| CTRI Number |
CTRI/2025/04/086055 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Post Marketing Surveillance study of
the Fixed-dose combination tablets of Drotaverine 80 mg and Aceclofenac 100
mg in patients with Colicky pain due to smooth muscle spasm. |
|
Scientific Title of Study
|
A Multicenter, Open-label, Single-arm Post Marketing Surveillance study of
the Fixed-dose combination tablets of Drotaverine 80 mg and Aceclofenac 100
mg in patients with Colicky pain due to smooth muscle spasm. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avinash Andhale |
| Designation |
Principal Investigator |
| Affiliation |
Vivotech Research Private Limited |
| Address |
Plot no D17 4 TTC Industrial Area Turbhe MIDC Navi Mumbai 400703 India
Plot no D17 4 TTC Industrial Area Turbhe MIDC Navi Mumbai 400703 India
Thane
MAHARASHTRA
400703
India |
| Phone |
9987598349 |
| Fax |
|
| Email |
pi@vivotechresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avinash Andhale |
| Designation |
Principal Investigator |
| Affiliation |
Vivotech Research Private Limited |
| Address |
Plot no D17 4 TTC Industrial Area Turbhe MIDC Navi Mumbai 400703 India
Plot no D17 4 TTC Industrial Area Turbhe MIDC Navi Mumbai 400703 India
MAHARASHTRA
400703
India |
| Phone |
9987598349 |
| Fax |
|
| Email |
pi@vivotechresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Badrinath Sangle |
| Designation |
Director |
| Affiliation |
Vivotech Research Private Limited |
| Address |
Plot no D17 4 TTC Industrial Area Turbhe MIDC Navi Mumbai 400703 India
Plot no D17 4 TTC Industrial Area Turbhe MIDC Navi Mumbai 400703 India
Thane
MAHARASHTRA
400703
India |
| Phone |
9930646601 |
| Fax |
|
| Email |
badrinath@vivotechresearch.com |
|
|
Source of Monetary or Material Support
|
| AKUMS DRUGS & PHARMACEUTICALS LTD,Plot No.131 to 133, Block –C, Mangolpuri Industrial
Area, Phase-I (Adjoining CBSE Office),
Delhi -110083, India. |
|
|
Primary Sponsor
|
| Name |
AKUMS DRUGS & PHARMACEUTICALS LTD |
| Address |
First floor CT Dept Plot No.131 to 133, Block –C, Mangolpuri Industrial Area, Phase-I (Adjoining CBSE Office), Delhi -110083, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AKUMS DRUGS PHARMACEUTICALS LTD |
19-21, Sector 6A, IIE, SIDCUL, Ranipur, Haridwar - 249403, Uttarakhand |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrikant Vishnu Deshpande |
Ashirwad Hospital and Research Centre, |
Clinical Research Dept, Maratha Section, Near Jijamata Udyan, Ulhasnagar, Thane, Maharashtra-421004
Thane
MAHARASHTRA |
9822017445
writetoshrikant@rediffmail.com |
| Dr Mahendra Pal Singh |
G.S.V.M Medical College |
Swaroop Nagar, Kanpur-208002, U. P. India
Kanpur Nagar
UTTAR PRADESH |
8765379671
drmahendraoalsingh@gmail.com |
| Dr Dixit Subhal Bhalchandra |
MTESs Sanjeevan Hospital |
MTESs Sanjeevan Hospital,Clinical Research Dept, Plot No. 23, off Karve Road, Erandawane, Pune-411004
Pune
MAHARASHTRA |
9822050240
subhaldixit@yahoo.com |
| Dr Arijit Sinha |
NRS Medical College & Hospital |
Clinical Research Dept, 138, A.J.C. Bose Road, Kolkata-700014, West Bangal, India
Kolkata
WEST BENGAL |
9434016561
drarijitsinha66@gmail.com |
| Dr Niranjan Padhi |
Sparsh Hospital & Critical Care Pvt. Ltd |
Plot no. -A/407, Saheed Nagar, Bhubhaneshwar, Orissa-751007
Baleshwar
ORISSA |
9437167776
ninjapadhi2007@gmail.com |
| Dr Jyotsna S Jadhav |
Supe Heart And Diabetes Hospital & Research Centre |
Supe Heart And Diabetes Hospital, Clinical Dept, Opp. Adhar Asharam, Near Rungta School, Gharpure Ghat, Ashok Stambh Nashik, Maharashtra - 422002.
Nashik
MAHARASHTRA |
9890335393
dr.jyotsnajadhav11@gmail.com |
| Dr Rajvardhan Vijay Shelke |
Swastik Dhadiwal Hospital |
Swastik Dhadiwal Hospital, Clinical Dept, Opp. New CBS, Matoshree Nashik-422005, Maharashtra , India
Nashik
MAHARASHTRA |
9960536239
rajvardhanshelke@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ashirwad Ethics Committee |
Approved |
| Dr. Murlidhar Eye Hospital Ethics Committee |
Submittted/Under Review |
| Ethics Committee GSVM Medical College Kanpur |
Submittted/Under Review |
| Institutional Ethics Committee Nil Ratan Sircar Medical College & Hospital |
Submittted/Under Review |
| Kusum Independent Ethics Committee |
Approved |
| Shree Institutional Ethics Committee |
Approved |
| Supe Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of Drotaverine Hydrochloride IP 80 mg and Aceclofenac IP 100 mg Tablet |
One Tablet once daily for 1-3 days. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Subjects meeting following criteria will be included in the study:
1. All patients with duly filled in ICFs [Informed Consent Forms]
2. 18-45 years of age.
3. Diagnosis of the Colicky pain due to smooth muscle spasm/ visceral colic like primary
dysmenorrhea, biliary colic and ureteric colic. |
|
| ExclusionCriteria |
| Details |
Subjects will be excluded from the study for any of the following reasons:
1. Patients unwilling to sign on ICF
2. Participation in other trials,
3. Concomitant therapy,
4. Pregnancy or breast feeding,
5. Inadequate contraception,
6. Dementia,
7. Alcohol or drug dependence,
8. Concomitant serious medical condition.
9. Hypersensitivity to Drotaverine or Aceclofenac,
10. Fever,
11. Pituitary disease, and
12. Concomitant use of sex hormones except oral contraceptives for which the doses will be
unchanged.
13. Any other serious diseases having fatal progression.
14. Any of the following endocrinological diseases: diabetes mellitus, hypo- /hyperthyreosis,
pituitary tumor.
15. Clearly kidney or liver disease, abnormal kidney or liver function. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the safety profile of Fixed-dose combination tablets of Drotaverine 80 mg and Aceclofenac 100 mg in patients with Colicky pain due to smooth muscle spasm. |
Baseline, Visit 2 & Visit 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy profile of Fixed-dose combination tablets of Drotaverine 80 mg and Aceclofenac 100 mg in patients with Colicky pain due to smooth muscle spasm. |
Baseline, Visit 2 & Visit 3 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
12/05/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This Multicenter, Open-label, Single-arm Post-Marketing Surveillance (PMS) study evaluates the Fixed-Dose Combination (FDC) of Drotaverine 80 mg and Aceclofenac 100 mg in patients with colicky pain due to smooth muscle spasm. Patients will receive one tablet once daily for 2-3 days, with assessments conducted at screening, enrollment, and end-of-study visits. The primary objective is to assess the safety profile, while the secondary objective is to evaluate the efficacy of the combination therapy. Key endpoints include adverse event incidence, quality of life changes, pain severity reduction, and Physician’s Global Assessment of treatment response. |