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Pharmacodynamic Differences Between Branded and Unbranded Remifentanil Molecules

NCT02048293 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2014-01-29

No results posted yet for this study

Summary

Unbranded drug molecules are produced after the patent of a given drug has expired. Unbranded molecules of Remifentanil have been marketed in Colombia, and several reports by anesthesiologist indicate that there are differences in the physiologic response of patients to these molecules. The investigators hypothesized that unbranded molecules of remifentanil require higher doses to obtain desired physiological responses as compared to the branded molecule.

Conditions

Interventions

DRUG

Remifentanyl, Ultiva®

Anesthetic induction for orotracheal intubation. Group O

DRUG

Remifentanil Laboratorios Chalver de Colombia S.A.

Anesthetic induction for orotracheal intubation. Group A

DRUG

Fada Remifentanilo

Anesthetic induction for orotracheal intubation. Group B

Sponsors & Collaborators

  • Hospital de San Jose

    collaborator OTHER

  • Fundación Universitaria de Ciencias de la Salud

    lead OTHER

Principal Investigators

  • luis e reyes, professor · fundacion universitaria de ciencias de la salud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-10-31
Completion
2013-12-31

Countries

  • Colombia

More Related Trials

Entities

Diseases

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 NCT02048293 on ClinicalTrials.gov