CTRI/2022/09/045408CompletedPhase 4
An Open Label, Randomized, 3 Arm, Multicentric, Prospective Clinical Study to assess theEfficacy, Safety and Tolerability of Fixed Dose Combination of Gabapentin 400mg andNortriptyline HCl 10mg Vs Gabapentin 400mg Vs Nortriptyline HCl 10mg in Adultpatients with Peripheral Neuropathy with or without association of Diabetes Mellitus.
Sunglow Life Science Pvt Ltd0 sitesEnrollment: 0Started: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Pms
Eligibility Criteria
Inclusion Criteria
- Men and women of at least 18 years of age willing to give informed consent for the study.
- Patients diagnosed with peripheral neuropathy who have abnormalities in 2 of 3 categories (signs, symptoms, and objective tests of nerve conduction studies or quantitative sensory threshold testing).
- Patients with peripheral neuropathy associated with diabetes that is stable and controlled (HbA1C = than 10 %) with no new symptoms associated with diabetes within previous 3 months.
- Patients with at least mild painful symptoms of diabetic neuropathy for at least 1 year duration, but not longer than 10 years duration
- Patients on pain medication (prescribed analgesics), stable for atleast 3 months before study entry or pain treatment naive.
- Patients having Toronto Clinical Neuropathy Score (TCNS) = 6 at screening/ baseline visit(Day 1/ Week 0)
Exclusion Criteria
- Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control.
- Escalating or changing pain condition within the past month as evidenced by investigator examination.
- Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days.
- Subject has had radiofrequency treatment of an intended target dorsal root ganglion within the past 3 months.
- Subject currently has an active implantable device including implanted cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump.
- Subjects currently has an active infection.
- Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates participation in this clinical trial.
- Subject has participated in another clinical investigation within 30 days that may confound the outcomes of the current study as determined by the investigator.
Investigators
Identifiers
- CTRI ID
- CTRI/2022/09/045408
- Other Study IDs
- CT-CE-01-2016 Version 03 04/Oct/2021
Dates
- Last updated
- (2 years ago)
Regulatory & Sharing
- Has Results
- No
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