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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: Completed Phase 1 study, sponsored by East Carolina University.
NCT04160520 is a Phase 1 study that has completed, run by East Carolina University. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
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%.
Primary Outcome
Pain scores used are the numerical rating scale (0 low to 10 high) or visual analogue scale (0 low to 100mm high).
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 |
What the finished NCT04160520 record still lists
NCT04160520 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo oral tablet is the first listed.
NCT04160520 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04160520's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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