Status:
COMPLETED
A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms
Lead Sponsor:
XenoPort, Inc.
Conditions:
Back Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 lum...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT00817986
Start Date
December 1 2008
End Date
July 1 2009
Last Update
February 21 2021
Active Locations (20)
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1
Litchfield Park, Arizona, United States, 85340
2
Anaheim, California, United States, 92084
3
Anaheim, California, United States, 92801
4
San Diego, California, United States, 92128