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Prospective Randomized Study Evaluating the Effects of Modafinil in Patients Receiving Oral Morphine for Pain Palliation
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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Tanda Government Medical College and Hospital
Kangra, Himachal Pradesh, India
Start Date
September 1, 2012
Primary Completion Date
June 1, 2013
Completion Date
August 1, 2013
Last Updated
January 11, 2013
200
ESTIMATED participants
Modafinil
DRUG
Placebo
DRUG
Lead Sponsor
Dr. Rajendra Prasad Government Medical College
NCT06898450
NCT06316895
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06696768