WHO ICTRP trial

A Clinical Study to evaluate Efficacy and Safety of Tapentadol Nasal Spray in…

CTRI/2019/03/018143 · Clinical Trials Registry India (CTRI) · Not Recruiting

Key facts

Trial ID CTRI/2019/03/018143
Public title A Clinical Study to evaluate Efficacy and Safety of Tapentadol Nasal Spray in Comparison to Tramadol in Patients with Post-Operative Pain
Scientific title A Multicentric, Randomized, Open Label Clinical Trial to Evaluate Efficacy and Safety of Tapentadol Nasal Spray in Comparison to Tramadol Immediate Release Capsule and Intravenous Injection in Patients with Post-Operative Moderate to Severe Pain
Primary sponsor Torrent Pharmaceutical Ltd
Registry Clinical Trials Registry India (CTRI)
Recruitment status Not Recruiting
Study type Interventional
Phase Phase 3
Countries India
Conditions Health Condition 1: O- Medical and Surgical
Interventions Intervention1: Tapentadol: Nasal Spray 22.5 mg/45 mg every 4-6 hours for 05 days Control Intervention1: Tramadol: Injection 50mg/100mg every 4-6 hours for 1 day or 2 day Capsule 50mg/100mg every 4-6 hours for remaining 03/04 days
Registration date Mar 18, 2019
Target size 294
Secondary IDs CT/TAPE/PAIN/17/03 Version 2.1 21/12/2018
Registry page ctri.nic.in

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