Expired Study
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Fort Lauderdale, Florida 33306


Purpose:

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.


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


Study is Available At:


Original ID:

XP-B-083


NCT ID:

NCT00817986


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

XenoPort, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

161


Enrollment Type:

Actual


Study Dates

Start Date:December 2008
Completion Date:July 2009
Completion Type:Actual
Primary Completion Date:July 2009
Primary Completion Type:Actual
Verification Date:September 2010
Last Changed Date:September 14, 2010
First Received Date:January 6, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in pain severity score using the VAS
Time Frame:4 Days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Incidence of treatment-emergent adverse events
Time Frame:14 Days
Safety Issues:True
Description:Safety was assessed based on the incidence, intensity and relationship of treatment emergent AEs

Study Interventions

Intervention Type:Drug
Name:Arbaclofen placarbil, 20 mg BID
Description:After the screening/randomization visit, eligible subjects will be randomized to study treatment (arbaclofen placarbil or placebo) for 14 days with taper period
Arm Name:Cohort 1
Intervention Type:Drug
Name:Placebo
Description:After the screening/randomization visit, eligible subjects will be randomized to study treatment (arbaclofen placarbil or placebo) for 14 days with taper period
Arm Name:Cohort 4
Intervention Type:Drug
Name:Arbaclofen placarbil, 30 mg BID
Description:After the screening/randomization visit, eligible subjects will be randomized to study treatment (arbaclofen placarbil or placebo) for 14 days with taper period
Arm Name:Cohort 2
Intervention Type:Drug
Name:Arbaclofen placarbil, 40 mg BID
Description:After the screening/randomization visit, eligible subjects will be randomized to study treatment (arbaclofen placarbil or placebo) for 14 days with taper period
Arm Name:Cohort 3

Study Arms

Study Arm Type:Experimental
Arm Name:Cohort 1
Study Arm Type:Experimental
Arm Name:Cohort 2
Study Arm Type:Experimental
Arm Name:Cohort 3
Study Arm Type:Experimental
Arm Name:Cohort 4

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:XenoPort, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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