Health Condition 1: null- Acute & subacute pain.
Conditions
Interventions
Intervention1: Flupirtine Maleate: ? Flupirtine Maleate (100 mg) capsule will be administered orally thrice a day for 5- 7 days.
? The maximum dose that can be administered of Flupirtine Maleate will
Sponsors
Lupin Ltd Mumbai
Eligibility
Inclusion criteria
Inclusion criteria:  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
Exclusion criteria
Exclusion criteria: &#61656; Patients < 18 years and >65 years2 &#61656; Patients with hepatic encephalopathy. &#61656; Patients suffering from myasthenia gravis. &#61656; Patients with various liver disease &#61656; Pregnant & lactating women2 &#61656; Orthopedic conditions showing degenerative changes &#61656; Known hypersensitivity to the Flupirtine Maleate or Tramadol Hydrochloride &#61656; Patients with concurrent, previous, or possible alcohol dependence, drug dependence or narcotic addiction2 &#61656; Participation in any other clinical trial in past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy will be assessed by improvement in following parameters: ? Pain assessment (VAS )1 ? Pain Relief Rate2 Based on a categorical transformation of the relative degree of pain relief rate : &#61656; <25% = unrelieved &#61656; 25-49% = mere relief &#61656; 50-74% = moderate relief &#61656; 75-99%= significant relief &#61656; 100%= complete relief Timepoint: 5-7 DAYS | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be assessed based on analysis in the following variables: ? Adverse events ? Rescue medication Timepoint: 5-7 DAYS | — |
Countries
India
Contacts
Public ContactDr Alok Chaturvedi
Outcome results
None listed