A clinical trial to study the effects of two drugs, D-9998 and CG-315 in patients with acute pain after orthopedic operation or injuries.
- Registration Number
- CTRI/2009/091/001056
- Lead Sponsor
- Sun Pharmaceutical Industries Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1.Male or female patients aged between 18 - 65 years.
2.Patient suffering from pain after orthopedic operation or due to injury.
3.Patient or his/her care taker willing to give their informed consent.
1.Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
2.Patients having hypersensitivity to the drug or other opioid analgesics.
3.Patients having risk of a hepatic encephalopathy.
4.Patient with cholestasis.
5.Patients with epilepsy, with a history of seizure, or patients with a recognized risk for seizure.
6.Patient with myasthenia gravis.
7.Patient addicted to alcohol.
8.Patient with liver disease.
9.Patients receiving SSRIs, TCAs or other tricyclic compounds, MAOIs, or neuroleptics.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the severity of pain on the VAS.Timepoint: Day 0, Day 7
- Secondary Outcome Measures
Name Time Method Clinical global impression on improvementTimepoint: Day 7