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CTRI Number  CTRI/2015/05/005796 [Registered on: 21/05/2015] Trial Registered Retrospectively
Last Modified On: 21/05/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of use of Drotaverine Hydrochloride and Mefenamic Acid vs Mefenamic Acid in mensturating females 
Scientific Title of Study   Efficacy and Safety of Fixed Dose Combination of Drotaverine Hydrochloride (80 Mg) and Mefenamic Acid (250mg) Versus Mefenamic Acid (250mg) alone In The Treatment Of Primary Dysmenorrhea: Double-Blind, Randomized comparative study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr J B Sharma 
Designation  Additional Professor 
Affiliation  All India Institute of Medical sciences 
Address  Room No 3082 III Floor Teaching Block Department of Obstetrics and Gynaecology

New Delhi
DELHI
110029
India 
Phone  9868397309  
Fax    
Email  jbsharma2000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr J B Sharma 
Designation  Additional Professor 
Affiliation  All India Institute of Medical sciences 
Address  Room No 3082 III Floor Teaching Block Department of Obstetrics and Gynaecology


DELHI
110029
India 
Phone  9868397309  
Fax    
Email  jbsharma2000@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr J B Sharma 
Designation  Additional Professor 
Affiliation  All India Institute of Medical sciences 
Address  Room No 3082 III Floor Teaching Block Department of Obstetrics and Gynaecology


DELHI
110029
India 
Phone  9868397309  
Fax    
Email  jbsharma2000@gmail.com  
 
Source of Monetary or Material Support  
Walter Bushnell Private Limited 
 
Primary Sponsor  
Name  Walter Bushnell Private Limited 
Address  Apeejay Stya House 14 Commercial Complex Masjid Moth Greater Kailash 2 New Delhi 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 J B Sharma  All India Institute of Medical Sciences  Department of Obstetrics and Gynaecology
New Delhi
DELHI 		 9868397309

jbsharma2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Primary Dysmenorrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Drotaverine hydrochloride with Mefenamic acid  Drotaverine hydrochloride (80mg) and mefenamic acid (250mg) t.i.d orally for three days in the investigational group 
Comparator Agent  Mefenamic Acid alone  mefenamic acid (250 mg) alone t.i.d orally for a maximum of three days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Patients with regular menstruation (28 ± 7 day cycle)
Patients with history of primary dysmenorrhoea
Patients ready to follow-up 
 
ExclusionCriteria 
Details  Failure to meet all inclusion criteria
Causes of secondary dysmenorrhea including endometriosis, pelvic inflammatory disease, adenomyosis, fibroids (myomas), endometrial polyps, cervical stenosis (after uterine or cervical surgery), functional ovarian cysts, benign or malignant tumors of ovary, bowel or bladder, or other site, Inflammatory bowel disease
Pregnant and lactating women
Any pelvic abnormality on physical examination including infection or inflammatory process
Premenstrual syndrome (PMS), infertility, heavy menstrual flow or irregular cycles, dyspareunia
Any previous clinical history of gastroduodenal ulcer, gastrointestinal bleeding, or gastroduodenal perforation
Concomitant use of medications that are known to increase the likelihood of upper gastrointestinal adverse events (e.g. corticosteroids and anticoagulants)
Presence of serious co-morbidity, such as cardiovascular disease, cerebrovascular disease, renal or hepatic impairment, history of venous disease, diabetes, or hypertension
Patients with history of hypersensitivity to NSAID and/or drotaverine
Women will also be excluded if they had used an intrauterine device or oral contraceptives within six months prior to the study and had received NSAIDs or analgesics within 48 h prior to study entry
Patients participating in any other clinical trial 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of pain relief at different time intervals i.e 15, 30 minutes, 1, 2, 4, 8, 12, 24 and 48 hours after the first dose of study medication
Total area under pain relief (PR) score up to 2, 4 and 8 hours (TOPAR/2, TOPAR/4 and TOPAR/8) 		 Assessment of pain relief at different time intervals i.e 15, 30 minutes, 1, 2, 4, 8, 12, 24 and 48 hours after the first dose of study medication
Total area under pain relief (PR) score up to 2, 4 and 8 hours (TOPAR/2, TOPAR/4 and TOPAR/8) 
 
Secondary Outcome  
Outcome  TimePoints 
Pain Intensity Difference
Sum of Pain Intensity Difference over 2, 4 and 8 hours
Peak PID over 2, 4 and 8 h
Peak PR over 2, 4 and 8 h
Total study drug consumption
Patient’s and investigator’s global evaluation of the efficacy 		 Pain Intensity Difference
Sum of Pain Intensity Difference over 2, 4 and 8 hours
Peak PID over 2, 4 and 8 h
Peak PR over 2, 4 and 8 h
Total study drug consumption
Patient’s and investigator’s global evaluation of the efficacy 
 
Target Sample Size   Total Sample Size="280"
Sample Size from India="280" 
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   Phase 4 
Date of First Enrollment (India)   01/01/2015 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is a prospective, randomized, comparative, active‐controlled, two arm, parallel group, double blind study to compare traditional mefenamic acid (250 mg) alone versus combination of fixed dose combination of drotaverine hydrochloride (80 mg) and mefenamic acid (250 mg) to know whether addition of drotaverine provides any benefit to the patients in their relief from dymenorrhoea or the two drugs are equally effective. If it is proven that the addition of antispasmodic drug drotaverine to the traditional drug mefenamic acid (antiprostaglandin) , it will be an addition to the knowledge on this important and common subject and the same drug combination can be recommended to be prescribed to the patients. The present study will evaluate the efficacy and safety of fixed dose combination of Drotaverine Hydrochloride (80 Mg) and Mefenamic Acid (250mg) versus Mefenamic Acid (250mg) alone in the treatment of Primary Dysmenorrhea. Primary Efficacy Endpoints are assessment of pain relief at different time intervals after the first dose of study medication on an 11-point numerical rating scale and total area under pain relief (PR) score up to 2, 4 and 8 hours (TOPAR/2, TOPAR/4 and TOPAR/8).Safety and tolerability will be assessed by recording incidence of adverse events and serious adverse events. The study will be conducted at the department of Obstetrics & Gynaecology, All India Institute of Medical Sciences, New Delhi, India. A total of 280 patients will be enrolled in the study.

 
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