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

This study has been completed.
Sponsor:
Information provided by:
XenoPort, Inc.
ClinicalTrials.gov Identifier:
NCT00817986
First received: January 6, 2009
Last updated: September 14, 2010
Last verified: September 2010

January 6, 2009
September 14, 2010
December 2008
July 2009   (final data collection date for primary outcome measure)
Incidence of treatment-emergent adverse events [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
Safety was assessed based on the incidence, intensity and relationship of treatment emergent AEs
Incidence of treatment-emergent adverse events, their intensity, their seriousness, the rate of withdrawal due to treatment-emergent adverse events; and changes from baseline in vital signs, and safety laboratory tests [ Time Frame: 14 Days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00817986 on ClinicalTrials.gov Archive Site
Change in pain severity score using the VAS [ Time Frame: 4 Days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of XP19986 in Subjects With Acute Back Spasms

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Back Spasms
  • Drug: Arbaclofen placarbil, 20 mg BID
    After the screening/randomization visit, eligible subjects will be randomized to study treatment (arbaclofen placarbil or placebo) for 14 days with taper period
  • Drug: Placebo
    After the screening/randomization visit, eligible subjects will be randomized to study treatment (arbaclofen placarbil or placebo) for 14 days with taper period
  • Drug: Arbaclofen placarbil, 30 mg BID
    After the screening/randomization visit, eligible subjects will be randomized to study treatment (arbaclofen placarbil or placebo) for 14 days with taper period
  • Drug: Arbaclofen placarbil, 40 mg BID
    After the screening/randomization visit, eligible subjects will be randomized to study treatment (arbaclofen placarbil or placebo) for 14 days with taper period
  • Experimental: Cohort 1
    Intervention: Drug: Arbaclofen placarbil, 20 mg BID
  • Experimental: Cohort 2
    Intervention: Drug: Arbaclofen placarbil, 30 mg BID
  • Experimental: Cohort 3
    Intervention: Drug: Arbaclofen placarbil, 40 mg BID
  • Experimental: Cohort 4
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
161
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00817986
XP-B-083
No
Jay Huff, M.D., Vice President Clinical Development, XenoPort, Inc.
XenoPort, Inc.
Not Provided
Not Provided
XenoPort, Inc.
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP