Clinical trial NCT00817986: A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of XP19986 in Subjects With Acute Back Spasms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Back Pain
Keywords: Acute back pain in the lumbar region
Lead sponsor: XenoPort, Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-07
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 lumbar region.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: 14 Days
Secondary outcomes:
measure: Change in pain severity score using the VAS
timeFrame: 4 Days
Other outcomes:
Locations:
city: Litchfield Park
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Anaheim
country: United States
state: California
city: San Diego
country: United States
state: California
city: Vista
country: United States
state: California
city: Fort Lauderdale
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Overland Park
country: United States
state: Kansas
city: Erlanger
country: United States
state: Kentucky
city: Traverse City
country: United States
state: Michigan
city: Brick
country: United States
state: New Jersey
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Anderson
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Indivior Inc.
name: Study Director
role: STUDY_DIRECTOR
References: