Osteoarthritis, KneePhase 3NCT00077935
Civamide in OA of the Knee(s)
A Phase 3 study testing Civamide in people with Osteoarthritis, Knee, run by Winston Laboratories at 34 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis (OA) of the Knee(s). Read more about this study
- Who is it for?
- Ages 40 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Civamide
- How many people
- 351 participants
- Where
- 34 sitesUnited States
- Study dates
- Nov 2003to Jul 2005
- Phase
- Phase 3
- 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 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent.
- Subject has participated (and not withdrawn secondary to any adverse event) in the Phase 3 Osteoarthritis Study WL-1001-05-01 and completed End-of-Study/Final Visit preferably < 30 days prior to Day 1 of this study (WL-1001-05-04).
- Subject is between 40 and 76 years of age.
- Subject is generally in good health.
- Subject is expected to be compliant with study procedures.
- Female subjects of child-bearing potential must have a negative urine pregnancy test at Day 1.
- Female subjects of child-bearing potential agree to use an approved form of contraception and must be on the same contraceptive method and dosage schedule during the entire study.
Who cannot join
- Presence of tendonitis, bursitis, partial or complete joint replacement of knee(s).
- Presence of active skin disease, erythema, infection, wound, or irritation near the treatment area of the knee(s).
- Subject has an anticipated need for any surgical or other invasive procedure (e.g., synovial fluid aspiration, arthroscopy, tidal joint irrigation, injectable medications) that will be performed on the knees during the course of the study.
- Subject has a history and/or diagnosis of rheumatoid arthritis, fibromyalgia, connective tissue disease, psoriatic arthritis, erosive inflammatory OA, diffuse idiopathic skeletal hyperostosis, severe neurologic or vascular disease.
- Subject has active (redness, swelling, fever, etc.) gout or pseudo-gout within 6 months prior to screening.
- Subject has Type I or Type II diabetes with peripheral neuropathies.
Show all 11Show fewer
- Subject has had trauma or surgery to the knee(s) within 1 year prior to the Enrollment Period.
- Subject has an underlying clinical condition, including previous malignancies that in the Investigator's judgment, is unstable.
- Subject has known allergy or hypersensitivity to capsicum, civamide, or capsaicin-containing products or any constituent of the cream formulation.
- Subject has a history of substance abuse within the past 12 months.
- Use of certain medications within the given restriction period prior to randomization and during the study.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
New Mexico Research and Osteoporosis Center, Inc.
Albuquerque, New Mexico, 87106
Radiant Research
Atlanta, Georgia, 30342
Radiant Research
Austin, Texas, 78705
Chesapeake Medical Research, LLC
Baltimore, Maryland, 21239
University Hospitals of Cleveland
Beachwood, Ohio, 44122
OMC Clinical Research Center
Beverly Hills, California, 90211
Innovative Clinical Trials
Birmingham, Alabama, 35205
Radiant Research
Boise, Idaho, 83704
Feinberg School of Medicine/Office of Clinical Rsrch and Trng
Chicago, Illinois, 60611
Hightop Medical Research Center
Cincinnati, Ohio, 45224
Radiant Research
Daytona Beach, Florida, 32114
University Clinical Research
DeLand, Florida, 32720
Robert W. Levin, MD
Dunedin, Florida, 34698
Physicians Pharmaceutical Study Services
Everett, Washington, 98201
Med. Investigations
Fair Oaks, California, 95628
Radiant Research
Greer, South Carolina, 29651
Physicians Research Group
Indianapolis, Indiana, 46250
Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Summit Research Solutions
Memphis, Tennessee, 38119
Arthritis Regional Research Center
Mercerville, New Jersey, 08619
Seligman Center for Advanced Therapeutics
New York, New York, 10003
University Clinical Research Inc.
Pembroke Pines, Florida, 33024
Radiant Research
Philadelphia, Pennsylvania, 19115
Arthritis and Rheumatic Diseases
Portsmouth, Virginia, 23701
Arthritis Clinic
Racine, Wisconsin, 53402
NC Arthritis and Allergy Care Center
Raleigh, North Carolina, 27609
Raleigh Medical Group, PA
Raleigh, North Carolina, 27609
Boling Clinical Trials
Rancho Cucamonga, California, 91730
Medex Healthcare Research Inc.
St Louis, Missouri, 63108
University of Arizona
Tucson, Arizona, 85724
Clinical Research Center of Reading, LLP
West Reading, Pennsylvania, 19611
Heartland Research Associates
Wichita, Kansas, 67207
Rheumatic Disease Associates, Ltd.
Willow Grove, Pennsylvania, 19090
Piedmont Medical Group
Winston-Salem, North Carolina, 27103
About this study
Official title: An Open-Label Multicenter Study Evaluating the Safety of Civamide Cream 0.075% as a Treatment in Subjects With Osteoarthritis of the Knee(s)
The purpose of this study is to evaluate the safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis (OA) of the Knee(s).
Read the detailed description
This is a 52-week open label study wherein subjects are required to apply the study drug on the knee(s) three times a day. Subjects are required to return to the clinic every 13 weeks.
Enrollment Visit (Day 1) At the End-of-Study/Final Visit, Day 84 of Study No. WL-1001-05-01 (or preferably < 30 days following this visit) subjects will be invited to enroll in this long-term open label Study WL-1001-05-04. Subjects will sign a written informed consent prior to being enrolled into the long-term open label study. If enrolled at the final visit or < 30 days after the final visit of Study No. WL-1001-05-01, the final visit physical examination and laboratory examination will serve as baseline for this study. If enrolled > 30 days after the final visit, a new physical examination and laboratory examination will be completed upon enrollment into this study. The subjects will complete an OA Pain Score and Subject Global Evaluation (SGE) for their Target Knee, the same knee designated as the Target Knee in Study No. WL-1001-05-01. A 13-week supply of study drug and subject diaries for the next 13 weeks will be dispensed to each subject. Instructions on how to apply the study drug will be reviewed with the subjects. Subjects will also be instructed to complete their diaries daily (Adverse Events Log and Other Medications Log) and to return their completed diaries and study drug tubes at each clinic visit.
Treatment Period (Days 1- 365) Subjects will apply study drug to their Target Knee three times a day for 52 weeks. If the subject's other knee is affected by osteoarthritis pain, it may be treated with the study drug as well. The study drug tubes will be weighed prior to being dispensed to the subject. Each tube will also be weighed when the subject returns them.
At each clinic visit, the study staff will review the diaries with each subject for completeness and legibility.
Subjects will complete the OA Pain Score and Subject Global Evaluation at clinic visits on Day 1 and Weeks 13, 26, 39, and 52. Concurrent medications, adverse events, and study drug compliance will be reviewed and recorded by the study staff throughout the Treatment Period at clinic visits on Weeks 13, 26, 39, and 52 (End-of-Study/Final Visit). At the week 52 visit (End-of-Study/Final Visit), a physical examination and laboratory examination will be performed.
On Day 365 (End-of-Study/Final Visit) the subject will be discharged after all procedures have been completed.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Civamide
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CivamideDrug
Cream 0.075%, TID for 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2004 (estimated)
- Study startNov 2003
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winston Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scott B. Phillips, M.D., Study director, Winston Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077935
- Sponsor's protocol ID
- WL-1001-05-04
- Status last verified
- Feb 2004
- First submitted
- 13 Feb 2004
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Multicenter Study Evaluating the Safety of Civamide Cream 0.075% as a Treatment in Subjects With Osteoarthritis of the Knee(s)
- ClinicalTrials.gov ID
- NCT00077935
- Acronym / sponsor ID
- WL-1001-05-04
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Winston LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 18 Feb 2004 (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.
The purpose of this study is to evaluate the safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis (OA) of the Knee(s).
Detailed description
This is a 52-week open label study wherein subjects are required to apply the study drug on the knee(s) three times a day. Subjects are required to return to the clinic every 13 weeks.
Enrollment Visit (Day 1) At the End-of-Study/Final Visit, Day 84 of Study No. WL-1001-05-01 (or preferably < 30 days following this visit) subjects will be invited to enroll in this long-term open label Study WL-1001-05-04. Subjects will sign a written informed consent prior to being enrolled into the long-term open label study. If enrolled at the final visit or < 30 days after the final visit of Study No. WL-1001-05-01, the final visit physical examination and laboratory examination will serve as baseline for this study. If enrolled > 30 days after the final visit, a new physical examination and laboratory examination will be completed upon enrollment into this study. The subjects will complete an OA Pain Score and Subject Global Evaluation (SGE) for their Target Knee, the same knee designated as the Target Knee in Study No. WL-1001-05-01. A 13-week supply of study drug and subject diaries for the next 13 weeks will be dispensed to each subject. Instructions on how to apply the study drug will be reviewed with the subjects. Subjects will also be instructed to complete their diaries daily (Adverse Events Log and Other Medications Log) and to return their completed diaries and study drug tubes at each clinic visit.
Treatment Period (Days 1- 365) Subjects will apply study drug to their Target Knee three times a day for 52 weeks. If the subject's other knee is affected by osteoarthritis pain, it may be treated with the study drug as well. The study drug tubes will be weighed prior to being dispensed to the subject. Each tube will also be weighed when the subject returns them.
At each clinic visit, the study staff will review the diaries with each subject for completeness and legibility.
Subjects will complete the OA Pain Score and Subject Global Evaluation at clinic visits on Day 1 and Weeks 13, 26, 39, and 52. Concurrent medications, adverse events, and study drug compliance will be reviewed and recorded by the study staff throughout the Treatment Period at clinic visits on Weeks 13, 26, 39, and 52 (End-of-Study/Final Visit). At the week 52 visit (End-of-Study/Final Visit), a physical examination and laboratory examination will be performed.
On Day 365 (End-of-Study/Final Visit) the subject will be discharged after all procedures have been completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent.
- Subject has participated (and not withdrawn secondary to any adverse event) in the Phase 3 Osteoarthritis Study WL-1001-05-01 and completed End-of-Study/Final Visit preferably < 30 days prior to Day 1 of this study (WL-1001-05-04).
- Subject is between 40 and 76 years of age.
- Subject is generally in good health.
- Subject is expected to be compliant with study procedures.
Key exclusion criteria (11 listed)
- Presence of tendonitis, bursitis, partial or complete joint replacement of knee(s).
- Presence of active skin disease, erythema, infection, wound, or irritation near the treatment area of the knee(s).
- Subject has an anticipated need for any surgical or other invasive procedure (e.g., synovial fluid aspiration, arthroscopy, tidal joint irrigation, injectable medications) that will be performed on the knees during the course of the study.
- Subject has a history and/or diagnosis of rheumatoid arthritis, fibromyalgia, connective tissue disease, psoriatic arthritis, erosive inflammatory OA, diffuse idiopathic skeletal hyperostosis, severe neurologic or vascular disease.
- Subject has active (redness, swelling, fever, etc.) gout or pseudo-gout within 6 months prior to screening.
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 |
|---|---|---|
| CivamideCream 0.075%, TID for 52 weeks | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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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.
Scott B. Phillips, M.D. study director
Winston Laboratories
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Civamide in people with Osteoarthritis, Knee, run by Winston Laboratories at 34 sites in United States.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 8 Jun 2011.