Trial | NCT01766323  Report issue

Title

Palliative Morphine With or Without Concurrent Modafinil
Prospective Randomized Study Evaluating the Effects of Modafinil in Patients Receiving Oral Morphine for Pain Palliation

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    modafinil ...

  • Study Participants

    200
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.
Study Started
Sep 30
2012
Primary Completion
Jun 30
2013
Anticipated
Study Completion
Aug 31
2013
Anticipated
Last Update
Jan 11
2013
Estimate

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

Arm Placebo Placebo Comparator

Oral placebo b.i.d, along with the dose of oral morphine required for pain palliation

Arm-Modafinil Active Comparator

Oral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation

Criteria 

Inclusion Criteria:

Diagnosed and confirmed malignancy
Able to orally consume tablets
Blood Pressure: Systolic <144mmHg; Diastolic <92mmHg
Normal blood sugar
No active systemic infections
Consenting
Oral morphine being consumed as a part of terminal symptom palliation

Exclusion Criteria:

Candidates receiving oral morphine for temporary pain management, such as being potential candidates for radical curative approaches in the future
Poor performance status (Karnofsky Performance Status score <50)
Prior history of hypertension, diabetes, tuberculosis, epilepsy
Prior history of psychiatric and neurological illness
No Results Posted