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Palliative Morphine With or Without Concurrent Modafinil

NCT01766323 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-01-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Dr. Rajendra Prasad Government Medical College

    lead OTHER

Principal Investigators

  • Swaroop Revannasiddaiah, MD · Dr. Rajendra Prasad Government Medical College; Bangalore Institute of Oncology

  • Muninder K Negi, MD · Dr. Rajendra Prasad Government Medical College; Indira Gandhi Medical College

  • Sridhar P Susheela, MD · Bangalore Institute of Oncology

  • Madhup Rastogi, MD · Ram Manohar Lohia Insitute of Medical Sciences

  • Manoj K Gupta, MD · Indira Gandhi Medical College, Shimla

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-06-30
Completion
2013-08-31

Countries

  • India

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01766323 on ClinicalTrials.gov