Fissure in AnoPhase 1/2NCT05091775
The Efficacy of Asacol (Mesalazine) Suppository on the Treatment of Diarrhea-Induced Acute Fissure
A Phase 1/2 study testing Asacol is used to treat and prevent mild to moderate acute fissure disease in people with Fissure in Ano and Diarrhea, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fissure in Ano, Diarrhea
- What is being tested?
- Asacol is used to treat and prevent mild to moderate acute fissure disease
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteIran
- Study dates
- 1 Jun 2020to 10 Jan 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of the Efficacy of Asacol (Mesalazine) Suppository on the Treatment of Diarrhea-Induced Acute Fissure in Post-Chemotherapy Cancer Patients - A Randomized Controlled Trial
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.
Read the detailed description
The cases with acute anal fissure after diarrhea will included in this research clinical trial. They will be divided in two groups as an interventional group and control by blind randomization allocation. The interventional group will have received Asacol suppository 1 supp every night and Diltiazem jelly (standard management) twice per day. The control group will have received Diltiazem jelly and placebo suppository like interventional group. Both group will have used warm sitz bath with enough hydration for 10 days. Then the patients will have visited by another surgeon after 4 weeks to evaluate the healing of acute anal fissure. Pain will have performed if the patients can tolerate.
- Conditions
- Fissure in Ano, Diarrhea
- Being tested
- Asacol is used to treat and prevent mild to moderate acute fissure disease
- Keywords
- Acute fissure, Diarrhea, Asacol
- Medical subject headings
- Fissure in Ano, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asacol is used to treat and prevent mild to moderate acute fissure diseaseDrug
Also called Mesalazine is used to treat and prevent mild to moderate acute fissure disease
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Asacol is used to treat and prevent mild to moderate acute fissure disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (1)
Acute anal fissure after diarrhea. Intervention group (Asacol suppository, supportive care, placebo suppository, sitz bath)
need surgery or botox injection. Both group including 70 patients that will visit after 2 weeks for evaluating heading acute fissure by history and physical examination.
Bleeding(decrease/increase) Pruritus(decrease/increase) Wound healing (according to surgeon evaluation)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 Jun 2020
- Primary completion2 Aug 2020
- Study completion10 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fissure in AnoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups seventy patients aged 18 to 65 years with diarrhea and subsequent acute fissure (with symptoms less than 6 weeks)
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Ghahramani, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091775
- Sponsor's protocol ID
- 98-01-01-21181
- Status last verified
- Oct 2021
- First submitted
- 27 Apr 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Efficacy of Asacol (Mesalazine) Suppository on the Treatment of Diarrhea-Induced Acute Fissure in Post-Chemotherapy Cancer Patients - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05091775
- Acronym / sponsor ID
- 98-01-01-21181
- Conditions
- Fissure in Ano, Diarrhea
- Keywords
- Acute fissure, Diarrhea, Asacol
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 2 Aug 2020 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The cases with acute anal fissure after diarrhea will included in this research clinical trial. They will be divided in two groups as an interventional group and control by blind randomization allocation. The interventional group will have received Asacol suppository 1 supp every night and Diltiazem jelly (standard management) twice per day. The control group will have received Diltiazem jelly and placebo suppository like interventional group. Both group will have used warm sitz bath with enough hydration for 10 days. Then the patients will have visited by another surgeon after 4 weeks to evaluate the healing of acute anal fissure. Pain will have performed if the patients can tolerate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- two groups seventy patients aged 18 to 65 years with diarrhea and subsequent acute fissure (with symptoms less than 6 weeks)
| Arm | Type | Receives |
|---|---|---|
| Standard management of acute fissure(Diltiazem Jelly,supportive care,placebo suppository, sitz bath) | Placebo comparator | Drug: Asacol is used to treat and prevent mild to moderate acute fissure diseasePatients 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. |
| Intervention group (Asacol suppository, supportive care, placebo suppository, sitz bath) | Experimental | Drug: Asacol is used to treat and prevent mild to moderate acute fissure diseasePatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asacol is used to treat and prevent mild to moderate acute fissure diseaseAlso: Mesalazine is used to treat and prevent mild to moderate acute fissure diseaseComparison 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. | Drug | Intervention group (Asacol suppository, supportive care, placebo suppository, sitz bath), Standard management of acute fissure(Diltiazem Jelly,supportive care,placebo suppository, sitz bath) |
Primary outcome
Acute anal fissure after diarrhea. Standard management of acute fissure (Diltiazem Jelly, supportive care, placebo suppository, sitz bath)
Time frame: 2 weeks
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
1 secondary outcome
Acute anal fissure after diarrhea. Intervention group (Asacol suppository, supportive care, placebo suppository, sitz bath)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Asacol is used to treat and prevent mild to moderate acute fissure disease in people with Fissure in Ano and Diarrhea, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute anal fissure after diarrhea. Standard management of acute fissure (Diltiazem Jelly, supportive care, placebo suppository, sitz bath) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.