NCT02436824

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

April 30, 2015

Last Update Submit

August 28, 2016

Conditions

Chronic Low Back Pain

Keywords

topical patchchronic low back pain

Outcome Measures

Primary Outcomes (1)

  • Change of Pain intensity on VAS on Day 15

    From baseline to Day 15

Secondary Outcomes (8)

  • Change of Pain intensity on VAS on Day 8

    From baseline to Day 8

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

    From baseline to Day 8 and 15

  • Change of Roland-Morris Disability Questionnaire on low back pain

    From baseline to Day 8 and 15

  • Subject Global Perceived Effect (GPE) of study medication

    From baseline to Day 8 and 15

  • Pain Assessment from Subject Diaries

    On Day 1 through Day 3

  • +3 more secondary outcomes

Study Arms (2)

AB001 patch

EXPERIMENTAL

Two AB001 patches will be applied to the low back once daily for 14 days.

Drug: AB001 patch

Placebo patch

PLACEBO COMPARATOR

Identical in size and shape to the AB001 patch. Two placebo patches will be applied to the low back once daily for 14 days.

Other: Placebo patch

Interventions

AB001 patchDRUG

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.

Also known as: AB001
AB001 patch
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.

Placebo patch

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

San Marcus Research Clinic, Inc.

Miami, Florida, 33015, United States

Location

Pharma Research International, Inc.

Naples, Florida, 34102, United States

Location

Georgia Institute for Clinical Research,LLC

Marietta, Georgia, 30060, United States

Location

Central Kentucky Research Associates

Lexington, Kentucky, 40509, United States

Location

Atco Medical Associates, P.C.

Atco, New Jersey, 08004, United States

Location

UniMed Center

East Brunswick, New Jersey, 08816, United States

Location

TKL Research, Inc.

Fair Lawn, New Jersey, 07410, United States

Location

Upstate Clinical Trials, LLC

Spartanburg, South Carolina, 29307, United States

Location

Danville Orthopedic Clinic, Inc.

Danville, Virginia, 24541, United States

Location

Study Officials

  • Changjin Wang

    Frontier Biotechnologies Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2015

First Posted

May 7, 2015

Study Start

April 1, 2015

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

August 30, 2016

Record last verified: 2016-08

Locations

US(9)