Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Role of Methadone As Co-Opioid Analgesic

This study has been terminated.
(Low Accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00558870
First received: November 14, 2007
Last updated: March 7, 2016
Last verified: March 2016
Results First Received: February 1, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pain
Interventions: Drug: Morphine
Drug: Methadone

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: November 13, 2007 to August 26, 2010. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study was halted early due to slow accrual. One participant of the five enrolled did not get randomized therefore did not receive treatment and is excluded.

Reporting Groups
  Description
Morphine Only 2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
Morphine + Methadone 1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.

Participant Flow:   Overall Study
    Morphine Only   Morphine + Methadone
STARTED   2   2 
COMPLETED   2   2 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Morphine Only 2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
Morphine + Methadone 1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
Total Total of all reporting groups

Baseline Measures
   Morphine Only   Morphine + Methadone   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   2   4 
Age 
[Units: Years]
Median (Full Range)
 45 
 (42 to 48) 
 35 
 (28 to 42) 
 42 
 (28 to 48) 
Gender 
[Units: Participants]
     
Female   2   2   4 
Male   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   1   1 
White   2   1   3 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   2   2   4 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Objective Response (OR)   [ Time Frame: Day 15 (+/- 3 days) ]

2.  Primary:   Dose Escalation Index at Day 15 (+/- 3 Days)   [ Time Frame: Day 15 (+/- 3 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study sample size is too low for any of the differences or non-differences between the groups to be statistically significant.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sriram Yennurajalingam, Palliative Care & Rehabilitation Medicine
Organization: University of Texas (UT) MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00558870     History of Changes
Other Study ID Numbers: 2006-0641
NCI-2012-01553 ( Registry Identifier: NCI CTRP )
Study First Received: November 14, 2007
Results First Received: February 1, 2016
Last Updated: March 7, 2016
Health Authority: United States: Institutional Review Board