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

Back Pain Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of XP19986 in Subjects With Acute Back Spasms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817986
• Other study ID #: XP-B-083
• Status: Completed
• Phase: Phase 2
• Start date: December 2008
• Est. completion date: July 2009

Study information

• Verified date: February 2021
• Source: XenoPort, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Acute moderate to severe muscle spasms in the lumbar region, as indicated by a minimum Visual Analog Scale pain severity score of 4.0 cm, beginning either:

• within four days prior to screening for subjects who do not require a 24-hour washout

Or

• within three days for subjects who require a 24-hour washout

2. Willing to discontinue all analgesics (e.g. NSAIDS, COX-2 inhibitors, acetaminophen), aspirin >81 mg/day, short-acting muscle relaxants (i.e. carisoprodol, Soma®), and herbal remedies for pain at least 24 hours prior to first dose and to refrain from use during the study (cardio-protective doses of aspirin = 81 mg /day are allowed).

Exclusion Criteria:

1. Clinically significant abnormal neurological history or examination at screening (excluding back spasm), including lumbar radicular symptoms, spinal stenosis, foot drop, herniated nucleus pulposus, or other structural defects

2. Subjects with back spasm related to major trauma to the region

3. Subjects with muscle spasms due to a work-related injury or subjects involved in any injury-related litigation

4. Subjects using any of the following medications at screening:

• Opioids, both short- and long-acting including but not limited to: morphine, fentanyl patch, oxycodone, tramadol)

• benzodiazepines, such as valium and lorazepam

• cyclobenzaprine containing drugs (e.g., Flexeril, Amrix)

• carisoprodol (e.g., Soma®) within 24 hours of screening

Related Conditions & MeSH terms

• Back Pain

Intervention

Drug:
• Arbaclofen placarbil, 20 mg
tablets
• Placebo
tablets
• Arbaclofen placarbil, 30 mg
tablets
• Arbaclofen placarbil, 40 mg
tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
XenoPort, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events	Safety was assessed based on the incidence, intensity and relationship of treatment emergent AEs	14 Days
Secondary	Change in pain severity score using the VAS		4 Days