Tapentadol Tablets in the Management of Acute Low Back Pain.
- Registration Number
- CTRI/2010/091/001412
- Lead Sponsor
- Hetero Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1.Male or female patients
2.Age between 20-65 years
3.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.
1.Pregnant and lactating women
2.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 requirements
6.H/o skin lesions, skin ulcers.
7.Patients with gastro-intestinal disease, peptic ulcer, bleeding disorder and faecal blood loss
8.Patients with cardiac, hepatic and renal dysfunction and haemopoetic disorder
9.Patients with hypertension
10.Patients deemed ineligible by the investigator
Study & Design
- Study Type
- Interventional
- 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.Timepoint: 0,3,7 days
- Secondary Outcome Measures
Name Time Method The Secondary outcome is Global assessment by physician and patient.Timepoint: 0,3,7 days