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CTRI Number  CTRI/2024/11/077285 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 21/11/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A phase IV clinical trial to compare the effectiveness and safety of two formulations of drotaverine in patients with spasmodic pain. 
Scientific Title of Study   A prospective, randomized, investigator initiated, assessor blinded, active controlled, single centre, phase IV clinical trial to compare the efficacy and safety of two different formulations of drotaverine in patients with spasmodic pain. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
IIS/CP/01 Version 00 Dated 06/11/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jayesh Sanmukhani  
Designation  Head – Medical Services 
Affiliation  Clinexcel Research 
Address  297 / 301, 2nd floor, Clinical research room, SoBo Centre, South Bopal,

Ahmadabad
GUJARAT
380058
India 
Phone  7600012192  
Fax    
Email  drjayesh@clinexcelresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayesh Sanmukhani  
Designation  Head – Medical Services 
Affiliation  Clinexcel Research 
Address  297 / 301, 2nd floor, Clinical research room, SoBo Centre, South Bopal,

Ahmadabad
GUJARAT
380058
India 
Phone  7600012192  
Fax    
Email  drjayesh@clinexcelresearch.com  
 
Details of Contact Person
Public Query  
Name  Dr Jayesh Sanmukhani  
Designation  Head – Medical Services 
Affiliation  Clinexcel Research 
Address  297 / 301, 2nd floor, Clinical research room, SoBo Centre, South Bopal,

Ahmadabad
GUJARAT
380058
India 
Phone  7600012192  
Fax    
Email  drjayesh@clinexcelresearch.com  
 
Source of Monetary or Material Support  
Investigator Initiated Study (5, Anveshan Row House, Opp. Umiya Mata Mandir, Bopal-Ghuma Main Road, Bopal, Ahmedabad, 3800058, Gujarat, India :Dr. Chintan Patel) 
 
Primary Sponsor  
Name  Dr. Chintan Patel 
Address  5, Anveshan Row House, Opp. Umiya Mata Mandir, Bopal-Ghuma Main Road, Bopal, Ahmedabad, 3800058, Gujarat, India. 
Type of Sponsor  Other [[ Self (Principal Investigator) ]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chintan Patel  Aatman Hospital  Basement, Clinical Research Department, Aatman Hospital 5, Anveshan Row House, Opp. Umiya Mata Mandir, Bopal-Ghuma Main Road, Bopal, Ahmedabad, 3800058
Ahmadabad
GUJARAT 		 9825182251

drchintan.cr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Aatman Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R52||Pain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional formulation of Drotaverine 40mg  single oral dose of 40mg tablets (once only ; single dose study) 
Intervention  New formulation of Drotaverine 40mg  single oral dose of 40mg tablets (once only ; single dose study) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of either gender between 18-65 years of age (both inclusive)
2. Patients with a confirmed clinical diagnosis of acute spasmodic pain (e.g., renal colic, gastrointestinal spasms, or acute primary dysmenorrhea)
3. Patients with baseline pain intensity rated as moderate to severe (≥40 mm) on the VAS
4. Patients willing to remain in the clinical setup for at least 6 hours after the administration of the study medication for continuous monitoring and follow-up.
5. Patients willing to provide written informed consent and comply with the protocol requirements. 
 
ExclusionCriteria 
Details  1. Patients who have received any of the following analgesics, opioids, or pain-relieving supplements (including topical, herbal, or other supplementary therapies) within the stipulated time frames:
a. Acetaminophen/Paracetamol (PCM): Within 8 hours before screening.
b. Drotaverine: Within 48 hours before screening.
c. Opioid Analgesics: Within 7 days before screening.
d. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):
i. Aspirin: Within 5 half-lives or 5 days (whichever is longer) before screening.
ii. Topical NSAIDs (e.g., Diclofenac gel): Within 48 hours before screening.
iii. Other NSAIDs (e.g., ibuprofen, naproxen): Within 5 half-lives or 5 days before screening.
e. Local Anesthetics: (e.g., lidocaine patches, topical lidocaine creams) within 48 hours before screening.
f. Herbal or Supplementary Pain-Relief:
i. Herbal remedies (e.g., turmeric, ginger, willow bark) taken orally or topically within 7 days before screening.
ii. Topical pain-relief products (e.g., capsaicin, menthol-based creams) applied within 7 days before screening.
g. Other Medications:
i. Muscle relaxants (e.g., baclofen, cyclobenzaprine): Within 72 hours before screening.
ii. Corticosteroids (e.g., oral or injected corticosteroids): Within 14 days before screening.
2. Patients with known hypersensitivity or allergy to drotaverine or any component of the study drug.
3. Patients with a known history of significant hepatic, renal, or cardiovascular conditions, uncontrolled diabetes, or other major medical conditions that could interfere with the study.
4. Patients with non-spasmodic chronic pain, such as neuropathic pain.
5. Patients with a history of drug or alcohol abuse that may interfere with the interpretation of study results.
6. Pregnant or lactating females.
7. Patients unwilling to comply with study requirements.
8. Any other reason for which the investigator feels that the patient should not participate.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Sum of Pain Intensity Difference over 6 hours (SPID-6) in the two arms using the VAS.  from baseline(0 hour) to 6 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Mean Pain Intensity Difference (mPID) measured in the two arms using the VAS.  at 15, 30, 45, 60 minutes, and at 1.5, 2, 3, 4, 5, and 6 hours post-dose from baseline(0 hour) 
Percentage of patients achieving ≥50% pain relief or Total Pain Relief (TOTPAR) in the two arms based on VAS.  at 6 hours post-dose from baseline(0 hour) 
Percentage of patients perceived onset of pain relief in the
two arms. 		 at less than 15 minutes, between 16-30 minutes, 31 to 60 minutes, more than 60 minutes post-dose from baseline(0 hour) 
Proportion of patients withdrawn and given rescue medication in lack of response to the treatment.   during 6 hours post-dose 
Number of Adverse events reported into the study  Baseline to end of study 
Number of Serious Adverse events reported into the study  Baseline to end of study 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   02/12/2024 
Date of Study Completion (India) 12/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   In this study, patients with established diagnosis of acute spasmodic pain including renal colic, gastrointestinal spasms, or acute primary dysmenorrhea requiring treatment with drotaverine will be screened and enrolled if found eligible. All the eligible patients will be followed up for at least 6 hours after the administration of the study medication for continuous monitoring. Initial evaluations will occur at Assessment 1 (Screening & Dosing) to establish baseline parameters. Subsequent assessments, Assessment 2 to 9, will be conducted at 15, 30, 45, and 60 minutes, then at 1.5, 2, 3, 4, and 5 hours post-dosing, with the final Assessment 10 (End of Study) concluding the study period. This will be a two-arm study and all the enrolled patients will be instructed to take the study medication as directed.  
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