A clinical trial to study of Flupirtine Maleate Vs Tramadol Hydrochloride in patients with acute & subacute pain

Phase 3

Completed

• Conditions: Acute & subacute pain.

• Registration Number: CTRI/2009/091/000970
• Lead Sponsor: Lupin Ltd Mumbai

Brief Summary

It will be an open label, randomized trial involving minimum 200 PATIENTS WITH ACUTE AND SUBACUTE PAIN patients TO ASSESS THE SAFETY AND EFFICACY OF FUPIRTINE MALEATE VS TRAMADOL HYDROCHOLRIDE.DURATION OF TREATMENT WILL BE FIVE TO SEVEN DAYS PRIMARY OUTCOME OF THE TRIAL TO ASSESS AND COMPARE THEPain (Visual Analog Scale )Pain Relief Rate ,SECONDARY OUTCOME IS TO ASSESS THE ADVERSE EVENT AND CONSUMPTION OF RESCUE MEDICATION FOR 7 DAYS

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-01
• Last Update Posted: 2013-12-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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

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:?Pain assessment (VAS )1?Pain Relief Rate2Based 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	5-7 DAYS

Secondary Outcome Measures

Name	Time	Method
Safety will be assessed based on analysis in the following variables:	?Adverse events

Trial Locations

Locations (7)

Mhate Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Moralwar Day Care Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Sawla nursing home; 🇮🇳 Mumbai, MAHARASHTRA, India

Spandan Hospital & special Rheumatology Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Surgicare Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Vinod Hospital; 🇮🇳 Jalgaon, MAHARASHTRA, India

Yash Speciality Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Mhate Clinic

🇮🇳Mumbai, MAHARASHTRA, India

Dr.Aziz Mhate

Principal investigator

09820645023

draziz_mhate@yahoo.com