Osteoarthritis of the HandsEarly Phase 1NCT02485145
The Analgesic Activity of a Topical Formulation in Patients With Osteoarthritis of the Hands
A Early Phase 1 study testing A/B and B/A in people with Osteoarthritis of the Hands, run by Transdermal Therapeutics, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Osteoarthritis of the Hands
- What is being tested?
- A/B and B/A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Mar 2016
- Phase
- Early Phase 1
- 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 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Osteoarthritis of the Hands
- Being tested
- A/B, Placebo, B/A
- Keywords
- Topical, Hand osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A/BDrug
Also called Diclofenac 3%, Baclofen 2%, Orphenadrine 5%, Bupivacaine 2%
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.
PlaceboDrug
Also called VersaPro cream
The placebo, which consists of the VersaPro cream, will be utilized in the study.
B/ADrug
Also called Diclofenac 3%, Baclofen 2%, Orphenadrine 5%, Bupivacaine 2%
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.
| Study group | Role | What they receive |
|---|---|---|
| A/B | Experimental | 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. Receives: Drug: A/B; Drug: Placebo |
| B/A | Experimental | 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. Receives: Drug: Placebo; Drug: B/A |
What is being measured
The primary outcome is the main question the study is designed to answer.
100 mm Visual Analog Scale
Measurement of OA pain intensity
Measured: 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
Measurement of osteoarthritis hand function
Measured: 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
Global rating of disease activity
Measured: 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
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).
Measured: Blood will be drawn at study day 7, study day 14, study day 21, and study day 28
Secondary outcomes (1)
Use of rescue medication
Acetaminophen up to 4 grams daily.
Measured: The entire 28 day study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the HandsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transdermal Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Albert Einstein College of Medicine, Montefiore Medical Center
- Responsible party
- Sponsor
- Investigators
- John Hardin, M.D., Principal investigator, Albert Einstein College of Medicine - Yeshiva University and Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485145
- Sponsor's protocol ID
- 54321
- Status last verified
- Jun 2015
- First submitted
- 17 Jun 2015
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Activity of a Topical Formulation in Patients With Osteoarthritis of the Hands
- ClinicalTrials.gov ID
- NCT02485145
- Acronym / sponsor ID
- 54321
- Conditions
- Osteoarthritis of the Hands
- Keywords
- Topical, Hand osteoarthritis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Transdermal Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Albert Einstein College of Medicine, Montefiore Medical Center
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A/B | Experimental | Drug: A/B, Drug: PlaceboIn 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. |
| B/A | Experimental | Drug: Placebo, Drug: B/AIn 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. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A/BAlso: Diclofenac 3%, Baclofen 2%, Orphenadrine 5%, Bupivacaine 2%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. | Drug | A/B |
| PlaceboAlso: VersaPro creamThe placebo, which consists of the VersaPro cream, will be utilized in the study. | Drug | A/B, B/A |
| B/AAlso: Diclofenac 3%, Baclofen 2%, Orphenadrine 5%, Bupivacaine 2%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. | Drug | B/A |
Primary outcome
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
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
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
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).
1 secondary outcome
Use of rescue medication
Time frame: The entire 28 day study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Hardin, M.D. principal investigator
Albert Einstein College of Medicine - Yeshiva University and Montefiore Medical Center
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing A/B and B/A in people with Osteoarthritis of the Hands, run by Transdermal Therapeutics, Inc..
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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ann Ribe, B.A. (205-917-5432, annribe@transdermalinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2015.