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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
Sponsor:
Information provided by (Responsible Party):
S.L.A. Pharma AG

Tracking Information
First Submitted Date  ICMJE July 30, 2007
First Posted Date  ICMJE July 31, 2007
Last Update Posted Date December 13, 2012
Study Start Date  ICMJE May 2005
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2011)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 30, 2007)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2011)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2007)
  • To evaluate and compare the relief of perianal pain and discomfort associated with Crohn's disease, against placebo.
  • To evaluate and compare Patient Global Impression of Improvement
  • To compare visual improvement (using photographic documentation assessed by a blinded independent observer)
  • To compare Quality of Life assessments
  • To evaluate and compare the number of analgesics required prior to treatment and to that required by the treatment and placebo group
  • To evaluate and compare fistula healing
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Topical 10% Metronidazole Ointment for the Treatment of Active Perianal Crohn's Disease
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Metronidazole 10% ointment
    Metronidazole 10% ointment
    Intervention: Drug: 10% Metronidazole Ointment
  • Placebo Comparator: Placebo ointment
    Placebo ointment
    Intervention: Drug: 10% Metronidazole Ointment
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2012)
74
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2007)
60
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00509639
Other Study ID Numbers  ICMJE MET/01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party S.L.A. Pharma AG
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE S.L.A. Pharma AG
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emin Carapeti, BSc,MBBS,MD, St Thomas Hospital, London
PRS Account S.L.A. Pharma AG
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP