| CTRI Number |
CTRI/2012/11/003107 [Registered on: 14/11/2012] Trial Registered Retrospectively |
| Last Modified On: |
18/01/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Thoicolchicoside Oral Spray in Acute Non Specific Low Back Pain |
|
Scientific Title of Study
|
A clinical study to compare efficacy and safety of test product Thiocolchicoside Oral
Spray with Reference Product Myoril 8 mg capsules in patients with Acute Non Specific Low Back Pain |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| LINC/CT/011/11 version 00 dated 19-05-2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Hiren Patel |
| Designation |
Sr. Research Scientist |
| Affiliation |
Lincoln Pharmaceuticals Ltd. |
| Address |
LINCOLN PHARMACEUTICALS LTD. (R&D)
10,12,13, Trimul Estate,
Nr. Khatraj Chokadi, Talu.:Kalol
Po.: Khatraj.
Gandhinagar
GUJARAT
382721
India |
| Phone |
09825800168 |
| Fax |
|
| Email |
hiren.rnd@lincolnpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Hiren Patel |
| Designation |
Sr. Research Scientist |
| Affiliation |
Lincoln Pharmaceuticals Ltd. |
| Address |
LINCOLN PHARMACEUTICALS LTD. (R&D)
10,12,13, Trimul Estate,
Nr. Khatraj Chokadi, Talu.:Kalol
Po.: Khatraj.
Gandhinagar
GUJARAT
382721
India |
| Phone |
09825800168 |
| Fax |
|
| Email |
hiren.rnd@lincolnpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Hiren Patel |
| Designation |
Sr. Research Scientist |
| Affiliation |
Lincoln Pharmaceuticals Ltd. |
| Address |
LINCOLN PHARMACEUTICALS LTD. (R&D)
10,12,13, Trimul Estate,
Nr. Khatraj Chokadi, Talu.:Kalol
Po.: Khatraj.
Gandhinagar
GUJARAT
382721
India |
| Phone |
09825800168 |
| Fax |
|
| Email |
hiren.rnd@lincolnpharma.com |
|
|
Source of Monetary or Material Support
|
| Lincoln Pharmaceuticals Ltd |
|
|
Primary Sponsor
|
| Name |
Lincoln Pharmaceuticals Ltd |
| Address |
LINCOLN PHARMACEUTICALS LTD.(R&D)
10,12,13, Trimul Estate,
Nr. Khatraj Chokadi, Talu.:Kalol
Po.: Khatraj-382721
Dist.:Gandhinagar |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrTejas Gandhi |
Arihant Fracture & Orthopaedic Hospital |
“Upnishad†3-First Floor, Above Hero
Honda Show Room, Under Shreyas
Crossing Flyover Bridge, Ambawadi,
Ahmedabad-380 015
Ahmadabad
GUJARAT |
9825289683
investigator.research1@gmail.com |
| DrGPDureja |
Delhi Pain Management centre |
B-2/18, Safdarjung Enclave,
New Delhi-110029, India
New Delhi
DELHI |
9810134924
gpdureja@gmail.com |
| DrNNTripathi |
Dr. Narendra Nath Tripathi clinic |
7-Devendrapuri,
Gurudwara road,
Lucknow, India.
Lucknow
UTTAR PRADESH |
9335231906
drs.tiwari@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Adarsh independent Ethics Committee, Ahmedabad |
Approved |
| Bio Ethics Forum of Lucknow, Lucknow |
Approved |
| Global Society for Ethical Research Ethics Committee (GSER), New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute Non Specific Low Back Pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Myoril 8 mg capsules (thiocolchicoside 8 mg) |
Dose and Duration: One capsule Two times daily for Seven consecutive days. |
| Intervention |
Thiocolchicoside Oral Spray (thiocolchicoside 8 mg per two squirts) |
Dose and Duration: Two squirts Two times daily for Seven consecutive days. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with either sex with the age between 16 and 70 years.
2. Non specific low back pain with an acute episode of recent onset (<48 hours) defined by average pain within the last 24 hours on the Visual Analogue Scale (VAS).
3. Ability to understand and comply with protocol requirements.
4. Patients who have signed and dated their written informed consent prior to initial of the study.
5. Low back pain of diagnosis category 1 (low back pain radiating no further than the knee), as defined by the International Paris Task Force on Back Pain. |
|
| ExclusionCriteria |
| Details |
1. Acute low back pain due to vertebral collapse or neoplastic, inflammatory (ankylosing spondylitis), or infective origins
2. Patients with psychiatric or mental diseases, or unable to follow the requests of the protocol
3. Positive history of cerebro-vascular accidents
4. Patients treated during two days prior to inclusion with steroidal agents.
5. Known or suspected hypersensitivity to thiocolchicoside.
6. Concomitant treatment with 2-agonists (i.e. clonidine).
7. Pregnant or breast feeding women.
8. Females of child bearing potential, not taking adequate contraception.
9. Patients with history of alcohol, drugs or narcotics abuse. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Average pain within the last 24 hours (VAS -I) at Day 1 (before starting treatment), Day 3 & Day 8 |
at Day 1 (before starting treatment), Day 3 & Day 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Pain on movement (VAS - II) at D1, D3 and D8
-Stiffness (Hand-to-floor distance) at D1, D3 and D8
-Disability (Roland Morris questionnaire) at D1, D3 and D8
-Patient perceived change after treatment (Global Perceived Effect, GPE) at D8 |
at Day 1 (before starting treatment), Day 3 & Day 8 |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/06/2012 |
| 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
|
Years="0"
Months="2"
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
|
It is an open
labelled, multicentre, randomized, comparative clinical phase III trial which
is going to compare the Efficacy and Safety of Test Product: Thiocolchicoside Oral Spray with
Reference Product Myoril 8 mg capsules in
patients with Acute Non Specific Low Back Pain. Total 220 patients (including
anticipated dropout of about 10%) will be recruited from three investigational
sites of India. The patients recruited into the study will receive
either two squirts of Thiocolchicoside Oral Spray two times a day or one Myoril
8 mg capsule two times a day as per randomization sheet for 7 consecutive days. The primary efficacy
criterion will be measured as Average pain within the last 24 hours (VAS -I) at
Day 1 (before starting treatment), Day 3 & Day 8. While secondary efficacy
criteria will be measured as Pain on movement (VAS - II) at D1, D3 and D8;
Stiffness (Hand to- floor distance) at D1, D3 and D8; Disability (Roland Morris
questionnaire) at D1, D3 and D8; Patient perceived change after treatment (Global
Perceived Effect , GPE) at D8.Safety
assessment will be done in terms of spontaneously reported and directly
observed adverse events (AEs) after administered dose until post treatment
follow up and suspected side effects observed throughout study.
|