A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms
NCT ID: NCT00817986
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
161 participants
INTERVENTIONAL
2008-12-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arbaclofen placarbil 20 mg
Arbaclofen placarbil 20 mg, BID, for 14 days including the taper period.
Arbaclofen placarbil, 20 mg
tablets
Placebo for Arbaclofen placarbil
Placebo for 14 days
Placebo
tablets
Arbaclofen placarbil 30 mg
Arbaclofen placarbil 30 mg, BID, for 14 days including the taper period.
Arbaclofen placarbil, 30 mg
tablets
Arbaclofen placarbil 40 mg
Arbaclofen placarbil 40 mg, BID, for 14 days including the taper period.
Arbaclofen placarbil, 40 mg
tablets
Interventions
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Arbaclofen placarbil, 20 mg
tablets
Placebo
tablets
Arbaclofen placarbil, 30 mg
tablets
Arbaclofen placarbil, 40 mg
tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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
18 Years
65 Years
ALL
No
Sponsors
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XenoPort, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Indivior Inc.
Locations
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Litchfield Park, Arizona, United States
Anaheim, California, United States
Anaheim, California, United States
San Diego, California, United States
Vista, California, United States
Fort Lauderdale, Florida, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Overland Park, Kansas, United States
Erlanger, Kentucky, United States
Traverse City, Michigan, United States
Brick, New Jersey, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Oklahoma City, Oklahoma, United States
Anderson, South Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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XP-B-083
Identifier Type: -
Identifier Source: org_study_id
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