Parkinson's DiseasePhase 1NCT02230904
A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease
A Phase 1 study testing Rotigotine (Test product PR 2.3.1) and Rotigotine (Reference product PR 2.1.1) in people with Parkinson's Disease, run by UCB BIOSCIENCES GmbH at 11 sites in Germany.
Trial summary
The primary objective of the study is to compare the adhesiveness of 2 different patch formulations of Rotigotine using the largest patch size of 40 cm^2, under the assumption that both patch formulations show similar adhesiveness properties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Rotigotine (Test product PR 2.3.1) and Rotigotine (Reference product PR 2.1.1)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 11 sitesGermany
- Study dates
- Sep 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a diagnosis of idiopathic Parkinson's Disease
- Subject has been on continuous treatment with commercially available Rotigotine transdermal patches (Neupro®) for at least 3 months prior to enrollment
- Subject has been taking a stable Rotigotine dose including an 8 mg/24 hours (40 cm^2) patch for at least 2 weeks prior to enrollment
Who cannot join
- Subject has any medical or psychiatric condition which, in the opinion of the investigator, could jeopardize or would compromise the subject's well-being or ability to participate in this study
- Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recently unsolved contact dermatitis
- Subject has a history or present condition of an atopic or eczematous Dermatitis, Psoriasis, or an active skin disease
- Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1) or Baseline (Visit 2)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
104
Alzenau in Unterfranken
106
Aschaffenburg
105
Berlin
107
Böblingen
101
Cologne
111
Düsseldorf
109
Erbach im Odenwald
110
Essen
102
Karlstadt am Main
103
Stuttgart
108
Würzburg
About this study
Official title: A Multicenter, Randomized, Double-blind, 2-way Cross-over Study to Compare the Adhesiveness of 2 Different Rotigotine Patch Formulations in Subjects With Parkinson's Disease
The primary objective of the study is to compare the adhesiveness of 2 different patch formulations of Rotigotine using the largest patch size of 40 cm^2, under the assumption that both patch formulations show similar adhesiveness properties.
- Conditions
- Parkinson's Disease
- Being tested
- Rotigotine (Test product PR 2.3.1), Rotigotine (Reference product PR 2.1.1)
- Keywords
- Rotigotine patch, Neupro, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotigotine (Test product PR 2.3.1)Drug
- Pharmaceutical form: Transdermal patch
- Concentration: 8 mg/24 hours
- Route of administration: Transdermal
Rotigotine (Reference product PR 2.1.1)Drug
Also called Neupro
- Pharmaceutical form: Transdermal patch
- Concentration: 8 mg/24 hours
- Route of administration: Transdermal
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A-B | Experimental | 4 day treatment (Treatment A: Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B: Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1) Receives: Drug: Rotigotine (Test product PR 2.3.1); Drug: Rotigotine (Reference product PR 2.1.1) |
| Treatment Arm B-A | Experimental | 4 day treatment (Treatment B: Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A: Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1) Receives: Drug: Rotigotine (Test product PR 2.3.1); Drug: Rotigotine (Reference product PR 2.1.1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average Adhesiveness Score of 2 Days of 24 Hours Patch Application as Rated by the Investigator (or Designee) Assessed According to the EMA Draft Guideline
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).
- 0 = > 95 - 100 % of the patch area adheres
- 1 = > 90 - 95 % of the patch adheres
- 2 = > 85 - 90 % of the patch adheres
- 3 = > 80 - 85 % of the patch adheres
- 4 = > 75 - 80 % of the patch adheres
- 5 = > 70 - 75 % of the patch adheres
- 6 = ≥ 50 - 70 % of the patch adheres
- 7 = < 50 % of the patch adheres
- 8 = Patch completely detached
The recorded scores 6, 7, and 8 were combined in order to create a cumulative group "less than or equal to 70 % adhered or patch detachment" which was regarded as significant patch adhesion failure in the draft EMA guideline.
The average of patches 1 and 2 is presented by Treatment Arm below.
Measured: Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5
Secondary outcomes (7)
Patch Adhesiveness Per Day as Rated by the Investigator or Designee 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 1
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).
- 0 = >95 - 100 % of the patch area adheres
- 1 = >90 - 95 % of the patch adheres
- 2 = >85 - 90 % of the patch adheres
- 3 = >80 - 85 % of the patch adheres
- 4 = >75 - 80 % of the patch adheres
- 5 = >70 - 75 % of the patch adheres
- 6 = ≥50 - 70 % of the patch adheres
- 7 = <50 % of the patch adheres
- 8 = Patch completely detached
The recorded scores 6, 7, and 8 were combined in order to create a cumulative group "less than or equal to 70 % adhered or patch detachment" which was regarded as significant patch adhesion failure in the draft EMA guideline.
Measured: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).
- 0 = >95 - 100 % of the patch area adheres
- 1 = >90 - 95 % of the patch adheres
- 2 = >85 - 90 % of the patch adheres
- 3 = >80 - 85 % of the patch adheres
- 4 = >75 - 80 % of the patch adheres
- 5 = >70 - 75 % of the patch adheres
- 6 = ≥50 - 70 % of the patch adheres
- 7 = <50 % of the patch adheres
- 8 = Patch completely detached
The recorded scores 6, 7, and 8 were combined in order to create a cumulative group "less than or equal to 70 % adhered or patch detachment" which was regarded as significant patch adhesion failure in the draft EMA guideline.
Measured: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 1
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:
- 0 (>95-100% of patch adheres) >> 0 (FDA/CDER)
- 1 (>90-95% of patch adheres) >> 0 (FDA/CDER)
- 2 (>85-90% of patch adheres) >> 1 (FDA/CDER)
- 3 (>80-85% of patch adheres) >> 1 (FDA/CDER)
- 4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)
- 5 (>70-75% of patch adheres) >> 2 (FDA/CDER)
- 6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)
- 7 (<50 % of patch adheres) >> 3 (FDA/CDER)
- 8 (Patch completely detached) >> 4 (FDA/CDER)
Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies.
Measured: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 2
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:
- 0 (>95-100% of patch adheres) >> 0 (FDA/CDER)
- 1 (>90-95% of patch adheres) >> 0 (FDA/CDER)
- 2 (>85-90% of patch adheres) >> 1 (FDA/CDER)
- 3 (>80-85% of patch adheres) >> 1 (FDA/CDER)
- 4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)
- 5 (>70-75% of patch adheres) >> 2 (FDA/CDER)
- 6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)
- 7 (<50 % of patch adheres) >> 3 (FDA/CDER)
- 8 (Patch completely detached) >> 4 (FDA/CDER)
Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies.
Measured: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5
Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1
The subject assessed the patch adhesiveness by using the following score:
- 0 = Satisfied with adhesiveness
- 1 = Moderately satisfied with adhesiveness
- 2 = Moderately unsatisfied with adhesiveness
- 3 = Unsatisfied with adhesiveness
Measured: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4
Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2
The subject assessed the patch adhesiveness by using the following score:
- 0 = Satisfied with adhesiveness
- 1 = Moderately satisfied with adhesiveness
- 2 = Moderately unsatisfied with adhesiveness
- 3 = Unsatisfied with adhesiveness
Measured: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5
Change in Average Patch Adhesiveness Score of 2 Days of 24 Hour Patch Application as Rated by the Investigator (or Designee), Assessed According to the FDA/Center for Drug Evaluation and Research (CDER) Score
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:
- 0 (>95-100% of patch adheres) >> 0 (FDA/CDER)
- 1 (>90-95% of patch adheres) >> 0 (FDA/CDER)
- 2 (>85-90% of patch adheres) >> 1 (FDA/CDER)
- 3 (>80-85% of patch adheres) >> 1 (FDA/CDER)
- 4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)
- 5 (>70-75% of patch adheres) >> 2 (FDA/CDER)
- 6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)
- 7 (<50 % of patch adheres) >> 3 (FDA/CDER)
- 8 (Patch completely detached) >> 4 (FDA/CDER)
Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies.
Measured: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Health Sciences, Bracket Global
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230904
- Sponsor's protocol ID
- PD0018
- Other IDs
- 2014-000932-41, 2014
- Status last verified
- Oct 2015
- First submitted
- 29 Aug 2014
- Last updated
- 2 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Elshoff JP, Bauer L, Goldammer N, Oortgiesen M, Pesch H, Timmermann L. Randomized, double-blind, crossover study of the adhesiveness of two formulations of rotigotine transdermal patch in patients with Parkinson's disease. Curr Med Res Opin. 2018 Jul;34(7):1293-1299. doi: 10.1080/03007995.2018.1430559. Epub 2018 Feb 20.
PubMed 29461870
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, 2-way Cross-over Study to Compare the Adhesiveness of 2 Different Rotigotine Patch Formulations in Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02230904
- Acronym / sponsor ID
- PD0018
- Conditions
- Parkinson's Disease
- Keywords
- Rotigotine patch, Neupro, Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Health Sciences, Bracket Global
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Posted 2 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to compare the adhesiveness of 2 different patch formulations of Rotigotine using the largest patch size of 40 cm^2, under the assumption that both patch formulations show similar adhesiveness properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm A-B | Experimental | Drug: Rotigotine (Test product PR 2.3.1), Drug: Rotigotine (Reference product PR 2.1.1)4 day treatment (Treatment A: Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B: Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1) |
| Treatment Arm B-A | Experimental | Drug: Rotigotine (Test product PR 2.3.1), Drug: Rotigotine (Reference product PR 2.1.1)4 day treatment (Treatment B: Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A: Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has a diagnosis of idiopathic Parkinson's Disease
- Subject has been on continuous treatment with commercially available Rotigotine transdermal patches (Neupro®) for at least 3 months prior to enrollment
- Subject has been taking a stable Rotigotine dose including an 8 mg/24 hours (40 cm^2) patch for at least 2 weeks prior to enrollment
Key exclusion criteria (4 listed)
- Subject has any medical or psychiatric condition which, in the opinion of the investigator, could jeopardize or would compromise the subject's well-being or ability to participate in this study
- Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recently unsolved contact dermatitis
- Subject has a history or present condition of an atopic or eczematous Dermatitis, Psoriasis, or an active skin disease
- Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1) or Baseline (Visit 2)
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 |
|---|---|---|
| Rotigotine (Test product PR 2.3.1)* Pharmaceutical form: Transdermal patch * Concentration: 8 mg/24 hours * Route of administration: Transdermal | Drug | Treatment Arm A-B, Treatment Arm B-A |
| Rotigotine (Reference product PR 2.1.1)Also: Neupro* Pharmaceutical form: Transdermal patch * Concentration: 8 mg/24 hours * Route of administration: Transdermal | Drug | Treatment Arm A-B, Treatment Arm B-A |
Primary outcome
Change in Average Adhesiveness Score of 2 Days of 24 Hours Patch Application as Rated by the Investigator (or Designee) Assessed According to the EMA Draft Guideline
Time frame: Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012). * 0 = > 95 - 100 % of the patch area adheres * 1 = > 90 - 95 % of the patch adheres * 2 = > 85 - 90 % of the patch adheres * 3 = > 80 - 85 % of the patch adheres * 4 = > 75 - 80 % of the patch adheres * 5 = > 70 - 75 % of the patch adheres * 6 = ≥ 50 - 70 % of the patch adheres * 7 = < 50 % of the patch adheres * 8 = Patch completely detached The recorded scores 6, 7, and 8 were combined in order to create a cumulative group "less than or equal to 70 % adhered or patch detachment" which was regarded as significant patch adhesion failure in the draft EMA guideline. The average of patches 1 and 2 is presented by Treatment Arm below.
7 secondary outcomes
Patch Adhesiveness Per Day as Rated by the Investigator or Designee 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 1
Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2
Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 1
Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 2
Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5
Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1
Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4
Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2
Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5
Change in Average Patch Adhesiveness Score of 2 Days of 24 Hour Patch Application as Rated by the Investigator (or Designee), Assessed According to the FDA/Center for Drug Evaluation and Research (CDER) Score
Time frame: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29461870Elshoff JP, Bauer L, Goldammer N, Oortgiesen M, Pesch H, Timmermann L. Randomized, double-blind, crossover study of the adhesiveness of two formulations of rotigotine transdermal patch in patients with Parkinson's disease. Curr Med Res Opin. 2018 Jul;34(7):1293-1299. doi: 10.1080/03007995.2018.1430559. Epub 2018 Feb 20.
- Product InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
UCB Clinical Trial Call Center study director
UCB Pharma
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rotigotine (Test product PR 2.3.1) and Rotigotine (Reference product PR 2.1.1) in people with Parkinson's Disease, run by UCB BIOSCIENCES GmbH at 11 sites in Germany.
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 4 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 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. 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?
Yes. Results are posted in the registry (first posted 2 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Average Adhesiveness Score of 2 Days of 24 Hours Patch Application as Rated by the Investigator (or Designee) Assessed According to the EMA Draft Guideline (time frame: Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02230904, which also lists 1 linked publication.
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 2 Nov 2015.