Health Condition 1: K601- Chronic anal fissure
Conditions
Interventions
Intervention1: Diltigesic 2% w/w
Organogel: Dose: Apply a small amount to your finger (approximately 2.5 cm) and place the paste just inside the anus
Frequency: Twice daily (morning and evening).
Ro
Sponsors
Morningside Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-lactating female aged 18 years old or above. 2. Diagnosis of idiopathic chronic anal fissure unresponsive to previous therapy (e.g. stool softeners, a high fiber diet, and a warm sitz bath). Chronic anal fissure defined as anal fissure persisting longer than 6 weeks prior to screening and showing the presence of at least one of the following: - sentinel skin tag - hypertrophied anal papillae - exposed internal anal sphincter - fibrotic fissure margins or - fibrotic anal sphincter 3. If female of childbearing potential, willing to use an acceptable form of birth control during the study. 4. Able to comply with the study requirements and procedures as per protocol. 5. Willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Institutionalized subject. 2. Subject 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. Subject with fecal incontinence, rectocele, rectal prolapse or fibrotic anal stenosis. 4. Subject who has had lateral sphincterotomy or anal stretch or other previous surgery involving the anal canal or peri-anal region. 5. Subject treated with botulinum toxin less than 6 months prior to enrolment. 6. Subject 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, Syphilis, etc.), anal or peri-anal sepsis. 7. Subject with history or presence of malignant disease. 8. Subject with clinically significant cardiovascular disorder, namely New York Heart Association (NYHA) class III and IV heart failure, atrial fibrillation, atrioventricular block, or clinically significant bradycardia. 9. Subject 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). 10. Unwilling to discontinue use of sitz baths for up to 4 hours after application of investigational product and unwillingness to limit sitz baths to one per day from treatment assignment to end of treatment. 11. Subject with respiratory insufficiency and need for long-term oxygen therapy or home ventilation. 12. Subject with clinically significant renal failure. 13. Subject with known neuromuscular disease. 14. Subject with any changes in the previous 12 weeks to oral, sublingual or intra-muscular therapy with vasodilators (beta-blockers, nitrates, calcium antagonists, phosphodiesterase 4 inhibitors) or muscle relaxants. 15. Use of glyceryl trinitrate (GTN) ointment for 7 days (continuous or not) in the 4 weeks prior to signing the informed consent form (ICF). f. Fissure at locations other than the midline. g. Fissure unassociated to sphincter spasm. 3. Subject with fecal incontinence, rectocele, rectal prolapse or fibrotic anal stenosis. 4. Subject who has had lateral sphincterotomy or anal stretch or other previous surgery involving the anal canal or peri-anal region. 5. Subject treated with botulinum toxin less than 6 months prior to enrolment. 6. Subject 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, Syphilis, etc.), anal or peri-anal sepsis. 7. Subject with history or presence of malignant disease. 8. Subject with clinically significant cardiovascular disorder, namely New York Heart Association (NYHA) class III and IV heart failure, atrial fibrillation, atrioventricular block, or clinically significant bradycardia. 9. Subject 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Proportion of subjects for which healing rate is observed during the 4 weeks treatment period. Timepoint: 04 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Mean change in pain score based on VAS from baseline to Week 4. Safety: Incidence of treatment-emergent adverse events, application site reaction and serious adverse events. Change in vital signs. Change in clinical laboratory parameters following study drug exposure. Timepoint: 04 Weeks | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed