Health Condition 1: null- Neuropathic cancer pain
Conditions
Interventions
Intervention1: Gabapentin 100 + Placebo of Amitriptyline: BD for 15 days orally
Intervention2: Gabapentin 100 mg + Amitriptyline 10mg: BD for 15 days orally
Intervention3: Gabapentin Placebo + Amitrip
Sponsors
Indian Council of Medical Research
Gautam Majumder
Partha Sarathi Sutradhar
Eligibility
Inclusion criteria
Inclusion criteria: a. Age 18 years to 80 years b. Cancer Patients with neuropathic pain not controlled with opioid analgesics. c. Worst pain intensity >= 5 on a NRS from 0 â?? 10, in the 24 hour period to study entry. d. Stable dose of regularly scheduled systemic opioid therapy (Morphine >= 60 mg / 24 hour without sufficient analgesia for at least 24 hour. e. Life expectancy >= 30 days. f. Karnofsky performance status (KPS) >= 40.
Exclusion criteria
Exclusion criteria: a. Serum creatinine 2 times the upper limit of normal. b. Serum liver enzyme 5 times the upper limit of normal. c. Serum sodium 130 m Eq. d. Unable to take medication orally. e. Pregnant and lactating subjects. f. Other organ dysfunction. g. Chemotherapy from 3 days before screening. h. Radiotherapy to the pain producing lesion from 15 days before screening. i. Patients unable to communicate fluency in Bengali Hindi or English. j. Patients with history of epilepsy or use of anti epileptic drugs or neuropathic analgesics other than opioids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a.Pain score (burning and shooting) by Numerical rating scale (NRS) 0 â?? 10 using Brief pain Inventory (BPI) at day 0, 8 and 15 day after intervention. b. Assessment of interference of activity by pain during past 24 hour at day 0, 8 and 15 day after intervention Timepoint: 8 and 15 day after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of patients that achieved at least a one third reduction in their pain score {33% pain intensity difference (PID)}Timepoint: 8 and 15 day after intervention;Amount of rescue opioid analgesics.Timepoint: 8 and 15 day after intervention;Assessment of quality of pain relief by using â??Pain relief scaleâ?? (PRS) and â??Patientâ??s global impression changeâ?? (PGIC).Timepoint: 8 and 15 day after intervention;Presence and absence of allodynia.Timepoint: 8 and 15 day after intervention;Previous 24 hour opioid rescue dose.Timepoint: 8 and 15 day after intervention ;Recording of average daily paroxysmal pain (shooting and Lancinating) episodes.Timepoint: 8 and 15 day after intervention;Recording of toxicity based on four point scale.Timepoint: 8 and 15 day after intervention | — |
Countries
India
Contacts
Public ContactDebasis Ray
Agartala Govt. Medical College
Outcome results
None listed