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.

Evaluation of efficacy and safety of D-9998 versus CG-315 in the treatment of acute pain after orthopedic operation or injuries: a randomized, open-label, active-controlled, multi-centre study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/001056

Enrollment

200

Registered

2010-01-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: D-9998: Three times daily Control Intervention1: CG-315: Three times daily

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Change in the severity of pain on the VAS.Timepoint: Day 0, Day 7	—

Secondary

Measure	Time frame
Clinical global impression on improvementTimepoint: Day 7	—

Countries

India

Contacts

Public ContactDr. Surendra Borgharkar

medical.services@sunpharma.com02266969696

Outcome results