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Phase 1 Thorough QT Study in Young Healthy Volunteers

NCT00485667 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-02-16

No results posted yet for this study

Summary

A reduction in the postoperative need for opioids to enhance the recovery process and increase patient postoperative satisfaction.

Conditions

  • Postoperative Pain

Interventions

DRUG

SKY0402

Subects received either 300mg or 450mg

DRUG

Moxifloxacin 400mg

DRUG

Placebo injection

DRUG

Placebo tablet

Sponsors & Collaborators

  • Richmond Pharmacology Limited

    collaborator INDUSTRY

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Jorg Taubel, MD MFPM · Richmond Pharmacology Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United Kingdom

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 NCT00485667 on ClinicalTrials.gov