NCT02311777 is a Phase 3 clinical trial of Pregabalin in Phantom Pain, sponsored by University of Texas Southwestern Medical Center.

Who is sponsoring NCT02311777?

NCT02311777 is sponsored by University of Texas Southwestern Medical Center.

What drugs are being tested in NCT02311777?

Interventions in NCT02311777: Pregabalin, Ketamine, Placebo.

What condition does NCT02311777 study?

NCT02311777 studies Phantom Pain.

Is NCT02311777 still recruiting?

NCT02311777 is currently withdrawn. Last updated 19 December 2018.

Last reviewed 2018-12-19 · How we verify

NCT02311777

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pre-operative Pregabalin and Ketamine to Prevent Phantom Pain

Withdrawn Phase 3 Last updated 19 December 2018

What this trial tests

Phase 3 trial testing Pregabalin in Phantom Pain. Withdrawn.

Timeline

15 May 2015

Primary endpoint
20 September 2016

20 September 2017

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	prevention
Start date	15 May 2015
Primary completion	20 September 2016
Estimated completion	20 September 2017
Sites	2 locations across United States

Drugs / interventions tested

Pregabalin (Pregabalin) — full drug profile →
Ketamine (ketamine) — full drug profile →
Placebo

Conditions studied

Phantom Pain — all drugs for Phantom Pain →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 18 to 65, any sex, with Phantom Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Phantom limb pain (PLP) is as painful sensations located to the missing limb and classified as neuropathic pain. In the United States, an estimated 1.7 million patients have undergone limb amputation, and 60% to 80% of these patients develop PLP (1-2) and it is usually resistant to a wide variety of treatments (1-4). Three factors may contribute to the development of persistent, post-amputation PLP by inducing central sensitization at different times relative to surgery: pre-amputation pain, noxious intraoperative stimuli, and acute postoperative pain (5-7). Investigators hypothesis that pre-amputation period could be important in eliminating Phantom Limb Pain (PLP) in the patients in whom cortical reorganization is not yet established. The reduction of pre-operative pain and prevention of formation of pain memories may eliminate development of PLP by using dual networks treatment strategy. This Phase III, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy of pre-operative pregabalin (lyrica) and ketamine in eliminating phantom limb pain in patients undergoing lower limb amputation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Pregabalin

Trials testing the same drug.

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NCT07196657 — The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia · NA · recruiting

Other recruiting trials for Phantom Pain

Currently open trials in the same condition.

NCT05915065 — VR to Evaluate Phantom Limb Pain · NA · active not recruiting

Other University of Texas Southwestern Medical Center trials

Trials by the same sponsor.

NCT03849963 — Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain · recruiting
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NCT05145309 — Value of Potassium Magnesium Citrate in Preventing and Treating Hypertension in African Americans · Phase 2 · not yet recruiting
NCT06552000 — Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer · NA · not yet recruiting
NCT07387666 — Imaging Acetadote Metabolism in Glioblastoma · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02311777 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
Last refreshed: 19 December 2018

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/NCT02311777.

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