A clinical trial to study of Flupirtine Maleate Vs Tramadol Hydrochloride in patients with acute & subacute pai
- Conditions
- Health Condition 1: null- Acute & subacute pain.
- Registration Number
- CTRI/2009/091/000970
- Lead Sponsor
- upin Ltd Mumbai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Age 18-65 years2
Both genders2
Patient willing to follow up and willing to comply with procedures and requirements
Patient with signs & symptoms of acute, subacute pain, pain due to musculoskeletal condition, low back pain3, post operative pain, acute orthopedic conditions like bone fracture2
Patients who have received other medication for pain but having no improvement
Patients < 18 years and >65 years2
Patients with hepatic encephalopathy.
Patients suffering from myasthenia gravis.
Patients with various liver disease
Pregnant & lactating women2
Orthopedic conditions showing degenerative changes
Known hypersensitivity to the Flupirtine Maleate or Tramadol Hydrochloride
Patients with concurrent, previous, or possible alcohol dependence, drug dependence or narcotic addiction2
Participation in any other clinical trial in past 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy will be assessed by improvement in following parameters:<br>?Pain assessment (VAS )1<br>?Pain Relief Rate2<br>Based on a categorical transformation of the relative degree of pain relief rate :<br>&#61656;<25% = unrelieved<br>&#61656;25-49% = mere relief <br>&#61656;50-74% = moderate relief <br>&#61656;75-99%= significant relief<br>&#61656;100%= complete relief<br>Timepoint: 5-7 DAYS
- Secondary Outcome Measures
Name Time Method Safety will be assessed based on analysis in the following variables: <br/ ><br>?Adverse events <br/ ><br>?Rescue medication <br/ ><br>Timepoint: 5-7 DAYS