Back PainPhase 2NCT00817986
A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms
A Phase 2 study testing Arbaclofen placarbil, 20 mg, Arbaclofen placarbil, 30 mg and Arbaclofen placarbil, 40 mg in people with Back Pain, run by XenoPort, Inc. at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Arbaclofen placarbil, 20 mg, Arbaclofen placarbil, 30 mg and Arbaclofen placarbil, 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 20 sitesUnited States
- Study dates
- Dec 2008to Jul 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Study site
Anaheim, California, 92084
Study site
Anaheim, California, 92801
Study site
Anderson, South Carolina, 29621
Study site
Atlanta, Georgia, 30308
Study site
Brick, New Jersey, 07732
Study site
Dallas, Texas, 75234
Study site
Erlanger, Kentucky, 41018
Study site
Fort Lauderdale, Florida, 33306
Study site
Houston, Texas, 77074
Study site
Litchfield Park, Arizona, 85340
Study site
Miami, Florida, 33143
Study site
Oklahoma City, Oklahoma, 73122
Study site
Overland Park, Kansas, 66211
Study site
Raleigh, North Carolina, 27612
Study site
Salt Lake City, Utah, 84106
Study site
San Antonio, Texas, 78215
Study site
San Diego, California, 92128
Study site
Traverse City, Michigan, 49684
Study site
Vista, California, 92083
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: 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.
- Conditions
- Back Pain
- Being tested
- Arbaclofen placarbil, 20 mg, Placebo, Arbaclofen placarbil, 30 mg, Arbaclofen placarbil, 40 mg
- Keywords
- Acute back pain in the lumbar region
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arbaclofen placarbil, 20 mgDrug
Also called XP19986 SR3
tablets
PlaceboDrug
Also called Sugar Pill
tablets
Arbaclofen placarbil, 30 mgDrug
Also called XP19986 SR3
tablets
Arbaclofen placarbil, 40 mgDrug
Also called XP19986 SR3 tablets
tablets
| Study group | Role | What they receive |
|---|---|---|
| Arbaclofen placarbil 20 mg | Experimental | Arbaclofen placarbil 20 mg, BID, for 14 days including the taper period. Receives: Drug: Arbaclofen placarbil, 20 mg |
| Placebo for Arbaclofen placarbil | Placebo comparator | Placebo for 14 days Receives: Drug: Placebo |
| Arbaclofen placarbil 30 mg | Experimental | Arbaclofen placarbil 30 mg, BID, for 14 days including the taper period. Receives: Drug: Arbaclofen placarbil, 30 mg |
| Arbaclofen placarbil 40 mg | Experimental | Arbaclofen placarbil 40 mg, BID, for 14 days including the taper period. Receives: Drug: Arbaclofen placarbil, 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Safety was assessed based on the incidence, intensity and relationship of treatment emergent AEs
Measured: 14 Days
Secondary outcomes (1)
Change in pain severity score using the VAS
Measured: 4 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- XenoPort, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Indivior Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817986
- Sponsor's protocol ID
- XP-B-083
- Status last verified
- Feb 2021
- First submitted
- 6 Jan 2009
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of XP19986 in Subjects With Acute Back Spasms
- ClinicalTrials.gov ID
- NCT00817986
- Acronym / sponsor ID
- XP-B-083
- Conditions
- Back Pain
- Keywords
- Acute back pain in the lumbar region
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- XenoPort, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 7 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arbaclofen placarbil 20 mg | Experimental | Drug: Arbaclofen placarbil, 20 mgArbaclofen placarbil 20 mg, BID, for 14 days including the taper period. |
| Placebo for Arbaclofen placarbil | Placebo comparator | Drug: PlaceboPlacebo for 14 days |
| Arbaclofen placarbil 30 mg | Experimental | Drug: Arbaclofen placarbil, 30 mgArbaclofen placarbil 30 mg, BID, for 14 days including the taper period. |
| Arbaclofen placarbil 40 mg | Experimental | Drug: Arbaclofen placarbil, 40 mgArbaclofen placarbil 40 mg, BID, for 14 days including the taper period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- Or
- 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).
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arbaclofen placarbil, 20 mgAlso: XP19986 SR3tablets | Drug | Arbaclofen placarbil 20 mg |
| PlaceboAlso: Sugar Pilltablets | Drug | Placebo for Arbaclofen placarbil |
| Arbaclofen placarbil, 30 mgAlso: XP19986 SR3tablets | Drug | Arbaclofen placarbil 30 mg |
| Arbaclofen placarbil, 40 mgAlso: XP19986 SR3 tabletstablets | Drug | Arbaclofen placarbil 40 mg |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: 14 Days
Safety was assessed based on the incidence, intensity and relationship of treatment emergent AEs
1 secondary outcome
Change in pain severity score using the VAS
Time frame: 4 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Back Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Indivior Inc.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arbaclofen placarbil, 20 mg, Arbaclofen placarbil, 30 mg and Arbaclofen placarbil, 40 mg in people with Back Pain, run by XenoPort, Inc. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: 14 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.