| CTRI Number |
CTRI/2009/091/001051 [Registered on: 22/12/2009] |
| Last Modified On: |
22/11/2018 |
| 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
Modification(s)
|
A clinical Trial in-patients Acute Pain associated with Muscle Spasm and
Inflammatory Conditions. Clinical trial is to study efficacy, safety and tolerability of Flupirtine maleate capsule 100 mg (Mfg. By Ajanta Pharma) in comparison to Flupirtine maleate capsule 100 mg (reference product). |
Scientific Title of Study
Modification(s)
|
A Comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Flupirtine maleate capsule 100 mg (Mfg. By Ajanta Pharma) Vs. Flupirtine maleate capsule 100 mg in Acute Pain associated with Muscle Spasm and Inflammatory Conditions. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| AJ/SC/07/2009 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. S.Somshekar |
Deeksha Hospital |
387/347, Next to Post Office,B B Road, Nehrunagar, Yelahanka Old Town-560 064
Bangalore
KARNATAKA |
0 9845351508
drshekarortho@gmail.com |
| Dr V M Parthasarathy |
New Hope Medical Centre |
814, Poonamallee High road kilpauk, Chennai 600010.
Chennai
TAMIL NADU |
044-26412230
vmpsarathy1942@yahoo.co.in |
| Dr V Veerappan |
Pondy Ortho Clinic |
No.2, Mohan Nagar,100 Feet Road, Near Rajiv Gandhi Statue,-605005
Pondicherry
PONDICHERRY |
09443373462
drveerppan3@rediffmail.com |
| Dr Rajesh Upadhyaya |
Upadhyaya Nursing Home |
Moiz Apt, 12th Road,Opp Reliance Energy, Santacruz (E)-400055
Mumbai
MAHARASHTRA |
022-26140223
022-26112409
unh_moiz@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| IEC , 4 Sharavati, worli sea face, Worli, Mumbai 400025 |
Approved |
| IEC of Deeksha Hospital, 387/347,Next to post office, B B Road, Nehrunagar,Yelahanka Old towen,Bangalore 560064 |
Approved |
| IEC of New hope Medical centre,814, Poonamallee High road kilpauk,Chennai 600010. |
Approved |
| IEC of Vijay Hospital, E.C.R (Bye pass) Lawspet, Poundicherry-8 |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Acute Pain associated with Muscle Spasm and Inflammatory Conditions, (1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Flupirtine maleate capsule 100 mg |
Three Capsules Daily for a period 7 days |
| Intervention |
Flupirtine maleate capsule 100 mg (Mfg. By Ajanta Pharma) |
Three Capsules Daily for a period 7 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Day(s) |
| Gender |
Both |
| Details |
1. Clinical diagnosis of Tinea pedis and Tinea cruris confirmed by laboratory evaluation (microscopic examination confirmed by a positive potassium hydroxide test).
2.Written informed consent by patient.
3.Patient willing to follow up.
. |
|
| ExclusionCriteria |
| Details |
1.Pregnant or nursing females.
2.Patient with impaired hepatic function defined as SGOT or SGPT 2.0 times the upper limit of the normal
3.Patient with impaired renal function, confirmed by serum creatinine 2.0 mg/dL
4.Patient who had participated in a medical, surgical or pharmaceutical investigation at the time of the study in which an investigational new drug was dispensed to the patient within last 6 months
5.Patient with history of hypersensitivity of Flupirtine and any topical analgesic preparations like balm, gel etc
6.Patients with Bile Outflow Disorders.
7.Patients with alcoholic abuse. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pharmacy-controlled Randomization |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Changes in Restriction of Movement Score |
Day 0, Day 3, Day 5 and Day 7. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Improvement in Patients and Physicians Global Assessment of Pain |
Day 7 |
| Changes in Symptoms such as Stiffness, Swelling, Tenderness and Redness shall be evaluated at baseline and each visit |
Day 0, Day 3, Day 5 and 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
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
17/02/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="2"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a a prospective, randomized, comparative, double blind and Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Flupirtine maleate capsule 100 mg (Mfg. By Ajanta Pharma) Vs Flupirtine maleate capsule 100 mg (Reference Drug), for 7 days in 200 patients with acute pain associated with muscle spasm and inflammatory conditions. The study will start on 17 February 2010.
Primary efficacy endpoints are visual analog scale (VAS) score for pain and changes in restriction of movement score which will be measured on day 0, 3, 5 and 7. Secondary efficacy endpoint are changes in symptoms such as Stiffness, Swelling, Tenderness and Redness (will be measured on day 0, 3, 5 and 7) and improvement in patients and physicians global assessment of pain at day 7.
|