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NCT00246532 · ClinicalTrials.gov registry record · Phase 4
Opiate-Induced Tolerance & Hyperalgesia in Pain Patients
A Phase 4 study, sponsored by National Institute of General Medical Sciences (NIGMS).
- Completed
- Registry status
- Phase 4
- Development phase
- 139
- Enrollment target
NCT00246532: Completed Phase 4 study, sponsored by National Institute of General Medical Sciences (NIGMS).
NCT00246532 is a Phase 4 study that has completed, run by National Institute of General Medical Sciences (NIGMS). The registered enrollment target is 139 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00246532, a Phase 4 study, has completed, sponsored by National Institute of General Medical Sciences (NIGMS).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 139 participants
- Enrollment target
Study Summary
Opiates such as morphine are the cornerstone medications for the treatment of moderate to severe pain. Recent evidence suggests that pain patients on chronic opioid therapy become more sensitive to pain (hyperalgesia) over time. There is also a long-standing notion that analgesic tolerance to opioids (habituation) develops during chronic use even though this phenomenon has never been prospectively studied. Our specific aims propose to prospectively test the hypotheses that; 1) Pain patients on chronic opioid therapy develop dose-dependent tolerance and/or hyperalgesia to these medications over time, 2) Opioid-induced tolerance and hyperalgesia develop differently with respect to various types of pain, 3) Opioid-induced hyperalgesia occurs independently of withdrawal phenomena, and 4) Opioid-induced tolerance and hyperalgesia develop differently based on gender and/or ethnicity. This proposed study will be the first quantitative and prospective study of tolerance and hyperalgesia in pain patients and will have important implications for the rational use of opioids in the treatment of chronic pain.
Interventions
- DRUG Placebo
- DRUG Morphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2005-10 |
| Est. Completion | 2009-08 |
| Phase | Phase 4 |
What the finished NCT00246532 record still lists
NCT00246532 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00246532 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00246532 about?
NCT00246532 is a clinical study titled "Opiate-Induced Tolerance & Hyperalgesia in Pain Patients". Opiates such as morphine are the cornerstone medications for the treatment of moderate to severe pain. Recent evidence suggests that pain patients on chronic opioid therapy become more sensitive to pain (hyperalgesia) over time. There is also a long-standing notion that analgesic tolerance to opioid...
What is the current status of trial NCT00246532?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 139 participants. The study started on 2005-10. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00246532?
The interventions under investigation include: Placebo (DRUG), Morphine (DRUG).
Who is sponsoring clinical trial NCT00246532?
This trial is sponsored by National Institute of General Medical Sciences (NIGMS), which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00246532's enrollment target sits among peer trials
139 593rd of 2000 higher than 1,408 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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