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NCT00634010 · ClinicalTrials.gov registry record · Phase 3
Morphine Versus Methadone As First Line Strong Opioid for Cancer Pain
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 36
- Enrollment target
NCT00634010: Clinical Trial Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT00634010 is a Phase 3 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 36 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00634010, a Phase 3 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 36 participants
- Enrollment target
Study Summary
Primary Aims: * To determine whether methadone used as first line strong opioid is superior to morphine as evidenced by reduced pain over a 12-week treatment period in patients with advanced cancer. Previous studies have demonstrated consistent improvement of pain control after opioid rotation from morphine to methadone. In addition, the pilot study showed that there was a trend towards lower pain intensity when methadone used as first line opioid as compared to morphine. Researchers postulate that due to its superior analgesic effects, methadone will result in better pain control over time as compared to morphine. * To determine whether methadone used as first line strong opioid is superior to morphine as evidenced by reduced frequency of neurotoxicity, dose escalation and treatment failure over a 12-week treatment period. Previous studies have demonstrated that patients develop increased pain or neurotoxicity after chronic use of morphine and require frequent opioid escalation. Researchers postulate that methadone will demonstrate lower opioid induced neurotoxicity, less frequent dose escalation and less treatment failure over 12-week treatment period as compared to morphine. Secondary Aim: -To perform an economic evaluation, comparing the costs and clinical benefits of methadone and morphine. Researchers will perform an evaluation that incorporates both treatment and potential "downstream" costs, as well as an examination of clinical benefits that incorporate preferences, to perform an appropriate economic comparison. We postulate that methadone and its associated costs will be cheaper than morphine. However, if one strategy is both more expensive and clinically superior than the other, researchers are prepared to perform an incremental cost-effectiveness analysis. In that case, researchers expect to show that the greater pharmaceutical costs involved with morphine will make its use not be a cost-effective strategy.
Interventions
- DRUG Methadone
- DRUG Morphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2008-02 |
| Est. Completion | 2015-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00634010
The ClinicalTrials.gov registry entry for NCT00634010 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Methadone is the first listed.
NCT00634010 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00634010 about?
NCT00634010 is a clinical study titled "Morphine Versus Methadone As First Line Strong Opioid for Cancer Pain". Primary Aims: * To determine whether methadone used as first line strong opioid is superior to morphine as evidenced by reduced pain over a 12-week treatment period in patients with advanced cancer. Previous studies have demonstrated consistent improvement of pain control after opioid rotation from...
What is the current status of trial NCT00634010?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 36 participants. The study started on 2008-02. Estimated completion is 2015-01.
What interventions are being tested in trial NCT00634010?
The interventions under investigation include: Methadone (DRUG), Morphine (DRUG).
Who is sponsoring clinical trial NCT00634010?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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