| CTRI Number |
CTRI/2022/07/044499 [Registered on: 29/07/2022] Trial Registered Prospectively |
| Last Modified On: |
29/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
An Investigator initiated Single-Arm Pilot Study Diltigesic 2% w/w Organogel (Diltiazem Hydrochloride Gel) Treatment of Chronic Anal Fissure. |
|
Scientific Title of Study
|
An Investigator initiated Single-Arm Pilot Study to Assess the Efficacy and Safety of Diltigesic 2% w/w Organogel (Diltiazem Hydrochloride Gel) in the Treatment of Chronic Anal Fissure. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No.: C2A02133 Version: 01 Date: 08 Jun 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dharmesh Domadia |
| Designation |
Vice President - Global Clinical Operations |
| Affiliation |
Cliantha Research Limited |
| Address |
TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej,
Ahmedabad – 382210, Gujarat, India.
Ahmadabad
GUJARAT
382210
India |
| Phone |
91-2717-698500 |
| Fax |
|
| Email |
ddomadia@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaydip B Gohil |
| Designation |
Assistant Manager Medical Services |
| Affiliation |
Cliantha Research Limited |
| Address |
TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej,
Ahmedabad – 382210, Gujarat, India.
Ahmadabad
GUJARAT
382210
India |
| Phone |
9601944262 |
| Fax |
|
| Email |
jbgohil@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Devesh Verma |
| Designation |
Associate Director-I |
| Affiliation |
Cliantha Research Limited |
| Address |
TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej,
Ahmedabad – 382210, Gujarat, India.
Ahmadabad
GUJARAT
382210
India |
| Phone |
9712908404 |
| Fax |
|
| Email |
dverma@cliantha.com |
|
|
Source of Monetary or Material Support
|
| Morningside Healthcare Ltd.
Morningside House
Unit C, Harcourt Way
Meridian Business Park
Leicester
LE19 1WP
UK
|
|
|
Primary Sponsor
|
| Name |
Morningside Healthcare Ltd |
| Address |
Morningside House , Unit C, Harcourt Way,
Meridian Business Park, Leicester-LE191WP, UK.
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Santosh Thorat |
Aegis Multispecialiy Hospital |
Room number 02- Clinical Research Room, Aegis Multispeciality Hospital, 1st floor, Tapaswi Plaza, Near Naivedyam Hotel, Kalbhor, Pimpri- Chinchwad, Maharashtra, 411019, India.
Pune
MAHARASHTRA |
8983377103
dr.santoshcr@gmail.com |
| Dr Rajeevkumar Bansal |
HCC Happiness Care and Cure Multispecialty Hospital LLP |
Room number 407, Clinical Trial Department, 4th floor
HCC Happiness Care and Cure Multispecialty Hospital LLP, 302, 303, 305 & 407 Shital Varsha Mall 5, Shivranjani Cross Road 380015.
Ahmadabad
GUJARAT |
9099902925
rajeevbansal.cr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sai Sneh Hospital & Diagnostic Center, Pune, Maharastra. |
Submittted/Under Review |
| Parth Institutional Ethics Committee, Naroda, Ahmedabad. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K601||Chronic anal fissure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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).
Route of administration: Topical
Duration of therapy: 04 weeks
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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 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).
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety:
Proportion of subjects for which healing rate is observed during the 4 weeks treatment period.
|
04 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
|
04 Weeks |
|
|
Target Sample Size
|
Total Sample Size="6"
Sample Size from India="6"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
|
This is an Investigator initiated single arm study.
Subjects will have to visit the clinic for the following visits during the
study:
Visit 1 Screening visit (within 2
weeks prior to baseline visit)
Visit 2 Baseline visit (Day 0)
Visit 3 Interim visit at 2 weeks
(±02 days)
Visit 4 End of Study at 4 weeks
(± 04 days)/ Early termination visit
Subjects will participate in the
study related screening activities, after obtaining the informed consent.
Screening will be performed within 2 weeks prior to baseline visit during
which eligibility will be determined.
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