Health Condition 1: K601- Chronic anal fissure
Conditions
Interventions
Intervention1: Diltiazem Hydrochloride 2 percentage weight by weight Gel: The drug application is for twice a day (morning and evening) for 8 weeks. 1. Apply a small amount to your finger (approximate
Sponsors
Morningside Healthcare
Cliantha Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria Participant will be eligible for inclusion in this study only if all the following criteria apply: 1. Male or non-pregnant, non-lactating female participant Greater than or Equal to 18 years of Age at the screening. 2. Diagnosis of idiopathic chronic anal fissure unresponsive to previous therapy. e.g., stool softeners, a high fibre diet, and a warm sitz bath. Chronic anal fissure is defined as anal fissure persisting longer than 6 weeks prior to screening and showing the presence of at least one of the following a. Sentinel skin tag b. Hypertrophied anal papillae c. Exposed internal anal sphincter d. Fibrotic fissure margins or e. Fibrotic anal sphincter 3. Acceptable haematology status a. Haemoglobin Greater Than or Equal to 9 g per dL. b. Absolute neutrophil count-ANC Greater Than or Equal to 1500 cells per microL. c. Platelet count Greater Than or Equal to 100,000 cells per microL. d. Total white blood cell count Greater than 4000 per mm3 4. Participant with body mass index-BMI 18.5 to 30.0 kg per m2 both inclusive. 5. Non-smoker and non-tobacco user i.e., having no past history of smoking and tobacco consuming for at least one year prior to study. 6. Female participant with postmenopausal status or Female participant of child-bearing potential with a negative pregnancy test and must agree to practice an acceptable method of contraception throughout the study period. 7. Participant able to comply with the protocol requirements. 8. Participant or LAR willing to provide informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Participant will not be eligible for inclusion in this study if any of the following criteria apply: 1. Participant with history of hypersensitivity or intolerance to any of the investigational products, or to their active substances or excipients, or to similar drugs. 2. Participant presenting with any of the clinical conditions mentioned below: a. Anal fissure lacking features for chronicity. b. Cured anal fissure. c. Infected chronic anal fissure. d. Multiple fissures. e. Fissure with irregular margins. f. Fissure at locations other than the midline. g. Fissure unassociated to sphincter spasm 3. Participant with faecal incontinence, rectocele, rectal prolapse or fibrotic anal stenosis. 4. Participant with acute diarrhea at screening 5. Participant who has had lateral sphincterotomy or anal stretch or other previous surgery involving the anal canal or peri-anal region. 6. Participant treated with botulinum toxin less than 6 months prior to first dose application. 7. Participant with chronic anal fissure secondary to other disorders such as chronic inflammatory bowel disease, intestinal tuberculosis, anal or peri-anal cancer, anal fistula, sexually transmitted diseases e.g. HIV, etc., anal or peri-anal sepsis. 8. Participant with history or presence of malignant disease prior to screening. 9. Participant with clinically significant cardiovascular disorder including those diagnosed by the screening ECG, namely New York Heart Association-NYHA class III and IV heart failure, atrial fibrillation, atrioventricular block, or clinically significant bradycardia or prolonged P-R interval [Greater than 0.2 seconds or Greater than 200 milliseconds]. 10. Participant with orthostatic [postural] hypotension [i.e., a drop in systolic blood pressure of 30 mmHg or more and or a drop in diastolic blood pressure of 20 mmHg or more on standing] at the time of screening. 11. attending rcgm clerancse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic AnalysisTimepoint: At week 1 and week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with complete healing at Week 4 and Week 8Timepoint: Week 4, Week 8;Proportion of participants with decrease in pain upon defaecation using VAS scale from baseline Week 1 to Week 4 and Week 8Timepoint: Week 1 to Week 4 and Week 8 | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed