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Chronic Low Back PainPhase 2NCT02436824

A Study of a Topical Patch (AB001) in Patients With Chronic Low Back Pain

A Phase 2 study testing AB001 patch in people with Chronic Low Back Pain, run by Frontier Biotechnologies Inc. at 9 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

The objectives of this study are to examine the safety, tolerability, and efficacy of repeated topical administration of AB001 topical patches for the treatment of chronic low back pain. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Low Back Pain
What is being tested?
AB001 patch
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
146 participants
Where
9 sitesUnited States
Study dates
Apr 2015to Aug 2015
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Are generally healthy males or non-pregnant females, 18 to 75 years of age.
  • Have a body mass index (BMI) ≤35.
  • Have chronic low back pain for at least 3 months.
  • Have low back pain that is located inferior to the twelfth thoracic vertebra (T-12).
  • Back pain classified, using the Quebec Task Force system, as either Class 1 or Class 2.
  • Currently require use of analgesics for lower back pain (required at least 3 days per week for at least the last 4 weeks).
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  • Have a score of 30 mm or greater on the visual analog scale (VAS) and a score of 2, 3, or 4 on the Subject Global Assessment (SGA) of Back Pain Scale at Screening.
  • Are willing to discontinue current analgesics for the 3 to 15 day washout period.
  • Have an increase of at least 10 mm or more from the score at Screening and an absolute score of 50 mm or more on the VAS (ie, VAS ≥ 50 mm) and a score of 3 or 4 on the SGA of Back Pain Scale at Baseline.
  • If female, are: 1).Of non-childbearing potential or have a confirmed clinical history of sterility or, 2).Of childbearing potential, must be willing to use effective contraception at trial entry and until completion.
  • Are willing to provide written informed consent.

Who cannot join

  • Have chronic lower back pain (CLBP) due to any of the following pathologies: infection, neoplasia, metabolic or structural disturbance of spine, lumbar radiculopathy, osteoporosis, hip dysplasia, inflammatory arthritis, ankylosing spondylitis, Paget's disease, cauda equine syndrome, gout, pseuodgout, fibromyalgia, post-surgical pain.
  • Have low back pain caused by major trauma.
  • Have excess hair, tattoo(s), or other dermatologic conditions in the patch application area that might interfere with efficacy evaluation.
  • Have had surgery for low back pain within the previous 6 months.
  • Have had clinical depression within 2 years or are currently undergoing treatment for depression;
  • Have a hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs, including aspirin) or hypersensitivity to acetaminophen.
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  • Have used opioids within 72 hours prior to the Baseline / Day 1 visit or during the course of the study.
  • Have used oral or injected corticosteroids chronically or intermittently within the past 60 days (oral), or 90 days (injected).
  • Are a current drug or alcohol abuser.
  • Are pregnant, plan to become pregnant during the study, or are breastfeeding.
  • Have a pending workman's compensation claim, litigation, or any other monetary settlement relating to the subject's lower back pain.
  • Have any chronic or acute medical condition that may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this trial.
  • Have a history of sensitivity to any component of the investigational product.
  • Have a known history of liver or kidney disorders (hepatic or renal insufficiency).
  • Have a known history of gastric ulcer, gastrointestinal bleeding, or significant cardiovascular events.
  • Have a history of cancer, other than treated basal cell carcinoma, within the past 5 years.
  • Use of any medication, including prescription, OTC, vitamins, herbal and/or mineral supplements, dietary supplements, enzyme altering agents within at least14 days prior to the first treatment or during the trial, which may influence the trial results.
  • Use of anti-coagulant medication within the past 30 days, including but not limited to heparins, warfarin/Coumadin, rivaroxaban/Xarelto, dabigatran/Pradaxa, apixaban/Eliquis, etc.
  • Participation in another clinical trial or received an investigational product within 30 days prior to screening.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Atco Medical Associates, P.C.

    Atco, New Jersey, 08004

  • Danville Orthopedic Clinic, Inc.

    Danville, Virginia, 24541

  • UniMed Center

    East Brunswick, New Jersey, 08816

  • TKL Research, Inc.

    Fair Lawn, New Jersey, 07410

  • Central Kentucky Research Associates

    Lexington, Kentucky, 40509

  • Georgia Institute for Clinical Research,LLC

    Marietta, Georgia, 30060

  • San Marcus Research Clinic, Inc.

    Miami, Florida, 33015

  • Pharma Research International, Inc.

    Naples, Florida, 34102

  • Upstate Clinical Trials, LLC

    Spartanburg, South Carolina, 29307

Other trials in United States

About this study

Official title: A Phase II, Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Determine the Safety and Efficacy of a Topical Patch (AB001) Following Daily Administration for 2 Weeks in Patients With Chronic Low Back Pain

The objectives of this study are to examine the safety, tolerability, and efficacy of repeated topical administration of AB001 topical patches for the treatment of chronic low back pain.

Read the detailed description

This is a randomized, double-blind, placebo-controlled, parallel-group study of the safety and efficacy of AB001 topical patches in patients with chronic low back pain. Subjects meeting inclusion criteria are randomized in a 1:1 ratio to receive AB001 patches or placebo patches. Two AB001 or placebo patches will be given topically once daily for 14 days. The primary end point is the change of low back pain intensity rated on a visual analog scale (VAS) scale on Day 15, the secondary end points include the subject global assessment (SGA) of low back pain, the subject global perceived effect (GPE) of study medication, the Roland-Morris Disability Questionnaire (RMDQ), and the pain assessment from subject diary (Days 1 - 3 only). Subjects' safety will be monitored throughout the study, including the adverse event (AE) incidence and severity, laboratory test results (hematology and clinical chemistry), vital signs, and physical examination.

Being tested
AB001 patch, Placebo patch
Keywords
topical patch, chronic low back pain

What participants receive

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

  • AB001 patchDrug

    Also called AB001

    Two AB001 patches will be applied to the low back once daily for 14 days, the patches shall be removed after approximately 12 hours after daily application.

  • Placebo patchOther

    Two placebo patches will be applied to the low back once daily for 14 days, the patches shall be removed after approximately 12 hours after daily application.

Study groups in NCT02436824
Study groupRoleWhat they receive
AB001 patchExperimentalTwo AB001 patches will be applied to the low back once daily for 14 days.
Receives: Drug: AB001 patch
Placebo patchPlacebo comparatorIdentical in size and shape to the AB001 patch. Two placebo patches will be applied to the low back once daily for 14 days.
Receives: Other: Placebo patch

What is being measured

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

  1. Change of Pain intensity on VAS on Day 15

    Measured: From baseline to Day 15

Secondary outcomes (8)

  1. Change of Pain intensity on VAS on Day 8

    Measured: From baseline to Day 8

  2. Change of Subject Global Assessment (SGA) of disease status/low back pain

    Measured: From baseline to Day 8 and 15

  3. Change of Roland-Morris Disability Questionnaire on low back pain

    Measured: From baseline to Day 8 and 15

  4. Subject Global Perceived Effect (GPE) of study medication

    Measured: From baseline to Day 8 and 15

  5. Pain Assessment from Subject Diaries

    Measured: On Day 1 through Day 3

  6. Safety Assessments on AEs

    Measured: From baseline through Day 15

  7. Safety Assessments on laboratory test

    Measured: From baseline through Day 15

  8. Safety Assessments on vital signs/physical examinations

    Measured: From baseline through Day 15

Timeline

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

  1. First posted7 May 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionJul 2015
  4. Study completionAug 2015

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02436824
Sponsor's protocol ID
ABS-201
Status last verified
Aug 2016
First submitted
30 Apr 2015
Last updated
30 Aug 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AB001 patch in people with Chronic Low Back Pain, run by Frontier Biotechnologies Inc. at 9 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 11 inclusion and 19 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 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

Change of Pain intensity on VAS on Day 15 (time frame: From baseline to Day 15). 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 NCT02436824.

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 30 Aug 2016.

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