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NCT00558870 · ClinicalTrials.gov registry record · Phase 2
Role of Methadone As Co-Opioid Analgesic
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT00558870: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00558870 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00558870, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
Objectives: Primary Objective: To determine whether the addition of low dose methadone to morphine(in the methadone group) has a lower dose escalation index as compared to the morphine alone(in the morphine group) at Day 15 (+/- 3 days) Secondary Objectives: To determine whether individuals on the methadone arm have lower pain intensity than the morphine alone arm as demonstrated by a decrease in two points from baseline (+/- 3 days) in their ESAS score at Day 15 (+/- 3 days). To determine whether the methadone group of experiences fewer opioid induced neurotoxic side effects (including sedation, myoclonus, hallucinations, hyperalgesia and confusion) as compared to the morphine alone group at Day 15 (+/- 3 days).
Primary Outcome
Objective response (OR) is defined as a dose escalation index \<20 where Opioid escalation index measured in milligrams is calculated by the formula, (OMD-OSD)/days, OMD = Opioid maximum dose as expressed in equianalgesic dose of oral morphine in milligrams, OSD= Opioid starting dose at the time of referral to palliative care/ pain specialist for the treatment of cancer pain as expressed in equianalgesic dose of oral morphine in milligrams. A low index indicates the achievement of adequate analg
Interventions
- DRUG Methadone
- DRUG Morphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2007-11 |
| Est. Completion | 2015-01 |
| Phase | Phase 2 |
Why NCT00558870 stopped before completion
NCT00558870 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Methadone is the first listed.
NCT00558870 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00558870 about?
NCT00558870 is a clinical study titled "Role of Methadone As Co-Opioid Analgesic". Objectives: Primary Objective: To determine whether the addition of low dose methadone to morphine(in the methadone group) has a lower dose escalation index as compared to the morphine alone(in the morphine group) at Day 15 (+/- 3 days) Secondary Objectives: To determine whether individuals on t...
What is the current status of trial NCT00558870?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2007-11. Estimated completion is 2015-01.
What interventions are being tested in trial NCT00558870?
The interventions under investigation include: Methadone (DRUG), Morphine (DRUG).
Who is sponsoring clinical trial NCT00558870?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00558870's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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