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A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms

NCT00817986 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2021-02-21

No results posted yet for this study

Summary

The purpose of the study is to evaluate safety and tolerability of arbaclofen placarbil sustained release tablets taken every 12 hours compared to placebo in subjects with acute back spasms in the lumbar region.

Conditions

Interventions

DRUG

Arbaclofen placarbil, 20 mg

tablets

DRUG

Placebo

tablets

DRUG

Arbaclofen placarbil, 30 mg

tablets

DRUG

Arbaclofen placarbil, 40 mg

tablets

Sponsors & Collaborators

  • XenoPort, Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Indivior Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT00817986 on ClinicalTrials.gov