CTRI/2024/12/078489 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On:
05/01/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
A Clinical Study to Evaluate the Efficacy and Safety of Diltiazem Gel in Subjects with Chronic Anal Fissure.
Scientific Title of Study
A Randomized, Double-Blind, Multicenter, Parallel- Group, Two Arm, Placebo-Controlled Study to Assess the Efficacy and Safety of Diltiazem Hydrochloride 2 percentage Gel in the Treatment of Chronic Anal Fissure.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Protocol No.: C2A01987 Version: 04 Date: 17 May 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Vice President Global Clinical Operation
Affiliation
Cliantha Corporate
Address
TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382 210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
9879590828
Fax
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Ankesh Barnwal
Designation
Associate Director- II– Clinical Trial Medical Services
Affiliation
Cliantha Corporate
Address
TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382 210, Gujarat, India
Ahmadabad GUJARAT 382 210 India
Phone
07966219500
Fax
Email
abarnwal@cliantha.com
Details of Contact Person Public Query
Name
Mr Devesh Verma
Designation
Associate Director-I - Clinical Trials
Affiliation
Cliantha Corporate
Address
TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382 210, Gujarat, India
Ahmadabad GUJARAT 382 210 India
Phone
919712908404
Fax
Email
dverma@cliantha.com
Source of Monetary or Material Support
Morningside Healthcare
Morningside House
Unit C, Harcourt Way
Meridian Business Park, Leicester, LE19 1WP, UK
Primary Sponsor
Name
Morningside Healthcare
Address
Morningside House
Unit C, Harcourt Way
Meridian Business Park, Leicester,
LE19 1WP, UK
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Cliantha research limited
Cliantha Corporate, TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej, Ahmedabad - 382 210,
Gujarat, India
Department of Surgery, Room No.23A, Ground Floor, OPD Building, Jawahar Lal Nehru Medical College, Kala Bagh, Ajmer-305001, Rajastan Ajmer RAJASTHAN
8118877284
dr.shivbunker@outlook.com
Dr Manoj Dattatray Togale
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
OPD No. 4, Ground Floor, KLES KLES Dr. Prabhakar Kore Hospital & Medical Research Centre, Nehru Nagar, Belgavi-590010, Karnataka, India Belgaum KARNATAKA
9844706266
zapmanojtogale@gmail.com
Dr Deepak Gupta
Maharaja Agrasen Hospital
Ground Floor, Department of General Surgery, Maharaja Agrasen Hospital, West Punjabi Bagh, New Delhi-110026 New Delhi DELHI
98100158578
deepakgupta892@yahoo.com
Dr Kannan R
Mahatma Gandhi Medical College and Research Institute
Department of General Surgery , First Floor, Hospital Block, Mahatma Gandhi Medical College and Research Institute, No.45, Pondy-Cuddalore Main Road, Pillaiyarkuppam, Puducherry - 607402 Pondicherry PONDICHERRY
9442577394
kannanr@mgmcri.ac.in
Dr Chhabda Tejinder Singh
MGM Medical College & Hospital
Department of Pharmacology Clinical Trial Center, 3rd Floor, A-Wing, MGM Medical College &, Hospital, N-6, Cidco-431001, Aurangabad
Aurangabad MAHARASHTRA
9850684545
drtschhada@yahoo.com
Dr Dhaval Gupta
Mission Gastro Hospital
603, Golden Icon, Opp. Medilink Hospital, Between Shivranjani - Shyamal Cross Road, 132 Feet Ring Road, Satellite, Ahmedabad-380015
Ahmadabad GUJARAT
The drug application is for twice a day (morning and evening) for 8 weeks.
1. Apply a small amount to your finger (approximately 2.5 cm) and place the gel just inside the lower half of anus at least one hour before defecation if possible.
2. A finger covering, such as cling film or a disposable glove may be used to apply the gel.
3. Use the gel twice a day (morning and evening) for 8 weeks.
4. Wash hands after use and dispose of finger covering appropriately.
Comparator Agent
Placebo gel
The drug application is for twice a day (morning and evening) for 8 weeks.
1. Apply a small amount to your finger (approximately 2.5 cm) and place the gel just inside the lower half of anus at least one hour before defecation if possible.
2. A finger covering, such as cling film or a disposable glove may be used to apply the gel.
3. Use the gel twice a day (morning and evening) for 8 weeks.
4. Wash hands after use and dispose of finger covering appropriately.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
Subject will be eligible for inclusion in this study only if all of the following criteria apply:
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 fibre 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.
ExclusionCriteria
Details
Subject will not be eligible for inclusion in this study if any of the following criteria apply:
1. Institutionalized subjects.
2. Subject presenting with any of the clinical conditions mentioned below:
a. acute anal fissure (i.e. duration of symptoms less than 4 weeks prior to screening, and/or no induration of fissure edges).
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 faecal incontinence, rectocele, rectal prolapse or fibrotic anal stenosis.
4. Subjects unwilling to have examination of anal fissure.
5. Subject who have had lateral sphincterotomy or anal stretch or other previous surgery involving the anal canal or peri-anal region.
6. Subject treated with botulinum toxin less than 6 months prior to enrolment.
7. 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, etc.), anal or peri-anal sepsis.
8. Subject with history or presence of malignant disease.
9. Subject 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, clinically significant bradycardia or prolonged P-R interval
10. 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).
11. 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 randomization to end of treatment.
12. Subject with respiratory insufficiency and need for long-term oxygen therapy or home ventilation.
13. Subject with clinically significant renal failure (as per CKD scale Grade 3b or above).
14. Subject with known neuromuscular disease.
15. Subject with any changes in the previous 8 weeks to oral, sublingual or intra-muscular therapy with vasodilators (beta-blockers, nitrates, calcium antagonists, phosphodiesterase 4 inhibitors) or muscle relaxants.
16. Use of glyceryl trinitrate (GTN) ointment for 7 days (continuous or not) in the 4 weeks prior to signing the informed consent form (ICF).
17. Previous treatment with Diltiazem Hydrochloride cutaneous formulations or any other topical calcium channel blockers in the 8 weeks before randomization.
18. Subject who used an analgesic, anaesthetic, cicatrizant, other topical vasodilators, corticosteroid, vitamin A or E, or any other active substances that might be active in anal mucosa regeneration, less than 3 days before screening.
19. History of hypersensitivity or intolerance to any of the investigational medicinal products, or to their active substances or excipients, or to similar drugs.
20. Subject with clotting disorders.
21. Subject who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrolment.
22. Any other clinically significant abnormal findings or condition (other than anal fissure), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Other
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Proportion of subjects for which CAF healing is observed during the 8-week treatment period.
1. Proportion of subjects for which CAF healing is observed until the 6th week of treatment.
2. Proportion of subjects for which CAF healing is observed until the 4th week of treatment.
3. Mean change in pain score based on VAS from baseline to Week 4, Week 6, & Week 8.
4. Change in short form 36 health survey (SF-36) score from baseline to Week 8
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
A
study is A Multicenter, Randomized, Double-Blind, Two-Arm, Placebo-Controlled,
Parallel Design study. This clinical trial intended
to Evaluate
the Efficacy and Safety of Diltiazem hydrochloride 2% gel of Morningside
Healthcare, UK with Placebo gel of Morningside Healthcare, UK in Subjects with Chronic
Anal Fissure.