A study to see the effects of Gabapentin and amitriptyline as adjuvant with other pain killer in patients with cancer pai
- Conditions
- Health Condition 1: null- Neuropathic cancer pain
- Registration Number
- CTRI/2011/12/002182
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method