- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02436824
A Study of a Topical Patch (AB001) in Patients With Chronic Low Back Pain
August 28, 2016 updated by: Frontier Biotechnologies Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
146
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33015
- San Marcus Research Clinic, Inc.
-
Naples, Florida, United States, 34102
- Pharma Research International, Inc.
-
-
Georgia
-
Marietta, Georgia, United States, 30060
- Georgia Institute for Clinical Research,LLC
-
-
Kentucky
-
Lexington, Kentucky, United States, 40509
- Central Kentucky Research Associates
-
-
New Jersey
-
Atco, New Jersey, United States, 08004
- Atco Medical Associates, P.C.
-
East Brunswick, New Jersey, United States, 08816
- UniMed Center
-
Fair Lawn, New Jersey, United States, 07410
- TKL Research, Inc.
-
-
South Carolina
-
Spartanburg, South Carolina, United States, 29307
- Upstate Clinical Trials, LLC
-
-
Virginia
-
Danville, Virginia, United States, 24541
- Danville Orthopedic Clinic, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: AB001 patch
Two AB001 patches will be applied to the low back once daily for 14 days.
|
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.
Other Names:
|
PLACEBO_COMPARATOR: Placebo patch
Identical in size and shape to the AB001 patch.
Two placebo patches will be applied to the low back once daily for 14 days.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of Pain intensity on VAS on Day 15
Time Frame: From baseline to Day 15
|
From baseline to Day 15
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of Pain intensity on VAS on Day 8
Time Frame: From baseline to Day 8
|
From baseline to Day 8
|
Change of Subject Global Assessment (SGA) of disease status/low back pain
Time Frame: From baseline to Day 8 and 15
|
From baseline to Day 8 and 15
|
Change of Roland-Morris Disability Questionnaire on low back pain
Time Frame: From baseline to Day 8 and 15
|
From baseline to Day 8 and 15
|
Subject Global Perceived Effect (GPE) of study medication
Time Frame: From baseline to Day 8 and 15
|
From baseline to Day 8 and 15
|
Pain Assessment from Subject Diaries
Time Frame: On Day 1 through Day 3
|
On Day 1 through Day 3
|
Safety Assessments on AEs
Time Frame: From baseline through Day 15
|
From baseline through Day 15
|
Safety Assessments on laboratory test
Time Frame: From baseline through Day 15
|
From baseline through Day 15
|
Safety Assessments on vital signs/physical examinations
Time Frame: From baseline through Day 15
|
From baseline through Day 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Changjin Wang, Frontier Biotechnologies Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (ACTUAL)
July 1, 2015
Study Completion (ACTUAL)
August 1, 2015
Study Registration Dates
First Submitted
April 30, 2015
First Submitted That Met QC Criteria
May 4, 2015
First Posted (ESTIMATE)
May 7, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
August 30, 2016
Last Update Submitted That Met QC Criteria
August 28, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABS-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Iran University of Medical SciencesNot yet recruitingLow Back Pain | Chronic Low-back Pain | Chronic Non-specific Low Back Pain | Cupping Therapy
-
Federal University of Minas GeraisRecruitingBack Pain | Low Back Pain | Chronic Low-back Pain | Back Pain Lower Back ChronicBrazil
-
University of Colorado, BoulderNational Institutes of Health (NIH); Radiological Society of North America; Psychophysiologic... and other collaboratorsCompletedChronic Pain | Back Pain Lower Back Chronic | Back Pain, LowUnited States
-
Federal University of ParaíbaCompletedChronic Low Back Pain | Nonspecific Chronic Low Back Pain
-
Presidio Medical, IncRecruitingChronic Pain | Chronic Low-back PainAustralia
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
Spaulding Rehabilitation HospitalHighland Instruments, Inc.Active, not recruitingChronic Pain | Chronic Low Back PainUnited States
-
University of WashingtonNational Center for Complementary and Integrative Health (NCCIH)Active, not recruiting
-
Dan RhonNational Center for Complementary and Integrative Health (NCCIH); 59th Medical... and other collaboratorsRecruitingLow Back Pain | Chronic Pain | Surgery | Back Pain Lower Back Chronic | Back Pain, LowUnited States
Clinical Trials on AB001 patch
-
Frontier Biotechnologies Inc.CompletedChronic Low Back PainChina
-
Coloplast A/SCompleted
-
Coloplast A/SCompleted
-
En Chu Kong HospitalCompleted
-
Baylor College of MedicineRecruiting
-
University of ZurichCompletedAllergic RhinoconjunctivitisSwitzerland
-
Veradermics, Inc.RecruitingWarts | Common Wart | Verruca VulgarisUnited States
-
Chattem, Inc.CompletedTolerability | Adhesiveness | Dermal Irritation | Effects of HeatUnited States