The Efficacy of Asacol (Mesalazine) Suppository on the Treatment of Diarrhea-Induced Acute Fissure

NCT05091775 | Completed Phase 1 DMC

• 1 other identifier: 98-01-01-21181
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Anal fissure define as a superficial tearing in mucosa on the anoderm surface distal to dentate line . The most important factor is hard stool passing with trauma to anal mucosa. But, diarrhea diarrhea has been another important etiology that happen after some conditions like gastroenteritis, laxative over use, during chemotherapy, and ulcerative colitis exacerbation . In these conditions, it seems the change of stool PH maybe the main reason of inflammation and ulcer in acute phase. The treatment of acute is medical management with change in bowel habits and conservative therapy such as local lubricant, local vasodilator, and warm sitz bath to improve blood supply and wound healing. This research clinical trial is designed to show the effect of Asacol suppository in the management of acute fissure due to diarrhea. The hypothesis of this research clinical trial has been referred to the cause of acute fissure ulcer because of diarrhea.

Conditions

Fissure in Ano; Diarrhea

Keywords

Acute fissure; Diarrhea; Asacol

Outcome Measures

Primary Outcomes (1)

• Acute anal fissure after diarrhea. Standard management of acute fissure (Diltiazem Jelly, supportive care, placebo suppository, sitz bath)

  bleeding anal fissure. After 2weeks the patients will visit. The score of pain, burning sensation, bleeding and improvement will be recorded in two groups. Score of pain with visual analog scale (VAS) is a tool widely used to measure pain; Scale (0-10) that higher grade means higher pain. Burning sensation (yes, no) and bleeding (yes, no) and improvement (yes, no) will be recorded

  2 weeks

Secondary Outcomes (1)

• Acute anal fissure after diarrhea. Intervention group (Asacol suppository, supportive care, placebo suppository, sitz bath)

  3 months

Study Arms (2)

Standard management of acute fissure(Diltiazem Jelly,supportive care,placebo suppository, sitz bath)

PLACEBO COMPARATOR

Patients in the first group underwent for 14 consecutive days treatment with diltiazem gel 2 times a day, a basin of warm water 2 times a day and drink daily 8-12 a glass of water will be placed with a placebo suppository.

Drug: Asacol is used to treat and prevent mild to moderate acute fissure disease

Intervention group (Asacol suppository, supportive care, placebo suppository, sitz bath)

EXPERIMENTAL

Patients in the second group or treatment group will be treated with diltiazem gel topically 3 times a day for 14 consecutive days, pelvis of warm water 2 times a day and drink daily 8-12 glasses of water plus Asacol anal suppository (mesalazine) are taken 1 piece every night.

Drug: Asacol is used to treat and prevent mild to moderate acute fissure disease

Interventions

Asacol is used to treat and prevent mild to moderate acute fissure disease DRUG

Comparison of two groups after 2 weeks in fissure wound healing, pain relief, pruritus, burning, bleeding, incontinence. Preliminary results of the study show the rate of fissure improvement 6 weeks after treatment, which is observed by clinical examination. Restoration is defined by complete epithelialization of the fissure site without scarring or residual cracks, and the secondary results will be a reduction in the amount of pain and other symptoms.

Also known as: Mesalazine is used to treat and prevent mild to moderate acute fissure disease

Intervention group (Asacol suppository, supportive care, placebo suppository, sitz bath); Standard management of acute fissure(Diltiazem Jelly,supportive care,placebo suppository, sitz bath)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For age between 18 and 65 years are the presence of acute anal fissure (with symptoms less than 6 weeks) following chronic diarrhea and subsequent fissure.

You may not qualify if:

• Recurrent fissure with skin appendage.
• Long history of constipation.
• Use of immunosuppressive drugs or corticosteroids.
• Inflammatory bowel disease such as Crohn's disease and ulcerative colitis.
• Pregnancy.
• Grade 3 and 4 hemorrhoids.
• Neurological disease.
• Obsessive-compulsive disorder.
• Previous history of anal surgery
• Skin diseases such as eczema and psoriasis.
• Sexually transmitted infections, tuberculosis.
• Mucosal prolapse.
• Anal fistula and pelvic radiotherapy.

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Leila Ghahramani

Shiraz, Fars, 7193635899, Iran

Location

MeSH Terms

Conditions

Fissure in Ano; Diarrhea

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associated professor of colorectal surgery

Model Details: two groups seventy patients aged 18 to 65 years with diarrhea and subsequent acute fissure (with symptoms less than 6 weeks)

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: October 25, 2021
• Study Start: June 1, 2020
• Primary Completion: August 2, 2020
• Study Completion: January 10, 2021
• Last Updated: October 25, 2021

Record last verified: 2021-10

Locations

IR (1)