Osteoarthritis of the KneePhase 1NCT04882319
Irritation and Sensitization Study of HP-5000 Topical System
A Phase 1 study testing HP-5000 Topical Patch and Saline Patch in people with Osteoarthritis of the Knee, run by Noven Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study will assess skin irritation and sensitization for HP-5000 patch in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- HP-5000 Topical Patch and Saline Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2021to 11 Mar 2022
- Phase
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject provides written informed consent prior to entering the study or undergoing any study procedures;
- Subject is a generally healthy male or female 18 to 65 years of age;
- Subject is considered to be healthy on the basis of medical history, physical examination, vital signs, normal electrocardiogram (ECG) and clinical laboratory test results.
Who cannot join
- Subject is pregnant or lactating, or females planning a pregnancy during the course of the trial;
- Subject has severe cardiac, renal or hepatic impairment;
- Subject has used any topical drugs at the patch application site within 72 hours prior to dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluator-blinded, Randomized Within-subject Repeat Insult Study to Evaluate Potential Skin Irritation and Sensitization of HP-5000 (Diclofenac Sodium Topical System) in Healthy Adults
This study will assess skin irritation and sensitization for HP-5000 patch in healthy subjects.
Read the detailed description
This is an evaluator-blinded, randomized phase 1 study evaluating skin irritation and sensitization of HP-5000 topical system in comparison to control patches. The study will consist of a 4-week Screening Phase and a Treatment Phase. The Treatment Phase will consist of the following periods: an Induction Period, a Rest Period followed by a Challenge Period and if needed, a Re-Challenge Period.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- HP-5000 Topical Patch, HP-5000 Placebo Patch, Saline Patch
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP-5000 Topical PatchDrug
Also called HP-5000 Patch
HP-5000, placebo and saline will be administered simultaneously
HP-5000 Placebo PatchDrug
Also called Placebo Control
HP-5000, placebo and saline will be administered simultaneously
Saline PatchDrug
Also called Saline Control
HP-5000, placebo and saline will be administered simultaneously
| Study group | Role | What they receive |
|---|---|---|
| HP-5000 Topical Patch | Experimental | HP-5000, placebo and saline will be administered simultaneously. Receives: Drug: HP-5000 Topical Patch; Drug: HP-5000 Placebo Patch; Drug: Saline Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating skin irritation with Mean Irritation Score (MIS)
To evaluate skin irritation after exposure to HP-5000, placebo and saline.
Measured: 21 days
Evaluating skin sensitization with the number and proportion of subjects sensitized using descriptive statistics
To evaluate skin sensitization after exposure to HP-5000, placebo and saline.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start3 Jun 2021
- Primary completion8 Mar 2022
- Study completion11 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noven Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Noven Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882319
- Sponsor's protocol ID
- HP-5000-US-06
- Status last verified
- Aug 2022
- First submitted
- 3 May 2021
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluator-blinded, Randomized Within-subject Repeat Insult Study to Evaluate Potential Skin Irritation and Sensitization of HP-5000 (Diclofenac Sodium Topical System) in Healthy Adults
- ClinicalTrials.gov ID
- NCT04882319
- Acronym / sponsor ID
- HP-5000-US-06
- Conditions
- Osteoarthritis of the Knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Noven Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 11 May 2021 (actual)
- 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.
This study will assess skin irritation and sensitization for HP-5000 patch in healthy subjects.
Detailed description
This is an evaluator-blinded, randomized phase 1 study evaluating skin irritation and sensitization of HP-5000 topical system in comparison to control patches. The study will consist of a 4-week Screening Phase and a Treatment Phase. The Treatment Phase will consist of the following periods: an Induction Period, a Rest Period followed by a Challenge Period and if needed, a Re-Challenge Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HP-5000 Topical Patch | Experimental | Drug: HP-5000 Topical Patch, Drug: HP-5000 Placebo Patch, Drug: Saline PatchHP-5000, placebo and saline will be administered simultaneously. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject provides written informed consent prior to entering the study or undergoing any study procedures;
- Subject is a generally healthy male or female 18 to 65 years of age;
- Subject is considered to be healthy on the basis of medical history, physical examination, vital signs, normal electrocardiogram (ECG) and clinical laboratory test results.
Key exclusion criteria (3 listed)
- Subject is pregnant or lactating, or females planning a pregnancy during the course of the trial;
- Subject has severe cardiac, renal or hepatic impairment;
- Subject has used any topical drugs at the patch application site within 72 hours prior to dosing.
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 |
|---|---|---|
| HP-5000 Topical PatchAlso: HP-5000 PatchHP-5000, placebo and saline will be administered simultaneously | Drug | HP-5000 Topical Patch |
| HP-5000 Placebo PatchAlso: Placebo ControlHP-5000, placebo and saline will be administered simultaneously | Drug | HP-5000 Topical Patch |
| Saline PatchAlso: Saline ControlHP-5000, placebo and saline will be administered simultaneously | Drug | HP-5000 Topical Patch |
Primary outcome
Evaluating skin irritation with Mean Irritation Score (MIS)
Time frame: 21 days
To evaluate skin irritation after exposure to HP-5000, placebo and saline.
Evaluating skin sensitization with the number and proportion of subjects sensitized using descriptive statistics
Time frame: 21 days
To evaluate skin sensitization after exposure to HP-5000, placebo and saline.
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 23 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Study Director study director
Noven Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HP-5000 Topical Patch and Saline Patch in people with Osteoarthritis of the Knee, run by Noven Pharmaceuticals, Inc. at 1 site 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 3 inclusion and 3 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 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Evaluating skin irritation with Mean Irritation Score (MIS) (time frame: 21 days). The study lists 2 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 23 Aug 2022.