A Control- Labeled, Prospective, Randomized, Parallel Group, Multicentric, Phase III Clinical trial to evaluate Efficacy and Safety of a FDC of Lornoxicam 16mg SR + Thiocolchicoside 16mg SR Tablet OD Compared with FDC Lornoxicam 8mg + Thiocolchicoside 8mg Capsule BID in Patients Suffering from skeletal Muscular spasm of any etiology.
- Conditions
- Patients Suffering form Skeletal Muscular spasm of any etiology
- Registration Number
- CTRI/2011/091/000010
- Lead Sponsor
- Alembic Ltd
- Brief Summary
The study will be conducted after obtaining written informed consent from the subjects. The subjects will undergo medical screening during pre-study visit (Visit 1). Screening will include complete clinical evaluation (medical history, physical examination, record of height, weight and vital signs). Female volunteers of child bearing capability will be subjected to a urine pregnancy test.Enrolled subjects will receive the medication for 1week (Visit 2). At visit 3 efficacy and ADR evaluation will be done. At visit 4 end of therapy efficacy, safety, tolerability and ADR monitoring will be done. Subjects are allowed to visit to investigator at any time point during the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
Non specific skeletal muscular spasm, with an acute episode Recent onset (<48 hours) defined by average pain and local immobility within the last 24 hours equal or more than grade 4 on the Visual Analogue Scale (VAS) Willing to give written informed consent.
- Acute pain due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination), such as neoplasm, infection or inflammatory disorders Low back pain of diagnosis category 3 (low back pain radiating beyond the knee, with no neurologic signs) or 4 (low back pain radiating to a precise and entire leg dermatome, with or without neurologic signs), as defined by the International Paris Task Force on Back Pain History of inflammatory arthritis of large joints, History of seizure disorders, History of malignant tumor, Treatment with steroidal agents (including aspirin) during the two days prior to prospective inclusion, prolonged used of corticosteroids, Treatment with NSAIDs or muscle relaxant or opioid analgesics within 3 days of admission, Psychiatric or mental diseases Immune Compromised HIV.
- Inclusion in another study in the past six months or previous inclusion in this study, History of alcohol, drugs or narcotics abuse Recent history of violent trauma, Constant progressive, non mechanical pain (no relief with bed rest), Thoracic pain, Patient systemically unwell, Unexplained weight loss, Widespread neurological symptoms (including Cauda equine syndrome), Structural deformity Fever, Clinical significant renal dysfunction defined by Creatinine > 1.5 UNL, Clinically significant hepatic dysfunction defined by: Total Bilirubin > 2 UNL SGOT (AST) > 1.5 UNL SGPT (ALT) > 1.5 UNL Patients who have received other therapy (physiotherapy, physical manipulations, invasive intervention, acupuncture therapy) within the last 48 hours.
- Pregnancy, breast feeding or women of childbearing potential not using efficient contraception.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison percent of pain reduction within last 24 hours assessed using VAS at Day 7 in both treatment groups. Baseline and completion of treatment
- Secondary Outcome Measures
Name Time Method Average reduction in mean pain score within last 24 hours assessed using VAS by Investigator and Subject at day 14 i.e. completion of protocol treatment in both treatment groups. Baseline and completion of treatment
Trial Locations
- Locations (5)
Dr Bhalla orthopedic clinic
🇮🇳Delhi, DELHI, India
Hope Hospital
🇮🇳200,,W.K.Road,-250, 001., India
Kolhe orthopedic centre
🇮🇳Road,, India
Mangalore Heart Centre
🇮🇳Bangalore, KARNATAKA, India
Narendra Prakash Health Care Centre
🇮🇳Delhi, DELHI, India
Dr Bhalla orthopedic clinic🇮🇳Delhi, DELHI, IndiaDR. SANDEEP BHALLAPrincipal investigator09891425123sbhalla22@gmail.com