Ã¢â?¬Å?Post-approvaL, concurrent, observational Study to assess clinical effectiveness and safety of Pregabalin/Duloxetine In moderate to severe Neuropathic pain syndrome - PREVALENCE

Torrent Pharmaceuticals Ltd0 sites0 target enrollmentStarted: TBDLast updated: October 17, 2022

Trial Snapshot

No summary available.

•Ã¢â?¬Â¢Male or female patients 18 to 59 years
•Ã¢â?¬Â¢Newly diagnosed cases of peripheral Neuropathic pain with NRS scale score more than or equla to 4
•Ã¢â?¬Â¢Known cases of peripheral Neuropathic pain with NRS scale score more than or equal to 4 receiving stable doses of Gabapentinoid based therapy for at least four weeks
•Ã¢â?¬Â¢Patients willing follow-up for 4 W at the same centre

•1.Hypersensitivity to individual ingredients
•2.Unstable or untreated cases of Mood disorders or T2DM (HbA1c more than 9 percent and symptomatic requiring insulin therapy
•3.CKD with eGFR less than 30 ml per min
•4.clinically significant electrocardiogram (ECG) abnormalities or QTc more than or equal to 450 msec,
•5.liver enzymes, ALT or AST more than 3X, ALP more than 2.5X or ULN (upper limit of normal) or total bilirubin more than 1.5X of ULN,
•6.serum sodium level less than 130 mmol per L,
•7.DKA and/or history of DKA that required hospitalization
•8.For women only currently pregnant (confirmed with positive pregnancy test) or breast-feeding
•9.Type 1 diabetes mellitus patients
•10.Sexually active woman of childbearing age not practicing accepted birth control method
•11.Any other medication for pain control during the observation period other than acetaminophen used as rescue medication

Sponsor

Torrent Pharmaceuticals Ltd