingdom

Peterborough District Hospital

Peterborough, , United Kingdom

Countries

United States; United Kingdom

References

Maeda Y, Ng SC, Durdey P, Burt C, Torkington J, Rao PK, Mayberry J, Moshkovska T, Stone CD, Carapeti E, Vaizey CJ; Topical Metronidazole in Perianal Crohn's Study Group. Randomized clinical trial of metronidazole ointment versus placebo in perianal Crohn's disease. Br J Surg. 2010 Sep;97(9):1340-7. doi: 10.1002/bjs.7121.

Reference Type: DERIVED

PMID: 20632322 (View on PubMed)

Other Identifiers

MET/01

Identifier Type: -

Identifier Source: org_study_id