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Efficacy and Safety of Pregabalin/Tramadol Combination Versus Pregabalin in Acute Pain of Neuropathic Origin

NCT05324059 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-06-15

No results posted yet for this study

Summary

Phase IIIb confirmatory study of efficacy and safety, longitudinal, multicenter, randomized, double-blind study of the combination Pregabalin/Tramadol versus Pregabalin in the management of acute pain of neuropathic origin.

Conditions

  • Neuropathic Pain

Interventions

DRUG

Pregabalin 75mg/ Tramadol 50 mg

Pharmaceutical Form: Tablet Dosage: 75 mg / 50 mg Administration way: oral

DRUG

Pregabalin 75mg

Pharmaceutical Form: Capsule Dosage: 75 mg Administration way: oral

Sponsors & Collaborators

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Rodrigo Suárez Otero, M.D · Independent consultant

  • Isabel E Rucker, M.D · Clinical Research Institute

  • Luis R Partida, M.D · Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.

  • Alfonso Hernández Zepeda, M.D · IMACEN S.A. de C.V.

  • Ma. Dolores Alonso Martínez, M.D · CICMEX, Centro de Investigación Clínica de México S. de R.L de C.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-11
Primary Completion
2023-04-18
Completion
2023-04-25

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05324059 on ClinicalTrials.gov