drugset / Trial / NCT01766323

Palliative Morphine With or Without Concurrent Modafinil

NCT01766323

Phase 3 Unknown 200 enrolled Dr. Rajendra Prasad Government Medical College
RandomizedParallel-groupSingle-blindSupportive care

Summary

Oral morphine is often utilized as a convenient and effective method of achieving palliation of pain in the terminally ill cancer patients. However, at effective doses, a majority of patients do experience an undue amount of excessive sleepiness. Given the generally low expected survival periods among this patient population, the fact that morphine causes the patient to spend a significant period of remaining life in sleep, is often unacceptable for the patients and their families. Given the proven benefits of modafinil in conditions characterized by excessive sleepiness (such as with narcolepsy and shift-work disorder), the investigators designed a prospective placebo controlled randomized trial by the addition of modafinil at a dose of 200mg per day (in two divided doses) for eligible patients after randomization.

Timeline

Start
2012-09
Primary completion
2013-06
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Modafinil Small molecule 100 mg Oral

Indications