None listed
Conditions
Interventions
Intervention1: Tapentadol 50mg: Tapentadol 50mg, t.i.d daily, Duration 0,3,7 days
Control Intervention1: Tramadol 50mg: Tramadol 50mg, t.i.d daily, Duration 0,3,7 days
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The Secondary outcome is Global assessment by physician and patient.Timepoint: 0,3,7 days | — |
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactB Mohan Reddy
NIMS
Outcome results
None listed