chronic anal fissure MedDRA version: 20.0 Level: LLT Classification code 10071195 Term: Chronic anal fissure System Organ Class: 100000004856
Conditions
Interventions
Product Code: DRGT119
Pharmaceutical Form: Gel
INN or Proposed INN: AMLODIPINE
CAS Number: 88150-42-9
Concentration unit: % (V/V) percent volume/volume
Concentration type: equal
Concentration number:
Sponsors
Druggability Technologies Holdings Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part 1 / 1. rész: 1. Informed consent must be obtained before any assessment is performed 2. Male or non-pregnant, non-lactating female patients at least 18 years of age 3. Existing single, anal fissure for a minimum of 6 weeks as defined by the presence of a fibrous induration, exposed internal sphincter fibres, sentinel skin tag, or hypertrophic papilla 4. Resting anal pressure is equal or higher than 80 mm Hg 5. Average anal pain during/after defecation over the past two weeks is moderate to severe (VAS score: 50-100 mm) 6. Presence of a midline anal fissure, dorsal or ventral 7. Pain during and after defecation lasting for more than 6 weeks 8. Increased anal pressure due to internal anal sphincter spasm 9. Females of child bearing potential who agree to use at least one form of contraception during the full duration of the study 10. Able to communicate adequately with the investigator and to comply with the requirements for the entire study 11. Capable of and freely willing to provide written informed consent prior to participating in the study Part 2 / 2. rész: 1. Completion of all study visits and study treatment in Part 1 2. Epithelization Grade recorded as none (0) or partial (1) by the Investigator at final V6 (Day 42) visit in Part 1. 3. Willingness to participate in an additional treatment period with 0.2% DRGT-119 gel. 4. Females of child bearing potential who agree to use at least one form of contraception during the full duration of the study 5. Able to communicate adequately with the investigator and to comply with the requirements for the entire study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Part 1 1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation 2. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and minimum 16 weeks or longer if local label requires it after the last dose. 3. Ongoing use of prohibited treatments/medications (see Section 5.6.9), including: • Any agent (prescription) that is intended to treat chronic anal fissure or act directly on the anal sphincter (including, but not limited to, topical glyceryl trinitrate (GTN, also known nitroglycerin), CCBs such as nifedipine or diltiazem, and botulinum toxin), • Potassium channel or calcium channel blockers by any route of administration, • Treatment with nonsteroidal anti-inflammatory drugs (NDAIDs) other than 500 mg acetylsalicylic provided for this study.. • Laxatives 4. More than 1 anal fissure 5. Use of investigational drugs in the past 3 months prior to randomization 6. Patients who have received any agent (prescription) that is intended to treat chronic anal fissure or act directly on the anal sphincter (including, but not limited to, topical GTN, CCBs or botulinum toxin) in the past 3 months prior to randomization 7. Significant medical problems or diseases, including but not limited to the following: uncontrolled hypertension (=160/95 mmHg), congestive heart failure (New York Heart Association status of class III or IV) and uncontrolled diabetes. 8. History of clinically significant liver disease, liver injury, and/or severe hepatic insufficiency 9. Current severe progressive or uncontrolled disease which in the judgment of the clinical investigator renders the patient unsuitable for the trial 10. Any medical or psychiatric condition which, in the investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol 12. Perianal infection or abscess or fistula-in-ano 13. Previous anal surgery (with the exception of surgery that occurred = 1 year before randomization to treat haemorrhoids or chronic anal fissure, which are not exclusionary) 15. Proctitis 16. Clinically significant haemorrhoids (Grade III-IV) that in the judgement of the investigator could interfere with visualization of the fissure 18. Suspected or existing myogenic or neurogenic incontinency 19. Rectal cancer 20. Unwilling to have visual or medical examination of the anal fissure 21. Known hypersensitivity to investigational product(s) or calcium channel blockers (amlodipine, dihydropyridine derivatives or excipients) 30. Patients with history of hypotension Part 2. 1. More than 1 anal fissure 2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation 3. Any clinically significant condition, that in the judgement of the investigator, could interfere with visualization of the fissure or the patient safety in continuing treatment with DRGT-119 4. Unwilling to have visual or medical examination of the anal fissure 5. Ongoing use of prohibited treatments/medications (see Section 5.6.9)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1: To demonstrate the efficacy of local application of varying strengths of DRGT-119 gels (0.1% and 0.2%) in patients with chronic anal fissure Part 2: To demonstrate the efficacy of a second cycle of DRGT-119 0.2% gel in patients with chronic anal fissure that did not heal after completion of Part 1 of the trial ;Secondary Objective: Part 1 and Part 2: To obtain information on the safety and tolerability of varying strengths of DRGT-119 gels (0.1% [Part 1 only] and 0.2%) in patients with chronic anal fissure ;Primary end point(s): The primary endpoint of the study is based on Part 1, and is the change from baseline in resting anal pressure at Day 42. ;Timepoint(s) of evaluation of this end point: 42. day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): There are 6 secondary endpoints that will be evaluated in Part 1 of the study, in the following hierarchical order. • Incidence of complete healing of the target anal fissure • Composite of healing and pain: healing of the fissure at day 42 and a =30% decrease from baseline in the 24-hour average pain intensity at day 42 (complete responder). • Pain intensity based on a 100 mm VAS pain scale • Total Bleeding Score / Teljes vérzési pontszá • Solicited adverse events of special interest • Discontinuation of the study drug due to tolerability These endpoints will also be examined over the open-label treatment phase in Part 2 of the study. ;Timepoint(s) of evaluation of this end point: 42. and 84 days | — |
Countries
Hungary
Contacts
Public ContactStudy manager at Hungarian Office
Druggability Technologies Holdings Ltd.
Outcome results
None listed