| CTRI Number |
CTRI/2010/091/001138 [Registered on: 09/08/2010] |
| Last Modified On: |
21/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Control- Labeled, Prospective, Randomized, Parallel group, Multicentric, Phase III Clinical Trial to Evaluate Efficacy and Safety of Eperisone HCl SR 150mg OD Capsule compared with Eperisone HCl 50mg Tablet T.I.D in patients suffering from Acute Musculoskeletal Spasm associated with Low Back Pain. |
|
Scientific Title of Study
|
A Control- Labeled, Prospective, Randomized, Parallel group, Multicentric, Phase III Clinical Trial to Evaluate Efficacy and Safety of Eperisone HCl SR Capsule compared with Eperisone HCl Tablet in patients suffering from Acute Musculoskeletal Spasm associated with Low Back Pain. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NEX/INV/CTIII-7727/03/2010 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Deepak Bhambe |
| Designation |
|
| Affiliation |
|
| Address |
NARENDRA PRAKASH HEALTHCARE CLINICAL
DA/3-A,MAIN SHAKARPUR MARKET,OPP.NATHU SEETS.
New Delhi
DELHI
110092
India |
| Phone |
09654807949 |
| Fax |
|
| Email |
drdeepakbhambe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Amit Bhatt |
| Designation |
|
| Affiliation |
NEXUS CLINICAL RESEARCH (INDIA) LTD. |
| Address |
President & CEO
ANUJ PLOT NO-45,Ist FLOOR.MUMBAI PUNE HIGHWAY
Mumbai
MAHARASHTRA
400706
India |
| Phone |
022-27714204 |
| Fax |
|
| Email |
dramit.bhatt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gautam Saranath |
| Designation |
|
| Affiliation |
|
| Address |
General Manager,Inventia Healthcare Pvt Ltd.
A/505, Veera Industrial Estate, Off Infinity Mall, Andheri Link Road
Mumbai
MAHARASHTRA
400053
India |
| Phone |
+91-9987547061 |
| Fax |
|
| Email |
gautam.saranath@inventiahealthcare.com |
|
|
Source of Monetary or Material Support
|
| Inventia Healthcare Pvt. Ltd.
A/505, Veera Industrial Estate,
Off Infinity Mall, Andheri Link Road,
Andheri (W), Mumbai - 400 053.
|
|
Primary Sponsor
Modification(s)
|
| Name |
Inventia Health Care Pvt Ltd |
| Address |
505
VIP Plaza
Veera Industrial Estate
Link Road
Andheri W
Mumbai 400053 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahul Nehra |
Hope Hospital |
W.K.Road,Meerut-250001
Meerut
UTTAR PRADESH |
09837052678
rahulnehra2001@yahoo.co.in |
| Dr Deepak Bhambe |
Narendra prakash healthcare clinical |
Main Shakarpur market,opp.Nathu sweets laxminagar-110092
New Delhi
DELHI |
+91-9654807949
drdeepak.bhambe@gmail.com |
| DR. PRAKASH REGE |
REGE Clinic, B-1, 56/57/58, SUBHASH NAGAR |
TEEN DONGRI, M.G.ROAD,,GOREGAON (W), -400 062
Mumbai
MAHARASHTRA |
+91-9223477294
p_p_rege@yahoo.co.in |
| DR. TARSEM MOTTEN |
REGISTRAR DEPARTMENT OF ORTHOPEDIC |
Jammu Medical college and Hospital ,Bakshi Nagar -180002
Jammu
JAMMU & KASHMIR |
+91-9419101542
drtarsemmottem@yahoo.co.in |
| DR. TANURAJ SIROHI |
SIROHI CLINIC |
Chippi Tank,Meerut-250001
Meerut
UTTAR PRADESH |
09837020820
trsirohi@yahoo.com |
| DR. SATISH KUMAR GUPTA |
SOMDATT POLY CLINIC, |
S-524, SCHOOL BLOCK,laxmi Nagar-110092
New Delhi
DELHI |
+91-9811212494
kumar6511@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
| The Central Independent Ethics Committee- Clinical Research (India) |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Patient Suffering form Acute Musculoskeletal Spasm associated with Low Back Pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Eperisone |
50 mg three time a day for 7 days |
| Intervention |
Eperisone HCL SR |
150mg OD for 7 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex between 18 to 70 years of age.
Patients with confirmed diagnosis of Acute Musculoskeletal spasm with Low Back Pain due to:
Spondylosis deformans.
Prolapsed Intervertebral Disc (PID).
Muscle sprains with spasms.
Patients who are willing to take the medications as directed and willing to come for follow-ups.
Patients who are willing to comply with the protocol requirements.
Patients who are willing to give the written informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with other associated spasm conditions like traumatic pain with spasms, cervical spondylitis and pain and spasm associated with fractured bone.
Patients who had taken any form of skeletal muscle relaxant in the previous seven days
Patients with hypersensitivity to any of the ingredients of the study drug formulations.
Women of child bearing potential not following adequate contraceptive measures
Patients unwilling or unable to comply with the study procedures
Patients having a history of severe acute infection, major surgery, trauma, severe metabolic, endocrine or electrolyte disturbances and seizures in preceding eight weeks
Patients having severe hepatic insufficiency defined by an SGOT or SGPT value equal or higher than the three fold normal values of the respective laboratory reference value
Patients having any of the following disorders: Renal failure, Bulimia, Hypo and Hyperthyroidism, Nephrotic syndrome, Anorexia nervosa, biliary obstruction and severe cardiac dysfunction.
Patients having uncontrolled diabetes mellitus, or any other metabolic or endocrine disorder
Patients that have received treatment with any investigational drug in the preceding four weeks |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison percent of pain reduction within last 24 hours assessed using VAS at Day 4 in both treatment groups. |
day 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Average reduction in mean pain score within last 24 hours assessed using VAS by Investigator and Subject at Day7 i.e. completion of protocol treatment in both treatment groups. |
Day 7 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
24/07/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
The study will be conducted after obtaining written informed consent from the subjects. The subjects will undergo medical screening during pre-study visit (Visit 1). Screening will include complete clinical evaluation (medical history, physical examination, record of height, weight and vital signs). Female volunteers of child bearing capability will be subjected to a urine pregnancy test. Enrolled subjects will receive the medication for 4 days (Visit 2). At visit 3 efficacy and ADR evaluation will be done and medication for another 3 days dispensed. At visit 4 end of therapy efficacy, safety, tolerability and ADR monitoring will be done. The reduction inintensity of pain would be assessed by VAS and the safety evaluation would be done by analyzing the lab parameters (LFT and RFT). Subjects are allowed to visit to investigator at any time point during the study. |