| CTRI Number |
CTRI/2017/09/009946 [Registered on: 28/09/2017] Trial Registered Prospectively |
| Last Modified On: |
27/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of safety and efficacy of fixed dose combination of tramadol and dicyclomine and acetaminophen in management of pain |
|
Scientific Title of Study
|
Prospective Open-Label Non Comparative Multi-Center Phase IV trial to evaluate the safety and efficacy of Spasmoproxyvon Plus capsules, a fixed dose combination of Tramadol 50mg and Dicyclomine 10mg and Acetaminophen 325mg of Wockhardt limited in management of severe acute spasmodic pain |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| WOC/SPA/CT-41/14 ver 1 date 05 Aug.2014 amt 2; 20.08.2019 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Khokan Debnath |
| Designation |
Senior General Manager (Head) – RA, Clinical Operations, PV and QA (India and Emerging Market) |
| Affiliation |
Wockhardt Ltd. |
| Address |
Wockhardt Towers, Bandra Kurla Complex, Bandra – 400 051,
Mumbai
Mumbai
MAHARASHTRA
400051
India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596407 |
| Fax |
|
| Email |
kdebnath@wockhardt.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr. Purushotham |
| Designation |
Medical Monitor |
| Affiliation |
Wockhardt Ltd. |
| Address |
Wockhardt Towers Bandra Kurla Complex Bandra – 400 051
Mumbai
Mumbai
MAHARASHTRA
400051
India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596447 |
| Fax |
|
| Email |
purushothamVS@wockhardt.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Kaushal Kapadia |
| Designation |
Manager Clinical Operations |
| Affiliation |
Wockhardt Ltd. |
| Address |
Wockhardt Towers, Bandra Kurla Complex, Bandra – 400 051,
Mumbai
Mumbai
MAHARASHTRA
400051
India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596445 |
| Fax |
|
| Email |
KKapadia@wockhardt.com |
|
|
Source of Monetary or Material Support
|
| Wockhardt Limited
Wockhardt Towers
Bandra Kurla Complex,
Bandra East, Mumbai - 400051 |
|
|
Primary Sponsor
|
| Name |
Wockhardt Limited |
| Address |
Wockhardt Towers Bandra Kurla Complex Mumbai – 400 051 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lata Bhoir |
B J Government Medical College and Sassoon General Hospital |
Dept of Surgery, B J Govt medical college and sassoon general hospital, near Pune Railway Station, pune 411001
Pune
MAHARASHTRA |
9552189336
lbhoir03@gmail.com |
| Dr Pankaj Yaduvanshi |
Dr. N M Saboo Memorial Hospital and Research Centre |
95, Arya Nagar, Near Mataji Temple, Kedia Palace Chouraha, Murlipura Jaipur 302039
Jaipur
RAJASTHAN |
9828022591
drpankajyaduvanshi1978@gmail.com |
| Dr Amol Wagh |
Grant Govt. Medical College and Sir J.J. Group of Hospitals |
Department of pharmacology, first floor, J J Hospital, Byculla, Mumbai 400008.
Mumbai
MAHARASHTRA |
9820685368
dramolwagh@gmail.com |
| Dr Brijal Patel |
Hansa Clinic and Hospital |
Amalia - Dabhel, Vapi-Daman road, somnath, Daman, Daman and Diu, 396215
Daman
DAMAN & DIU |
9909015179
hansahospital.cr@gmail.com |
| Dr Pawan Kumar Gangwal |
Imperial Hospital and Research Centre |
56-A, Near Kanwatia Circle, Shashtri Nagar, Jaipur - 302016, Rajasthan India
Jaipur
RAJASTHAN |
9782640746
drgangwalp@gmail.com |
| Dr Badal Kumar Sahu |
Nil Ratan Sircar Medical College and Hospital |
Department of General Medicine, 138, AJC Bose Road, Kolkota 700014, West Bengal, India
Kolkata
WEST BENGAL |
8240184543
drbadal08@gmail.com |
| Dr L N Mittal |
Priyadarshani Nursing Home |
M-Baria Estate, Kargil Road, Opp. Malvel pada talao, Virar East, Palgarh 401305
Mumbai (Suburban)
MAHARASHTRA |
9821182559
lnmittal311@gmail.com |
| Dr P Prabu Sankar |
Shanmuga Hospital Pvt Ltd |
51/24, Shanmuga Hospital Building, Saradha college road, Salem, 636007
Salem
TAMIL NADU |
8754004099
srprabusankar@smrft.org |
| Dr Deepak Varade |
Shree Ashirwad Hospital |
C-3/4, Shree Complex, Opp. Mahavir nagar, Manpada Road, Dombivali East, 421201
Mumbai (Suburban)
MAHARASHTRA |
9870409142
deepak.varade@gmail.com |
| Dr Prasad Nikam |
Surya Multispeciality Hospital |
Surya Arcade, 2nd floor, opp nimani bus stand, panchavati, Nashik 422003
Nashik
MAHARASHTRA |
9922999902
drprasadnresearch@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Altezza Institutional Ethics Committee |
Approved |
| HCH Institutional Ethics Committee |
Approved |
| IEC of B.J.G.M.College and Sassoon General Hospital |
Approved |
| Imperial Hospital Ethics Committee |
Approved |
| Institutional Ethics Committee New healthcare Nursing Home |
Approved |
| Institutional Ethics Committee Nilratan Sircar Medical College & Hospital |
Approved |
| Institutional Ethics Committee Sir JJ Group of Hospitals |
Approved |
| Leelavati Ethics Committee |
Approved |
| Marudhar Hospital Ethics Committee |
Approved |
| SMRFT Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients suffering from severe acute spasmodic pain due to dysmenorrhea or renal or ureteric colic or biliary colic or intestinal and other abdominal colic , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Spasmoproxyvon Plus capsules |
Fixed dose combination of Tramadol 50mg and Dicyclomine 10mg and Acetaminophen 325mg of Wockhardt limited |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subject should meet all of the below mentioned inclusion criteria for enrollment,
1. Patients of either sex aged between 18 to 65 years (inclusive)
2. Patients clinically diagnosed with severe acute spasmodic colicky pain (pain score ≥ 70 on VAS) due to dysmenorrhea, renal/ureteric colic, biliary colic, intestinal and other abdominal colic.
3. Subjects who understand the nature of trial and provide written informed consent for the trial
4. Subjects who are willing to comply with protocol procedures
|
|
| ExclusionCriteria |
| Details |
Subjects will not be eligible for enrollment in the study if a subject meets any of the following criteria,
1. Patients with known hypersensitivity to any of the content of study medication i.e., Tramadol or dicyclomine and paracetamol.
2. Patients who have taken an antispasmodic agent within 7 days before enrollment in the study.
3. Patients with history of pathological conditions of the intestine including inflammatory bowel disease or malabsorption syndromes or gastrointestinal malignancy or gastric or intestinal surgery including vagotomy or Barretts esophagus or scleroderma confirmed by endoscopic Gastric mucosal biopsy specimens for ulcers.
4. Patients with signs of significant or massive GI bleeding.
5. Patients with severe renal disorder.
6. Patients with a history of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
7. Patient with history of glaucoma and Myasthenia
8. Patient with history of acute pancreatitis and biliary disorder other than colicky pain
9. Patient with history of any other psychiatric or other chronic diseases that will prevent compliance with the study protocol.
10. Patient with history of asthma and patients with risk of respiratory depression.
11. History or evidence of significant cardiovascular disease, any malignancy, thyroid dysfunction, epilepsy, alcohol or drug abuse or any other medical condition that in the opinion of Investigator can interfere with the study treatment.
12. Women of child-bearing potential who are pregnant or lactating or not following adequate contraceptive measures.
13. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety assessments including adverse events (AEs) and serious adverse events (SAEs). |
safety assessment would be done at the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean Change in VAS from baseline to end of treatment, Proportion of patients showing ≥ 50% improvement in baseline VAS pain score over end of treatment, Onset of analgesia, Duration of analgesia, Time required for analgesia, No. of study medication consumed to achieve analgesia, Physician’s and patient’s global evaluation, No. of rescue medication used |
The assessment would be done at end of the study treatment |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "503"
Final Enrollment numbers achieved (India)="503" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
29/09/2017 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study will be a prospective, open-label, non
- comparative, multi-center, phase IV trial to evaluate the safety and efficacy
of Spasmoproxyvon Plus
capsules (FDC of Tramadol 50mg + Dicyclomine 10mg + Acetaminophen 325mg) of
Wockhardt limited India, in subjects with severe acute spasmodic pain
due to colic (dysmenorrhea, renal/ureteric colic, biliary colic, intestinal and
other abdominal colic). Assessment
of efficacy will be determined based on Clinical i.e. it will be symptomatic
relief in severity of colicky abdominal pain using Visual Analog Scale (0-100)
Clinical response will be the secondary endpoint in
this study. Clinical assessment will be made on the basis of improvement in the
Visual Analog Scale (0-100) finding from baseline.
A
patient is considered a cure if signs and symptoms related to colicky abdominal
pain are resolved or clinical improvement was such that there was relief in
severity of pain during overall treatment period All
subjects who received at least one dose of study drug shall be included in the
safety analysis. All subjects in the study will be monitored for any adverse
events and serious adverse events |