Tapentadol Tablets in the Management of Acute Low Back Pain.

Phase 3

• Conditions: Acute Low Back Pain

• Registration Number: CTRI/2010/091/001412
• Lead Sponsor: Hetero Labs Limited

Brief Summary

1. Comparative, Randomized, Double Blind, Parallel, Multicentric Study for Efficacy and Safety of Tapentadol Versus Tramadol In the Management of Acute Low Back Pain. 2. The proposed number of subject to be enrolled in to the study is 300 (this number includes the Screening) and data will be submitted 200 completed patients. Study population will comprise of Patients with Acute Low Back Pain. 3. The recommended dose of Tapentadol 50mg tablets in comparison with Tramadol in the dose of 50mg t.i.d daily for 0,3,7 days. 4. The primary efficacy outcome will be Improvement in 1) pain (i.e. pain relief) (VAS), 2) modified Oswestry low back pain disability index (ODI) and 3) finger to floor distance from baseline and The Secondary outcome is Global assessment by physician and patient.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

• 1.Male or female patients2.Age between 20-65 years3.Willing to give written informed consent and willing to comply with study protocol.
• 4.Patients with acute or relapsing LBP moderate to severe intensity.
• 5.Patients with at least 40 mm pain intensity on VAS scale 6.Patient and / or physician?s global assessment of arthritic condition as fair, poor or very poor.
• 7.Patients not on any anti-inflammatory or other therapy for the past 2 weeks known to affect the study outcome.

Exclusion Criteria

1.Pregnant and lactating women2.Patients with H/O any drug allergy 3.Severe spinal disease like spondylitis, fractures, cancer, severe arthrosis and osteoporosis.4.Muscle diseases such as myositis, polymyositis, muscular dystrophy and myotony.5.Unwilling to comply with the protocol requirements6.H/o skin lesions, skin ulcers.7.Patients with gastro-intestinal disease, peptic ulcer, bleeding disorder and faecal blood loss8.Patients with cardiac, hepatic and renal dysfunction and haemopoetic disorder9.Patients with hypertension10.Patients deemed ineligible by the investigator.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in 1) pain (i.e. pain relief) (VAS), 2) Modified oswestry low back pain disability index (ODI) and 3) finger to floor distance from baseline.	0,3,7 days

Secondary Outcome Measures

Name	Time	Method
The Secondary outcome is Global assessment by physician and patient.	0,3,7 days

Trial Locations

Locations (10)

Aakarsh Orthopedic Hospital; 🇮🇳 Nellore, ANDHRA PRADESH, India

Abhishek Hospital; 🇮🇳 Vadodara, GUJARAT, India

Bassi Nursing Home Pvt. Ltd,; 🇮🇳 Ludhiana, PUNJAB, India

Clinic; 🇮🇳 Jaipur, RAJASTHAN, India

GSVM Medical College; 🇮🇳 College, India

Hyma Hospitals; 🇮🇳 Guntur, ANDHRA PRADESH, India

King George Hospital; 🇮🇳 George, India

Parvati Jadav Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

SVNIRTAR; 🇮🇳 Cuttack, ORISSA, India

Trisha Trauma Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Aakarsh Orthopedic Hospital

🇮🇳Nellore, ANDHRA PRADESH, India

Dr.D.Narayana Reddy

Principal investigator

narayanareddyduvvuru@yahoo.co.in