The Analgesic Activity of a Topical Formulation in Patients With Osteoarthritis of the Hands

June 25, 2015 updated by: Transdermal Therapeutics, Inc.

Osteoarthritis (OA) affects over 30 million people in the United States and represents our nation's leading cause of disability. Data for the years between 1996-2005, indicate that OA raised overall health care costs by $185.5 billion annually. Largely as a consequence of this disease, the number of patients undergoing joint replacement surgery will quadruple over the next 17 years. Importantly, several recent studies have demonstrated that OA is an independent risk factor for cardiovascular disease . Presently investigators have no medications that alter the natural history of OA. Weight control, exercise and some physical therapy measures are the only interventions short of total joint replacement that alter the course of this disease. To make matters worse, investigators have experienced only setbacks in use of medications aimed at symptom control. Recognition of toxicities of non-steroidal anti-inflammatory drugs (NSAIDs) and narcotic-based analgesics has narrowed the presently available armamentarium for pain control in OA . Clearly OA is a major factor that demands better solutions as the health care system is redesigned.

OA involving the hands represents a major part of the overall burden of this disease. In radiographic surveys about a quarter of the total US population has changes consistent with OA involving the hands. Among the elderly, radiographic hand OA has been found in over half of such individuals and as many as a quarter of them suffer from pain and functional incapacitation. The joints affected typically are the first carpometacarpal (CMC-1) joint, the distal interphalangeal (DIP) joints, and the proximal interphalangeal (PIP) joints . Therapeutic options include acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and a variety of physical measures such as physical therapy, bracing, and heat and cold applications. To achieve some symptomatic benefit while limiting systemic toxicity, topical therapies have been developed which either act as counter irritants, seek to reduce substance P (capsaicin), or to deliver an NSAID locally through the skin. The leading example of the latter is Diclofenac sodium gel which was shown to reduce pain intensity and improve hand function in a double blind controlled trial. However none of these measures have proven sufficiently effective to meet patient needs. Topical polytherapy will be employed in this study to see if it will be effective against the pain of OA.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A potentially more effective approach is to provide a combination of analgesic and anti-inflammatory agents through a topical delivery system. In the present study compounds with anti-inflammatory and analgesic properties will be combined in a vehicle that promotes penetration of molecules through the skin to deeper underlying tissues such as the joint capsule at articulations in the hands. The vehicle consists of Versapro cream base (a formulation of Medisca, Inc. that contains Vitamin E and Aloe Vera, along with other ingredients that are proprietary), Tranilast powder, Pentoxifylline USP powder, Cetyl Myristoleate 40% wax, liquid Pentylene Glycol, liquid Dimethyl Sulfoxide (DMSO) USP, liquid Propylene Glycol USP, liquid Ethoxy Diglycol reagent, liquid Ethyl Alcohol 190 proof USP. These are all inert ingredients, i.e. they only promote penetration of molecules through the skin. A mixture of the following compounds will be incorporated into this vehicle as the active test medication:

Diclofenac 3% - an NSAID. FDA pregnancy category C for the first 30 weeks, then category D.

Baclofen 2% - an agonist for the GABAB receptors. FDA pregnancy category C.

Orphenadrine 5% - an anticholinergic drug of the ethanolamine antihistamine class. FDA pregnancy category C.

Bupivacaine 2% - a local anesthetic that binds voltage-gated sodium channels and blocks sodium influx into nerve cells preventing depolarization. FDA pregnancy category C.

Due to the FDA pregnancy categories for the drugs used in this study, pregnancy is an exclusion criteria.

The control medication: The vehicle alone will serve as the control compound.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • OA in at least one hand as defined by ACR Criteria (nodal enlargement in two or more of 10 defined joints, CMC-1, MCP=1, PIPs and DIPs).
  • Hand pain duration greater than one year.
  • History of NSAID use for hand pain on at least one occasion during the last year.
  • Age 40 to 79 years.
  • Ability to understand the English language and to comprehend written material at the 5th grade level.

Exclusion Criteria:

  • History of psoriasis
  • Other painful rheumatic disease, measured by a blood draw that will test for RF factor and ESR.
  • Rheumatoid arthritis, as measured by hand x-rays.
  • Any diagnosis of fibromyalgia or neurovascular disease.
  • Presence of Raynaud's disease.
  • -Presence of Raynaud's disease.
  • Presence of any peripheral neuropathy.
  • Presence of cervical radiculopathy.
  • Pregnancy in females (pregnancy test will be administered at intake to females of reproductive capability and their method of birth control recorded.)
  • Persons under age 40. Insufficient data are available in adults to judge potential risk in children.
  • Those who are not capable of providing informed consent.
  • Known allergy to analgesic drugs and the drugs used in this study.
  • Those who do not comprehend English. As this is a short-term Pilot study, the potential benefits to the participants is currently unknown. Based upon this knowledge, we believe we are exempt from the requirement to translate the informed consent form into Spanish.
  • Those with renal and/or gastrointestinal impairments, i.e. with a creatinine level of 2 and GFS level 4.

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: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A/B
In this crossover trial, the A/B group will receive the test product (A) and then the placebo (B). The topical product contains the following: Diclofenac 3%, Baclofen 2%, Orphenadrine Citrate 5% and Bupivacaine 2% in a VersaPro cream, while the placebo is the VersaPro cream alone. Participants will use the test product for 7 days, applying the topical product to the hands twice a day. There will be a 7 day washout period, and then participants will be given the placebo cream, which will be used for 7 days, applying the topical placebo to the hands twice a day.
Drug: A/B
This arm uses the test product first, which consists of Diclofenac 3%, Baclofen 2%, Orphenadrine 5%, and Bupivacaine 2% in a VersaPro cream. This is the A arm. The B arm is the second arm, and consists of the VersaPro cream alone.
Other Names:
  • Diclofenac 3%
  • Baclofen 2%
  • Orphenadrine 5%
  • Bupivacaine 2%
  • VersaPro cream
Drug: Placebo
The placebo, which consists of the VersaPro cream, will be utilized in the study.
Other Names:
  • VersaPro cream
Experimental: B/A
In this crossover trial, the B/A group will receive the placebo (B) and then the test product (A). The product contains the following: Diclofenac 3%, Baclofen 2%, Orphenadrine Citrate 5% and Bupivacaine 2% in a VersaPro cream, while the placebo is the VersaPro cream alone. Participants will use the placebo product for 7 days, applying the placebo product to the hands twice a day. There will be a 7 day washout period, and then participants will be given the test cream, which will be used for 7 days, applying the topical product to the hands twice a day.
Drug: Placebo
The placebo, which consists of the VersaPro cream, will be utilized in the study.
Other Names:
  • VersaPro cream
Drug: B/A
This arm uses the placebo product first, which consists of the VersaPro cream alone. This is the B arm. The A arm is the second arm, which consists of the test product which consists of Diclofenac 3%, Baclofen 2%, Orphenadrine 5%, and Bupivacaine 2% in a VersaPro cream. This is the A arm.
Other Names:
  • Diclofenac 3%
  • Baclofen 2%
  • Orphenadrine 5%
  • Bupivacaine 2%
  • VersaPro cream

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
100 mm Visual Analog Scale
Time Frame: Participants will be followed for the 28 days of the study length, with the study measure being given at study day 7, study day 14, study day 21 and study day 28.
Measurement of OA pain intensity
Participants will be followed for the 28 days of the study length, with the study measure being given at study day 7, study day 14, study day 21 and study day 28.
Australia/Canadian Osteoarthritis Index
Time Frame: Participants will be followed for the 28 days of the study length, with the study measure being given at study day 7, study day 14, study day 21 and study day 28.
Measurement of osteoarthritis hand function
Participants will be followed for the 28 days of the study length, with the study measure being given at study day 7, study day 14, study day 21 and study day 28.
100 mm Visual Analog Scale
Time Frame: Participants will be followed for the 28 days of the study length, with the study measure being given at study day 7, study day 14, study day 21 and study day 28.
Global rating of disease activity
Participants will be followed for the 28 days of the study length, with the study measure being given at study day 7, study day 14, study day 21 and study day 28.
Composite Pharmacokinetics
Time Frame: Blood will be drawn at study day 7, study day 14, study day 21, and study day 28
Participants will be followed for the 28 days of the study length, with the pharmacokinetics being tested at study day 7, study day 14, study day 21 and study day 28 to see the systemic absorption of each of the study drugs. Each drug (Diclofenac, Baclofen, Orphenadrine and Bupivacaine) will be tested for Peak Plasma Concentration (C max) and the area under the plasma concentration versus time curve (AUC).
Blood will be drawn at study day 7, study day 14, study day 21, and study day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Use of rescue medication
Time Frame: The entire 28 day study
Acetaminophen up to 4 grams daily.
The entire 28 day study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Transdermal Therapeutics, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Albert Einstein College of Medicine
Montefiore Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Hardin, M.D., Albert Einstein College of Medicine - Yeshiva University and Montefiore Medical Center

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 54321

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 Osteoarthritis of the Hands

Clinical Trials on A/B

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings