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
- Health Condition 1: null- Patients Suffering form Skeletal Muscular spasm of any etiology
- Registration Number
- CTRI/2011/091/000010
- Lead Sponsor
- Alembic Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- 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.Timepoint: 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.Timepoint: Baseline and completion of treatment