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New treatment option for Anal Fissure
Official title Comparative Evaluation of MEBO Ointment and Topical Diltiazem Ointment in the Treatment of Acute Anal Fissure
ClinicalTrials.gov ID: NCT04153032
What this study is testing
What is Diltiazem?
Diltiazem is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for anal fissure.
Also referred to as DTZ.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- No study to date has compared topical DTZ to MEBO ointment in the treatment of anal fissure. Therefore, the present study aims to compare the efficacy and safety of DTZ to MEBO in the treatment of acute anal fissure.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must be 18 years and above.
- people with 3 months (90 days) or less history of painful anal fissure (AF), prior to screening, where AF-related pain-associated with, or following...
- people with an average of ≥4 on an 11-point NRS during the screening phase for worst anal pain associated with, or following, defecation for the most...
- people with evidence of a radial fissure, with induration at the edges, seen on anal examination.
- Willing to stop all other concomitant topical preparations applied perianally prior to commencing study treatment, and throughout the study. There...
You likely can't join if
- people unwilling to be examined for AF.
- people who have undergone the following procedures:
- Lateral sphincterotomy or anal stretch or other previous surgery involving the anal canal or perianal region (hemorrhoidectomy, anal fistula surgery).
- Incision of perianal abcess.
- people who have had sub-fissure injection of botulinum toxin within 6 months period prior to screening, or have used glyceryl trinitrate (GTN)...
- people with AF associated with other conditions (drug-induced [e.g. nicorandil], trauma, HIV infection, fistula-in-ano, inflammatory bowel disease...
See the full eligibility criteria
- people must be 18 years and above.
- people with 3 months (90 days) or less history of painful anal fissure (AF), prior to screening, where AF-related pain-associated with, or following, defecation is experienced at least twice a week during the...
- people with an average of ≥4 on an 11-point NRS during the screening phase for worst anal pain associated with, or following, defecation for the most recent 3 days on which the subject has defecated.
- people with evidence of a radial fissure, with induration at the edges, seen on anal examination.
- Willing to stop all other concomitant topical preparations applied perianally prior to commencing study treatment, and throughout the study. There will be a "washout" period of at least 2 weeks prior to commencing the...
- Able to give consent
- people unwilling to be examined for AF.
- people who have undergone the following procedures:
- Lateral sphincterotomy or anal stretch or other previous surgery involving the anal canal or perianal region (hemorrhoidectomy, anal fistula surgery).
- Incision of perianal abcess.
- people who have had sub-fissure injection of botulinum toxin within 6 months period prior to screening, or have used glyceryl trinitrate (GTN) ointment for \>1 week in the 4 weeks prior to the screening visit.
- people with AF associated with other conditions (drug-induced [e.g. nicorandil], trauma, HIV infection, fistula-in-ano, inflammatory bowel disease, perianal sepsis or malignancy).
- people with cardiovascular disease
- people with known hypersensitivity to DTZ or the ingredients of MEBO (Sesame oil)
- people taking medications prohibited by the protocol.
- people who have taken experimental agents must have been discontinued at least 8 weeks prior to screening, or for a period equivalent to 5 half-lives (t1/2) of the agents.
- people who have the following gastrointestinal disorders:
- Inflammatory bowel disease.
- Chronic faecal incontinence.
- History of radiation therapy to the pelvis.
- Fixed anal stenosis/fibrosis.
- people with major psychiatric (including drug or alcohol abusers), or haematological illness. (diseases of the vascular system; source: )people with planned elective or other treatment requiring hospitalization, during...
- people who will be unavailable for the duration of the trial, likely to be noncompliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason.
- Patients who are taking oral therapy for anal fissure will also be excluded from the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beirut, Lebanon
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beirut, Lebanon. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.