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NCT04160520 · ClinicalTrials.gov registry record · Phase 1
Pramipexole and Morphine for Renal Colic
A Phase 1 study, sponsored by East Carolina University.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT04160520 is a Phase 1 study that has completed, run by East Carolina University. The registered enrollment target is 19 participants.
The verdict
NCT04160520, a Phase 1 study, has completed, sponsored by East Carolina University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
Opioid analgesics are among the most commonly prescribed class of medications in the US. While opioids may effectively control pain and other sensory disorders under acute conditions, the rates of misuse/abuse and accidental overdose have reached epidemic proportions. Clinicians are being challenged to find alternatives to opioid analgesics, or to reduce their use in treating pain whenever possible. Pre-clinical studies have shown that combining morphine (opioid drug) with pramipexole (dopamine 3 receptor agonist with some D2/D4 action) provides superior analgesia against painful stimuli than morphine alone. This analgesia is maintained even when the dose of morphine is lowered to a dose that is not effective on its own. A recent case report describes the use of this combination to restore pain control in a patient with restless legs syndrome, for which opioids alone have lost their effectiveness (Happe S, Clemens S and Brewer KL, In Review). This application proposes to establish a new therapeutic approach for treatment of a pain associated with renal colic (a common painful condition) using a novel combination of 2 existing, FDA-approved drugs. The immediate goal is to demonstrate that this drug combination can provide similar analgesia to opioid alone, and that analgesia is maintained when the opioid dose is reduced by 50%.
Interventions
- DRUG Placebo oral tablet
- DRUG Morphine
- DRUG Pramipexole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-10-28 |
| Est. Completion | 2023-01-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04160520
The ClinicalTrials.gov registry entry for NCT04160520 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is East Carolina University, which has 58 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo oral tablet is the first listed.
NCT04160520 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04160520 about?
NCT04160520 is a clinical study titled "Pramipexole and Morphine for Renal Colic". Opioid analgesics are among the most commonly prescribed class of medications in the US. While opioids may effectively control pain and other sensory disorders under acute conditions, the rates of misuse/abuse and accidental overdose have reached epidemic proportions. Clinicians are being challenged...
What is the current status of trial NCT04160520?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2019-10-28. Estimated completion is 2023-01-24.
What interventions are being tested in trial NCT04160520?
The interventions under investigation include: Placebo oral tablet (DRUG), Morphine (DRUG), Pramipexole (DRUG).
Who is sponsoring clinical trial NCT04160520?
This trial is sponsored by East Carolina University, which has 58 total clinical trials registered on ClinicalTrials.gov.
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