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

Completed · Phase 2 · Has a placebo group

Conditions studied: Back Pain

In brief

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.

Key facts

Study ID

NCT00817986

Run by

XenoPort, Inc.

People needed

161

Starts

2008-12-01

Expected to finish

2009-07-01

Last updated by the study team

2021-02-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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).

You may not qualify if…

• 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
• Subjects with back spasm related to major trauma to the region
• Subjects with muscle spasms due to a work-related injury or subjects involved in any injury-related litigation
• 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

Where it is running

• Study site — Raleigh, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Anderson, South Carolina, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Litchfield Park, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Anaheim, California, United States
• Study site — San Diego, California, United States
• Study site — Vista, California, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Overland Park, Kansas, United States
• Study site — Erlanger, Kentucky, United States
• Study site — Traverse City, Michigan, United States
• Study site — Brick, New Jersey, United States

Full record on ClinicalTrials.gov

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