Study Stopped
Slow inclusion rate
Treatment Of Chronic Anal Fissure
TOCA
1 other identifier
interventional
55
1 country
2
Brief Summary
The purpose of this study is to investigate the effect of Levorag Emulgel compared with diltiazem gel on the healing of chronic anal fissures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2014
Longer than P75 for not_applicable
2 active sites
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
First Submitted
Initial submission to the registry
June 5, 2014
CompletedFirst Posted
Study publicly available on registry
June 6, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2018
CompletedJanuary 14, 2020
January 1, 2020
3.4 years
June 5, 2014
January 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Complete healing at week 12
Complete healing of the anal fissure after 12 weeks
12 weeks
Secondary Outcomes (4)
Complete healing at week 8
8 weeks
Defecation pain at day 3
3 days
Defecation pain at day 7
7 days
Adverse events
12 weeks
Other Outcomes (2)
Incontinence
8 and 12 weeks
Anal resting pressure
8 and 12 weeks
Study Arms (2)
Diltiazem, calcium channel blocker
ACTIVE COMPARATORDiltiazem gel 2% applied twice daily for 8 weeks
Levorag, Hibiscus plant extract
EXPERIMENTALLevorag Emulgel applied twice daily for 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Danish citizens, age ≥ 18 years
- Presence of a midline anal fissure, dorsal or ventral
- Pain during and after defecation lasting for more than 8 weeks
- Presence of a sentinel anal tag or hypertrophic papilla
- Exposure of the horizontal fibres of the internal anal sphincter
You may not qualify if:
- Inflammatory bowel disease, known venereal disease, immunodeficiency disease
- Anal/perianal abscess
- Anal or rectal surgery within 12 weeks
- Pregnancy or breastfeeding females
- History of migraine or chronic headache requiring treatment with analgetics
- Any cardiovascular or cerebrovascular disease
- Current use of calcium channel blockers in general or history of use of calcium channel blockers in the treatment of the fissure
- Signs of other rectal diseases, fistula, infection including severe perianal eczema and tumours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bispebjerg Hospitallead
- Sacomedcollaborator
Study Sites (2)
Department of Surgery P, Aarhus University Hospital
Aarhus, DK8000, Denmark
Digestive Disease Center, Bispebjerg Hospital
Copenhagen, DK2400, Denmark
Related Publications (1)
Nordholm-Carstensen A, Perregaard H, Wahlstrom KL, Hagen KB, Hougaard HT, Krarup PM. Treatment of chronic anal fissure: a feasibility study on Levorag(R) Emulgel versus Diltiazem gel 2. Int J Colorectal Dis. 2020 Apr;35(4):615-621. doi: 10.1007/s00384-020-03515-z. Epub 2020 Jan 24.
PMID: 31980871DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Peter-Martin Krarup, MD
Bispebjerg Hospital
- PRINCIPAL INVESTIGATOR
Andreas Nordholm-Carstensen, MD
Bispebjerg Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 5, 2014
First Posted
June 6, 2014
Study Start
September 1, 2014
Primary Completion
February 5, 2018
Study Completion
February 5, 2018
Last Updated
January 14, 2020
Record last verified: 2020-01