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Multiple-Ascending-Dose Study to Evaluate the Safety of Propoxyphene Napsylate In Healthy Adult Subjects

NCT01133873 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2011-04-13

No results posted yet for this study

Summary

The purpose of this study is to determine the daily maximum tolerated dose of propoxyphene napsylate in healthy subjects.

Conditions

  • Healthy

Interventions

DRUG

Propoxyphene napsylate (XP20C)

100 mg capsules 6 times a day in ascending doses until a maximum tolerated dose is identified

DRUG

Placebo

6 times a day in ascending doses until a maximum tolerated dose is identified

Sponsors & Collaborators

  • Xanodyne Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Lynn R Webster, MD · Lifetree Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01133873 on ClinicalTrials.gov