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A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Elective Unilateral Total Knee Replacement

NCT00612534 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2014-02-17

Study results available
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Summary

The purpose of this study is to evaluate three different dosage strengths of sublingual ARX-F01 (Sufentanil NanoTab) versus a sublingual Placebo NanoTab for the treatment of post-operative pain in subjects following total knee replacement surgery. We hypothesize that subjects receiving placebo will have poor pain relief and will drop out of the study sooner and more often than the ARX-F01-treated subjects.

Conditions

  • Post Operative Pain

Interventions

DRUG

Sufentanil NanoTab

5 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours

DRUG

Placebo NanoTab

Placebo NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours

DRUG

Sufentanil NanoTab

10 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours

DRUG

Sufentanil NanoTab

15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours

Sponsors & Collaborators

  • Talphera, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

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 NCT00612534 on ClinicalTrials.gov