Health Condition 1: M792- Neuralgia and neuritis, unspecified
Conditions
Interventions
Intervention1: Fixed Dose Combination (FDC) of gabapentin 400 mg and nortriptyline 10 mg of Intas Pharmaceuticals Limited, India: Dose: One Tablet along with One Dummy Capsule
Frequency: Day 1-3 (Once Daily, Day 4-6(Twice Daily),
Day 7-35(Thrice a Day)
Mode of Administration:Oral
Duration of treatment: 35 days
Control Intervention1: Gabapentin 400 mg Capsule of Intas Pharmaceuticals Limited, India: Dose: One capsule along with Dummy Tablet
Frequency: Day 1-3 (Once Daily, Day 4-6(Twice Daily), Day 7-35(Thrice a Day)
Duration of treatment: 35 days
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients of either gender between 18 and 65 years (both inclusive). 2 Diagnosis of chronic neuropathic pain by investigator before at least 3 months of screening 3 Patient having daily pain score greater than or equal to 4 on Numeric Rating Scale (NRS) of 0-10 at the time of screening and on day of enrolment (after washout period). 4 Score of 12 or more on Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score 5 Patients have at least two of the following non-specific symptoms: allodynia (pain from a non-noxious stimulus, e.g. touch), burning pain, shooting pain, or hyperalgesia (increased sensitivity to a noxious stimulus) at the time of screening. 6 Provides written informed consent in accordance with applicable regulatory requirements
Exclusion criteria
Exclusion criteria: 1 Any major organ system disease, cardiovascular autonomic neuropathy, sedation or ataxia due to concomitant drugs or other cause. 2 Urinary symptoms attributable to benign prostatic hypertrophy in male participants. 3 Vitamin B12 level below 180 ng/L or uncontrolled hypothyroidism in spite of adequate treatment 4 Patients with any orthopaedic alteration of any extremity 5 Patients with peripheral artery disease 6 Patients taking more than two neuropathic pain medicines 7 Presence of a seizure disorder. 8 Patients who are receiving treatment with anti-depressants, antiepileptics 9 Patients with uncontrolled Angle-closure glaucoma. 10 Haemoglobin A1c concentration more than 13% at screening 11 Ongoing administration of Monoamine Oxidase (MAO) inhibitors and/or a serious psychiatric disorder as diagnosed by a psychiatrist. 12 A coexisting disorder causing pain as severe as the neuropathic pain. 13 Women of childbearing potential not receiving an effective form of contraception. 14 Pregnant woman or lactating mother. 15 Known hypersensitivity to gabapentin, nortriptyline or any of its ingredients. 16 Ongoing administration of anticonvulsants which induce cytochrome P450 enzymes (e.g., carbamazepine, oxcarbazepine). 17 Patient who require treatment with a drug that prolongs QT interval. 18 Creatinine clearance 19 Clinically significant laboratory abnormalities at the time of screening. 20 Abuse or dependency of alcohol, narcotics, opioids or any other addictive substances (other than Benzodiazepine). 21 Patients participated in any type of clinical study within the last 30 days of the screening date. 22 Unsuitability for enrollment otherwise as decided by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean pain intensity from baseline to end of treatment by Numeric Rating scale (NRS)Timepoint: From Baseline to end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change From Baseline to end of treatment in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score 2. Change in Global Impression of Patient Change (GIPC) Scale from baseline to end of treatment 3. Change in Clinical Global Impression of Change (CGIC) Scale from baseline to end of treatment 4. Safety evaluation by comparison of adverse events and serious adverse events in each arm.Timepoint: From Baseline to end of treatment | — |
Countries
India
Contacts
Public ContactMr Prashant Modi
Lambda Therapeutic Research Ltd
Outcome results
None listed