NCT00509639

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2005

Typical duration for phase_3

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

December 13, 2012

Status Verified

December 1, 2012

Enrollment Period

2.8 years

First QC Date

July 30, 2007

Last Update Submit

December 12, 2012

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    Perianal Crohn's Disease Activity Index

    Four weeks

Secondary Outcomes (6)

  • To evaluate and compare the relief of perianal pain and discomfort associated with Crohn's disease, against placebo.

    4 weeks

  • To evaluate and compare Patient Global Impression of Improvement

    4 weeks

  • To compare visual improvement (using photographic documentation assessed by a blinded independent observer)

    4 weeks

  • To compare Quality of Life assessments

    4 weeks

  • To evaluate and compare the number of analgesics required prior to treatment and to that required by the treatment and placebo group

    4 weeks

  • +1 more secondary outcomes

Study Arms (2)

Metronidazole 10% ointment

EXPERIMENTAL

Metronidazole 10% ointment

Drug: 10% Metronidazole Ointment

Placebo ointment

PLACEBO COMPARATOR

Placebo ointment

Drug: 10% Metronidazole Ointment

Interventions

10% Metronidazole OintmentDRUG

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

Metronidazole 10% ointmentPlacebo ointment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Washington University School of Medicine

St Louis, Missouri, M 63110, United States

Location

Derby City General Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

Leicester General Hospital

Leicester, Leicestershire, LE5 4PW, United Kingdom

Location

Monklands Hospital

Airdrie, ML6 0JS, United Kingdom

Location

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

Bristol Royal Infirmary

Bristol, BS1 3NU, United Kingdom

Location

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Location

University Hospital of Warwick and Coventry

Coventry, CV2 2DX, United Kingdom

Location

St Marks Hospital

Harrow, HA1 3UJ, United Kingdom

Location

St Thomas Hospital

London, SE1 &EH, United Kingdom

Location

Peterborough District Hospital

Peterborough, PE3 6DA, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 20632322DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Emin Carapeti, BSc,MBBS,MD,

    St Thomas Hospital, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2007

First Posted

July 31, 2007

Study Start

May 1, 2005

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

December 13, 2012

Record last verified: 2012-12

Locations

GB(10)US(1)