Efficacy Safety of a Combination Thiocolchicoside+Ketoprofen Compared to Thiocolchicoside Twice a Day for 7 Days in Patients Suffering From Acute Non Specific Low Back Pain
Summary
Primary Objective :
To demonstrate the superiority of the oral fixed - combination of a muscle relaxant, thiocolchicoside (TCC) to a non steroidal anti-inflammatory drug, ketoprofen, over oral TCC, on average pain within the last 24 hours in adults suffering from acute non specific low back pain with an episode of recent onset
Secondary Objective :
To compare the safety of the oral combination to that of oral TCC alone
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Low Back Pain
Intervention
Thiocolchicoside+Ketoprofen, Thiocolchicoside
Location
Sanofi-Aventis Administrative Office
Sao Paulo
Brazil
Status
Completed
Source
Sanofi-Aventis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00679146
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Failed Back Surgery Syndrome
A condition of persistent pain and discomfort in the BACK and the LEG following lumbar surgery, often seen in patients enrolled in pain centers.
Labor Pain
Pain associated with OBSTETRIC LABOR in CHILDBIRTH. It is caused primarily by UTERINE CONTRACTION as well as pressure on the CERVIX; BLADDER; and the GASTROINTESTINAL TRACT. Labor pain mostly occurs in the ABDOMEN; the GROIN; and the BACK.
Low Back Pain
Acute or chronic pain in the lumbar or sacral regions, which may be associated with musculo-ligamentous SPRAINS AND STRAINS; INTERVERTEBRAL DISK DISPLACEMENT; and other conditions.
Back Pain
Acute or chronic pain located in the posterior regions of the THORAX; LUMBOSACRAL REGION; or the adjacent regions.
Sacroiliitis
Inflammation of the SACROILIAC JOINT. It is characterized by lower back pain, especially upon walking, fever, UVEITIS; PSORIASIS; and decreased range of motion. Many factors are associated with and cause sacroiliitis including infection; injury to spine, lower back, and pelvis; DEGENERATIVE ARTHRITIS; and pregnancy.
Clinical Trials
Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain
To assess two regimens of thiocolchicoside injection and capsule in combination with either diclofenac or ibuprofen in patients with acute low back pain.
EMINEM: Efficacy of Muscoril In NEck Myofascial Syndromes
Study objective: - To demonstrate, in patients with myofascial pain syndrome in cervical region, the degree of efficacy of thiocolchicoside ointment administered to trigger point...
Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood
This is a Randomized double blind trial with the aim to estimate the effectiveness of 3 therapeutic regimes per os on migraine pain: - metoclopramide 0,15 mg/kg + placebo - m...
Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury
Imprimis Pharmaceuticals is investigating a proprietary, topical cream formulation consisting of 10% ketoprofen (containing 100 mg of ketoprofen in 1gram of cream) for the local treatment...
Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee
The purpose of the study is to evaluate the safety and effectiveness of the investigational ketoprofen patch with a controlled heating patch, compared to placebo (inactive substance) for t...
PubMed Articles
BACKGROUND: This study investigated the effects of thiocolchicoside to prevent cerebral vasospasm in a rabbit model of subarachnoid hemorrhage. METHODS: Twenty-four adult male New Zealand white rabbit...
The in vitro effects of the injectable form of analgesic drugs, dexketoprofen trometamol, dexamethasone sodium phosphate, metamizole sodium, diclofenac sodium, thiocolchicoside, on the activity of pur...
Forced degradation study of thiocolchicoside: characterization of its degradation products.
Thiocolchicoside (TCC, N-[1,2-dimethoxy-10-methylsulphanyl-9-oxo-3-(3,4,5-trihydroxy-6-hydroxymethyl-tetrahydropyran-2-yloxy)-5,6,7,9-tetrahydro-benzo[a]heptalen-7-yl]-acetamide) was subjected to hydr...
Metastatic bone disease is a serious clinical complication for the treatment of patients with advanced cancer, yet few therapeutic options are currently available. Bisphosphonates are an established s...
Preparation and characterization of ketoprofen-loaded microspheres for embolization.
To deliver drug locally and relieve the syndrome of pain after uterine artery embolization, N-[tris (hydroxymethyl) methyl] acrylamide-gelatin microspheres were prepared based on inverse suspension po...
