Health Condition 1: G968- Other specified disorders of central nervous system Health Condition 2: G588- Other specified mononeuropathies
Conditions
Interventions
Intervention1: Gabapentin 100 mg +
Nortriptyline 10 mg: Gabapentin 200 mg + Nortriptyline 10
mg
Intervention2: Gabapentin 100 mg + Nortriptyline 10 mg: Gabapentin 200 mg + Nortriptyline 10 mg
Interv
Sponsors
Synokem Pharmaceuticals Limited
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Males and females in the age-range of 18 and 65 years Patients must be vaccinated against COVID-19 (both doses) or they should be RT-PCR negative (if not vaccinated) Female patients without childbearing potential (postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. OR Female patients with childbearing potential are eligible if they use a medically accepted contraceptive method. Patient is considered reliable and capable of adhering to medication intake Patient having daily pain score 4 on Numeric Rating Scale (NRS) of 0-10 at the time of screening and on day of enrolment (after washout period) Score of 12 on Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score. HbA1c concentration 13 at screening. Written informed consent from the patient, legally acceptable representative, or parent and able to follow study procedures.
Exclusion criteria
Exclusion criteria: Patients who are not able to or not willing to sign an IRB IEC approved consent form. Female patients who are pregnant or lactating or planning to become pregnant during the study period. Patients with known hypersensitivity to any components of study drugs or excipients or a drug with similar chemical structure. Patients with concurrent hepatic and renal impairment. Urinary symptoms attributable to benign prostatic hypertrophy in male participants. Uncontrolled hypothyroidism Ongoing treatment with any neuropathic pain medicines. Presence of a seizure disorder and patients who are receiving treatment with antidepressants, antiepileptics or anticonvulsants. Patients with uncontrolled Angle-closure glaucoma. Ongoing administration of Monoamine Oxidase (MAO) inhibitors and/or a serious psychiatric disorder as diagnosed by a psychiatrist. Patient who requires treatment with a drug that prolongs QT interval. Clinically significant laboratory abnormalities at the time of screening. Abuse or dependency of alcohol, narcotics, opioids or any other addictive substances. Patients who have participated in any type of clinical study within the last 30 days of the screening date.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of FDC of Gabapentin 100 mg Nortriptyline 10 mg film coated tablets and Gabapentin 200 mg + Nortriptyline 10 mg film coated tablets in patients with Neuropathic Pain. Timepoint: Day 5, Day 14, Day 35, Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| To Evaluate efficacy of FDC of Gabapentin 100 mg Nortriptyline 10 mg film coated tablets & Gabapentin 200 mg Nortriptyline 10 mg film coated tablets in patients Timepoint: Day 5, Day 14, Day 35, Day 56 | — |
Countries
India
Contacts
Public ContactDr Rohit Kulkarni
Silver Birch Multispeciality Hospital
Outcome results
None listed