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Intravenous Tapentadol in Post-Bunionectomy Pain

NCT01435577 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2019-10-28

Study results available
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Summary

The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.

Conditions

Interventions

DRUG

Tapentadol

30 mg per administration, maximum 12 administrations over 48 hours

DRUG

Matching Placebo

Maximum 12 administrations over 48 hours

Sponsors & Collaborators

  • Grünenthal GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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 NCT01435577 on ClinicalTrials.gov