Palliative Morphine With or Without Concurrent Modafinil

NCT ID: NCT01766323

Last Updated: 2013-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-08-31

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.

Conditions

Cancer; Pain Palliation; Excessive Sleepiness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Arm Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Arm-Modafinil

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

Group Type: ACTIVE_COMPARATOR

Modafinil

Intervention Type: DRUG

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

Interventions

Modafinil

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Rajendra Prasad Government Medical College

OTHER

Sponsor Role: lead

Responsible Party

Swaroop Revannasiddaiah

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Swaroop Revannasiddaiah, MD

Role: PRINCIPAL_INVESTIGATOR

Dr. Rajendra Prasad Government Medical College; Bangalore Institute of Oncology

Muninder K Negi, MD

Role: STUDY_DIRECTOR

Dr. Rajendra Prasad Government Medical College; Indira Gandhi Medical College

Sridhar P Susheela, MD

Role: STUDY_CHAIR

Bangalore Institute of Oncology

Madhup Rastogi, MD

Role: STUDY_CHAIR

Ram Manohar Lohia Insitute of Medical Sciences

Manoj K Gupta, MD

Role: STUDY_CHAIR

Indira Gandhi Medical College, Shimla

Locations

Tanda Government Medical College and Hospital

Kangra, Himachal Pradesh, India

Site Status: RECRUITING

Countries

India

Central Contacts

Swaroop Revannasiddaiah, MD

Role: CONTACT

swarooptheone@gmail.com

918971862565

Muninder K Negi, MD

Role: CONTACT

lippa@rediffmail.com

919805192039

Facility Contacts

M N Kumar, MD

Role: primary

9805192039

Other Identifiers

ModMorphine

Identifier Type: -

Identifier Source: org_study_id