Thoicolchicoside Oral Spray in Acute Non Specific Low Back Pain

Phase 3

Completed

• Conditions: Acute Non Specific Low Back Pain

• Registration Number: CTRI/2012/11/003107
• Lead Sponsor: Lincoln Pharmaceuticals Ltd

Brief Summary

It is an openlabelled, multicentre, randomized, comparative clinical phase III trial whichis going to compare the Efficacy and Safety of Test Product: Thiocolchicoside Oral Spray withReference Product Myoril 8 mg capsules inpatients with Acute Non Specific Low Back Pain. Total 220 patients (includinganticipated dropout of about 10%) will be recruited from three investigationalsites of India. The patients recruited into the study will receiveeither two squirts of Thiocolchicoside Oral Spray two times a day or one Myoril8 mg capsule two times a day as per randomization sheet for 7 consecutive days. The primary efficacycriterion will be measured as Average pain within the last 24 hours (VAS -I) atDay 1 (before starting treatment), Day 3 & Day 8. While secondary efficacycriteria 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 Morrisquestionnaire) at D1, D3 and D8; Patient perceived change after treatment (GlobalPerceived Effect , GPE) at D8.Safetyassessment will be done in terms of spontaneously reported and directlyobserved adverse events (AEs) after administered dose until post treatmentfollow up and suspected side effects observed throughout study.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-29
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Patient with either sex with the age between 16 and 70 years.
• 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).
• Ability to understand and comply with protocol requirements.
• Patients who have signed and dated their written informed consent prior to initial of the study.
• 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.

Exclusion Criteria

• 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.
• Known or suspected hypersensitivity to thiocolchicoside.
• Concomitant treatment with 2-agonists (i.e. clonidine).
• Pregnant or breast feeding women.
• Females of child bearing potential, not taking adequate contraception.
• Patients with history of alcohol, drugs or narcotics abuse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
-Pain on movement (VAS - II) at D1, D3 and D8	-Stiffness (Hand-to-floor distance) at D1, D3 and D8

Trial Locations

Locations (3)

Arihant Fracture & Orthopaedic Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Delhi Pain Management centre; 🇮🇳 Delhi, DELHI, India

Dr. Narendra Nath Tripathi clinic; 🇮🇳 Lucknow, UTTAR PRADESH, India

Arihant Fracture & Orthopaedic Hospital

🇮🇳Ahmadabad, GUJARAT, India

DrTejas Gandhi

Principal investigator

9825289683

investigator.research1@gmail.com