A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms
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ClinicalTrials.gov Identifier: NCT00817986 |
Recruitment Status
:
Completed
First Posted
: January 7, 2009
Last Update Posted
: September 23, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Back Pain | Drug: Arbaclofen placarbil, 20 mg Drug: Placebo Drug: Arbaclofen placarbil, 30 mg Drug: Arbaclofen placarbil, 40 mg | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 161 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of XP19986 in Subjects With Acute Back Spasms |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | July 2009 |
Actual Study Completion Date : | July 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: Arbaclofen placarbil 20 mg
Arbaclofen placarbil 20 mg, BID, for 14 days including the taper period.
|
Drug: Arbaclofen placarbil, 20 mg
tablets
Other Name: XP19986 SR3
|
Placebo Comparator: Placebo for Arbaclofen placarbil
Placebo for 14 days
|
Drug: Placebo
tablets
Other Name: Sugar Pill
|
Experimental: Arbaclofen placarbil 30 mg
Arbaclofen placarbil 30 mg, BID, for 14 days including the taper period.
|
Drug: Arbaclofen placarbil, 30 mg
tablets
Other Name: XP19986 SR3
|
Experimental: Arbaclofen placarbil 40 mg
Arbaclofen placarbil 40 mg, BID, for 14 days including the taper period.
|
Drug: Arbaclofen placarbil, 40 mg
tablets
Other Name: XP19986 SR3 tablets
|
- Incidence of treatment-emergent adverse events [ Time Frame: 14 Days ]Safety was assessed based on the incidence, intensity and relationship of treatment emergent AEs
- Change in pain severity score using the VAS [ Time Frame: 4 Days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00817986
United States, Arizona | |
Litchfield Park, Arizona, United States, 85340 | |
United States, California | |
Anaheim, California, United States, 92084 | |
Anaheim, California, United States, 92801 | |
San Diego, California, United States, 92128 | |
Vista, California, United States, 92083 | |
United States, Florida | |
Fort Lauderdale, Florida, United States, 33306 | |
Miami, Florida, United States, 33143 | |
United States, Georgia | |
Atlanta, Georgia, United States, 30308 | |
United States, Kansas | |
Overland Park, Kansas, United States, 66211 | |
United States, Kentucky | |
Erlanger, Kentucky, United States, 41018 | |
United States, Michigan | |
Traverse City, Michigan, United States, 49684 | |
United States, New Jersey | |
Brick, New Jersey, United States, 07732 | |
United States, North Carolina | |
Raleigh, North Carolina, United States, 27612 | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, Oklahoma | |
Oklahoma City, Oklahoma, United States, 73122 | |
United States, South Carolina | |
Anderson, South Carolina, United States, 29621 | |
United States, Texas | |
Dallas, Texas, United States, 75234 | |
Houston, Texas, United States, 77074 | |
San Antonio, Texas, United States, 78215 | |
United States, Utah | |
Salt Lake City, Utah, United States, 84106 |
Study Director: | Study Director | Indivior Inc. |
Responsible Party: | Indivior Inc. |
ClinicalTrials.gov Identifier: | NCT00817986 History of Changes |
Other Study ID Numbers: |
XP-B-083 |
First Posted: | January 7, 2009 Key Record Dates |
Last Update Posted: | September 23, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Indivior Inc.:
Acute back pain in the lumbar region |
Additional relevant MeSH terms:
Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Arbaclofen placarbil Baclofen Muscle Relaxants, Central |
Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents GABA-B Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |