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

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02436824
• Other study ID #: ABS-201
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2015
• Last updated: August 28, 2016
• Start date: April 2015
• Est. completion date: August 2015

Study information

• Verified date: August 2016
• Source: Frontier Biotechnologies Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Are generally healthy males or non-pregnant females, 18 to 75 years of age.

2. Have a body mass index (BMI) =35.

3. Have chronic low back pain for at least 3 months.

4. Have low back pain that is located inferior to the twelfth thoracic vertebra (T-12).

5. Back pain classified, using the Quebec Task Force system, as either Class 1 or Class 2.

6. Currently require use of analgesics for lower back pain (required at least 3 days per week for at least the last 4 weeks).

7. 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.

8. Are willing to discontinue current analgesics for the 3 to 15 day washout period.

9. 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.

10. 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.

11. Are willing to provide written informed consent.

Exclusion Criteria:

1. 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.

2. Have low back pain caused by major trauma.

3. Have excess hair, tattoo(s), or other dermatologic conditions in the patch application area that might interfere with efficacy evaluation.

4. Have had surgery for low back pain within the previous 6 months.

5. Have had clinical depression within 2 years or are currently undergoing treatment for depression;

6. Have a hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs, including aspirin) or hypersensitivity to acetaminophen.

7. Have used opioids within 72 hours prior to the Baseline / Day 1 visit or during the course of the study.

8. Have used oral or injected corticosteroids chronically or intermittently within the past 60 days (oral), or 90 days (injected).

9. Are a current drug or alcohol abuser.

10. Are pregnant, plan to become pregnant during the study, or are breastfeeding.

11. Have a pending workman's compensation claim, litigation, or any other monetary settlement relating to the subject's lower back pain.

12. 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.

13. Have a history of sensitivity to any component of the investigational product.

14. Have a known history of liver or kidney disorders (hepatic or renal insufficiency).

15. Have a known history of gastric ulcer, gastrointestinal bleeding, or significant cardiovascular events.

16. Have a history of cancer, other than treated basal cell carcinoma, within the past 5 years.

17. 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.

18. 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.

19. Participation in another clinical trial or received an investigational product within 30 days prior to screening.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Drug:
• AB001 patch
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:
• Placebo patch
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.

Locations

Country	Name	City	State
United States	Atco Medical Associates, P.C.	Atco	New Jersey
United States	Danville Orthopedic Clinic, Inc.	Danville	Virginia
United States	UniMed Center	East Brunswick	New Jersey
United States	TKL Research, Inc.	Fair Lawn	New Jersey
United States	Central Kentucky Research Associates	Lexington	Kentucky
United States	Georgia Institute for Clinical Research,LLC	Marietta	Georgia
United States	San Marcus Research Clinic, Inc.	Miami	Florida
United States	Pharma Research International, Inc.	Naples	Florida
United States	Upstate Clinical Trials, LLC	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Frontier Biotechnologies Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Pain intensity on VAS on Day 15		From baseline to Day 15	No
Secondary	Change of Pain intensity on VAS on Day 8		From baseline to Day 8	No
Secondary	Change of Subject Global Assessment (SGA) of disease status/low back pain		From baseline to Day 8 and 15	No
Secondary	Change of Roland-Morris Disability Questionnaire on low back pain		From baseline to Day 8 and 15	No
Secondary	Subject Global Perceived Effect (GPE) of study medication		From baseline to Day 8 and 15	No
Secondary	Pain Assessment from Subject Diaries		On Day 1 through Day 3	No
Secondary	Safety Assessments on AEs		From baseline through Day 15	Yes
Secondary	Safety Assessments on laboratory test		From baseline through Day 15	Yes
Secondary	Safety Assessments on vital signs/physical examinations		From baseline through Day 15	Yes