Last reviewed · How we verify

NCT03720717

Baclofen as a Perioperative Analgesic Adjuvant

Terminated Phase 4 Results posted Last updated 5 September 2024
What this trial tests

Phase 4 trial testing Baclofen 10mg in Pain in 34 participants. Terminated before completion.

Timeline
27 October 2020
Primary endpoint
28 October 2022
28 October 2022

Quick facts

Lead sponsorUniversity of Alabama at Birmingham
PhasePhase 4
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment34
Start date27 October 2020
Primary completion28 October 2022
Estimated completion28 October 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Alabama at Birmingham

Who can join

19 and older, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Postoperative Opioid Requirements Primary · From 0 hours post-operatively to 24 hours post-operatively

Patients Patients' opioid requirements for acceptable pain control will be assessed based on the total oral morphine equivalent needed for post operative pain control.

GroupValue95% CI
Opioid Tolerant - Baclofen85.5± 33.6
Opioid Tolerant - Placebo96.8± 17.1
Opioid Naive - Baclofen69.9± 10.0
Opioid Naive - Placebo40.4± 11.7

Sponsor's own description

The purpose of this study is to determine whether a single, oral dose of baclofen alters postoperative opioid requirements.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Use of Baclofen Premedication as an Analgesic Adjuvant in Patients Undergoing Percutaneous Nephrolithotripsy: A Placebo-Controlled, Double-Blind Randomized Trial.
    Mandabach M, Deichmann P, Massoll A, Graves S, et al · · 2024 · PMID 39130904 · DOI 10.7759/cureus.64235

Verify or expand the search:

Other trials of Baclofen 10mg

Trials testing the same drug.

Other recruiting trials for Pain

Currently open trials in the same condition.

Other University of Alabama at Birmingham trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03720717.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing