NCT01766323

Palliative Morphine With or Without Concurrent Modafinil

Prospective Randomized Study Evaluating the Effects of Modafinil in Patients Receiving Oral Morphine for Pain Palliation

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Dr. Rajendra Prasad Government Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Pain Palliation
• Excessive Sleepiness

Interventions

Type	Name	Description
DRUG	Modafinil	Oral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation
DRUG	Placebo	Oral placebo b.i.d, along with the dose of oral morphine required for pain palliation

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-06-01
• Completion: 2013-08-01
• First posted: 2013-01-11
• Last updated: 2013-01-11

Locations

1 site across 1 country: India