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Palliative Morphine With or Without Concurrent Modafinil

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ClinicalTrials.gov Identifier: NCT01766323
Recruitment Status : Unknown
Verified January 2013 by Swaroop Revannasiddaiah, Dr. Rajendra Prasad Government Medical College.
Recruitment status was:  Recruiting
First Posted : January 11, 2013
Last Update Posted : January 11, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Pain Palliation Excessive Sleepiness Drug: Modafinil Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Prospective Randomized Study Evaluating the Effects of Modafinil in Patients Receiving Oral Morphine for Pain Palliation
Study Start Date : September 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Arm Placebo
Oral placebo 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
Active Comparator: Arm-Modafinil
Oral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation
Drug: Modafinil
Oral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation


Outcome Measures

Primary Outcome Measures :
  1. Patient reported sleepiness scores [ Time Frame: Three months from enrollment ]
    Patient reported sleepiness scores will be recorded as per a visual analogue scale with scores ranging from 1 (no unusual sleepiness) to 5 (unable to stay awake). Recordings will be done on the first day of intervention, and repeated recordings will be procured once every two weeks till a total of seven readings are obtained over a time span of 3 months.


Secondary Outcome Measures :
  1. Mood changes [ Time Frame: Three months from enrollment ]
    Patients will be requested to report their self-perceived mood status by choosing one of three discrete options (improvement, worsening, no change). Each patient will provide a total of three responses over a period of three months from enrollment (at the end of each month from enrollment).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766323


Contacts
Contact: Swaroop Revannasiddaiah, MD 918971862565 swarooptheone@gmail.com
Contact: Muninder K Negi, MD 919805192039 lippa@rediffmail.com

Locations
India
Tanda Government Medical College and Hospital Recruiting
Kangra, Himachal Pradesh, India, 176001
Contact: M N Kumar, MD    9805192039      
Principal Investigator: Swaroop Revannasiddaiah, MD         
Sponsors and Collaborators
Dr. Rajendra Prasad Government Medical College
Investigators
Principal Investigator: Swaroop Revannasiddaiah, MD Dr. Rajendra Prasad Government Medical College; Bangalore Institute of Oncology
Study Director: Muninder K Negi, MD Dr. Rajendra Prasad Government Medical College; Indira Gandhi Medical College
Study Chair: Sridhar P Susheela, MD Bangalore Institute of Oncology
Study Chair: Madhup Rastogi, MD Ram Manohar Lohia Insitute of Medical Sciences
Study Chair: Manoj K Gupta, MD Indira Gandhi Medical College
More Information

Responsible Party: Swaroop Revannasiddaiah, Principal Investigator, Dr. Rajendra Prasad Government Medical College
ClinicalTrials.gov Identifier: NCT01766323     History of Changes
Other Study ID Numbers: ModMorphine
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: January 11, 2013
Last Verified: January 2013

Keywords provided by Swaroop Revannasiddaiah, Dr. Rajendra Prasad Government Medical College:
Morphine
Palliation
Cancer
Hospice
Sleepiness
Modafinil

Additional relevant MeSH terms:
Morphine
Modafinil
Armodafinil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action