Chronic Low Back PainPhase 2NCT01096966

Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain

A Phase 2 study testing Bupivacaine TTS (Bupivacaine Patch) in people with Chronic Low Back Pain, run by Durect at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the efficacy and safety of Bupivacaine TTS (Bupivacaine patch) compared to placebo in patients with chronic low back pain. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chronic Low Back Pain
What is being tested?: Bupivacaine TTS (Bupivacaine Patch)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 263 participants
Where: 21 sitesUnited States
Study dates: Mar 2010to Feb 2011
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of chronic low back pain for more than 3 months
If taking non-steroidal anti-inflammatory drugs or non-opioid analgesics, must be on a regular, scheduled dose for at least 4 weeks prior to the first visit and intend to remain on a stable dose of these agents for the study duration
Pain intensity score greater than or equal to 5 out of 10 at the first visit
Able to apply patches at home
Able and willing to complete daily pain intensity ratings using an electronic diary device for the duration of the study
Females of childbearing potential must agree to use a medically acceptable method of contraception throughout the study

Who cannot join

History of, or ongoing, alcohol or drug abuse
Positive drug test for alcohol, illicit drug use or opioids
Primary diagnosis of chronic low back pain due to neuropathic pain
History of back surgery or plan for back surgery
Use of opioids within 2 weeks of the first visit and during the study
Previous ineffective use of lidocaine patches

Show all 11Show fewer

Morbid obesity
Moderate or severe depression
An open skin lesion within the painful area where patches will be applied
Patients with active or resolved back pain litigation or receiving disability payments due to chronic low back pain
Pregnant or breastfeeding females

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

Study site
Allentown, Pennsylvania, 18103
Study site
Altoona, Pennsylvania, 16602
Study site
Austin, Texas, 78756
Study site
Dallas, Texas, 75231
Study site
Fort Lauderdale, Florida, 33306
Study site
Gainesville, Florida, 32605
Study site
Houston, Texas, 77074
Study site
La Mesa, California, 91942
Study site
Longwood, Florida, 32779
Study site
Marietta, Georgia, 30060
Study site
New York, New York, 10004
Study site
Newnan, Georgia, 30265
Study site
Oklahoma City, Oklahoma, 73109
Study site
Philadelphia, Pennsylvania, 19139
Study site
Richmond, Virginia, 23294
Study site
Springfield, Massachusetts, 01103
Study site
St Louis, Missouri, 63141
Study site
Tempe, Arizona, 85283
Study site
Torrance, California, 90502
Study site
West Palm Beach, Florida, 33409
Study site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Bupivacaine TTS (Bupivacaine Patch) in Patients With Chronic Low Back Pain

This study will evaluate the efficacy and safety of Bupivacaine TTS (Bupivacaine patch) compared to placebo in patients with chronic low back pain.

Conditions: Chronic Low Back Pain
Being tested: Bupivacaine TTS (Bupivacaine Patch), Placebo patch
Keywords: chronic low back pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bupivacaine TTS (Bupivacaine Patch)Drug
Contains bupivacaine base, in a flexible and rectangular-shaped, transdermal, delivery system. Three patches applied to the lower back every 72 hours for 12 weeks.
Placebo patchDrug
Identical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks.

Study groups in NCT01096966
Study group	Role	What they receive
Bupivacaine TTS	Experimental	Not described Receives: Drug: Bupivacaine TTS (Bupivacaine Patch)
Placebo patch	Placebo comparator	Not described Receives: Drug: Placebo patch

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean change from baseline to 12 weeks in pain in the last 24 hours (daily scores averaged over 14 days)
Measured: baseline to 12 weeks after baseline

Secondary outcomes (2)

Subjects achieving 20% pain relief at 12 weeks compared to baseline
Measured: baseline to 12 weeks after baseline
Subjects 'much improved' or 'very much improved' at 12 weeks
Measured: 12 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Feb 2011

First posted31 Mar 2010 (estimated)
Study startMar 2010
Primary completionFeb 2011
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Low 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 263 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01096966
Sponsor's protocol ID: K843-09-2001
Status last verified: Jun 2022
First submitted: 30 Mar 2010
Last updated: 15 Jun 2022
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

All Chronic Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Bupivacaine TTS (Bupivacaine Patch) in Patients With Chronic Low Back Pain
ClinicalTrials.gov ID: NCT01096966
Acronym / sponsor ID: K843-09-2001
Conditions: Chronic Low Back Pain
Keywords: chronic low back pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 263 participants (actual)
Lead sponsor: DurectIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Mar 2010
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 31 Mar 2010 (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.

This study will evaluate the efficacy and safety of Bupivacaine TTS (Bupivacaine patch) compared to placebo in patients with chronic low back pain.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Bupivacaine TTS	Experimental	Drug: Bupivacaine TTS (Bupivacaine Patch)
Placebo patch	Placebo comparator	Drug: Placebo patch

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Diagnosis of chronic low back pain for more than 3 months
If taking non-steroidal anti-inflammatory drugs or non-opioid analgesics, must be on a regular, scheduled dose for at least 4 weeks prior to the first visit and intend to remain on a stable dose of these agents for the study duration
Pain intensity score greater than or equal to 5 out of 10 at the first visit
Able to apply patches at home
Able and willing to complete daily pain intensity ratings using an electronic diary device for the duration of the study

Key exclusion criteria (11 listed)

History of, or ongoing, alcohol or drug abuse
Positive drug test for alcohol, illicit drug use or opioids
Primary diagnosis of chronic low back pain due to neuropathic pain
History of back surgery or plan for back surgery
Use of opioids within 2 weeks of the first visit and during the study

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
Bupivacaine TTS (Bupivacaine Patch)Contains bupivacaine base, in a flexible and rectangular-shaped, transdermal, delivery system. Three patches applied to the lower back every 72 hours for 12 weeks.	Drug	Bupivacaine TTS
Placebo patchIdentical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks.	Drug	Placebo patch

Primary outcome

Mean change from baseline to 12 weeks in pain in the last 24 hours (daily scores averaged over 14 days)
Time frame: baseline to 12 weeks after baseline

2 secondary outcomes

Subjects achieving 20% pain relief at 12 weeks compared to baseline
Time frame: baseline to 12 weeks after baseline
Subjects 'much improved' or 'very much improved' at 12 weeks
Time frame: 12 weeks after baseline

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 15 Jun 2022.

Related trials for Chronic 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
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic 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.

Paul Meisner, PharmD study director

King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

21 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 Bupivacaine TTS (Bupivacaine Patch) in people with Chronic Low Back Pain, run by Durect at 21 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 6 inclusion and 11 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 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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?

Mean change from baseline to 12 weeks in pain in the last 24 hours (daily scores averaged over 14 days) (time frame: baseline to 12 weeks after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01096966.

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 15 Jun 2022.