Pramipexole and Morphine for Renal Colic

November 8, 2019 updated by: East Carolina University

Adjuvant Treatment With Pramipexole to Reduce the Dose of Opioids Necessary for Analgesia in Acute 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 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%.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a double-blinded randomized controlled trial to take place in the Vidant Medical Center (VMC) Emergency Department (ED). A convenience sample of 96 participants will be drawn from patients presenting to the ED presentation with pain associated with suspected renal colic who do not experience pain relief after initial treatment with nonsteroidal anti-inflammatories.

Written informed consent will be sought by a study team member after screening to ensure all inclusion criteria and no exclusion criteria are met. Once a patient has consented, they will be randomized into 1 of 2 study arms: Arm 1 (Control arm) = 0.1mg/kg of intravenous morphine + placebo pill, single dose Arm 2 (Study arm) = 0.05mg/kg intravenous morphine + 0.25mg pramipexole, single dose. Both arms include a maximum dose of 10mg/kg for the IV morphine. Pain scores will be obtained prior to administration of study drugs, and at 15-minute intervals (+/- 2 mins) after treatment for up to 2 hours, or discharge from the ED. Subjective response to each drug treatment will also be assessed every 15 minutes (+/- 2 mins) after treatment for up to 2 hours, or discharge from ED. Morphine will have a max dose of 10mg IV.

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Allison Mainhart, BSCLR
  • Phone Number: 252-744-5568
  • Email: farmer@ecu.edu

Study Locations

  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • Vidant Medical Center ED
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Szu-Aun Lim, BS
        • Principal Investigator:
          • Kori Brewer, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 19 - 65
  • ED presentation with pain associated with suspected renal colic
  • Patient reported failure to achieve pain relief with NSAID treatment in ED (additional pain treatment needed per treatment team)

Exclusion Criteria:

  • Age < 19 or ≥ 66
  • Allergy to any study medication
  • Known pregnancy or breastfeeding
  • Received opioid prior to enrollment
  • Received IV Lidocaine during current ED visit
  • Known chronic renal disease
  • Currently taking any dopamine receptor agonist or antagonists (Do I need to list?)
  • Unable to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pramipexole and half-standard dose of morphine
0.25 mg oral tablet of pramipexole in combination with 0.05mg/kg of IV morphine
Drug: Pramipexole
Establish proof of concept that low dose morphine in combination with pramipexole is non-inferior to standard dose morphine with respect to providing analgesia in patients presenting to the ED with pain associated with renal colic.
Drug: Morphine
Establish proof of concept that low dose morphine in combination with pramipexole is non-inferior to standard dose morphine with respect to providing analgesia in patients presenting to the ED with pain associated with renal colic.
Active Comparator: Standard dose of morphine and placebo
0.1mg/kg of IV morphine in combination with a placebo pill
Drug: Morphine
Establish proof of concept that low dose morphine in combination with pramipexole is non-inferior to standard dose morphine with respect to providing analgesia in patients presenting to the ED with pain associated with renal colic.
Drug: Placebo oral tablet
Establish proof of concept that low dose morphine in combination with pramipexole is non-inferior to standard dose morphine with respect to providing analgesia in patients presenting to the ED with pain associated with renal colic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who have an effective analgesic response (defined as at least a 50% improvement in pain scores) at 120 minutes post-randomization.
Time Frame: 120 minutes
Pain scores used are the numerical rating scale (0 low to 10 high) or visual analogue scale (0 low to 100mm high).
120 minutes
Total dose of opioid received at 120 minutes in patients reporting a reduction in pain scores from baseline.
Time Frame: 120 minutes
Dose of opioid measured in mg/kg
120 minutes
Proportion of patients who require rescue medications at 30 minutes post-randomization.
Time Frame: 30 minutes
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to reach effective pain reduction (defined as at least a 50% improvement in pain scores) within 120 minutes of treatment.
Time Frame: 120 minutes
Pain scores used are the numerical rating scale (0 low to 10 high) or visual analogue scale (0 low to 100mm high).
120 minutes
Subjective effects of the drugs measured by scores on the drug effects questionnaire.
Time Frame: 120 minutes
Drug effects questionnaire rates symptoms from 'not at all' at 0mm to 'extremely' at 100mm.
120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Carolina University

Investigators

  • Principal Investigator: Kori Brewer, PhD, East Carolina University
  • Study Director: Allison Mainhart, BSCLR, East Carolina University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2019

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 5, 2019

First Submitted That Met QC Criteria

November 8, 2019

First Posted (Actual)

November 13, 2019

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 8, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECarolinaUniversity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Colic

Clinical Trials on Pramipexole

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe