Trial · NCT07015346
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The cumulative mean percentage adhesion of the transdermal patch over the 24-hour dosing interval for two treatment periods, compared between Rotigexole (Test) and Neupro® (Reference) | two treatment periods (4 days) | Using a mixed-effects model adjusted for period and sequence effects, with subject as a random effect |
| Secondary | Proportion of participants achieving more than 90% adherence at 4, 8, 12 and 24 hours at each period as assessed by the investigator/designee as per modified EMA scale for adhesion. | two treatment periods (4 days) | |
| Secondary | Adjusted Mean adherence percentage at each assessment time (4, 8, 12 and 24 hours). | two treatment periods (4 days) | |
| Secondary | Proportion of participants with a meaningful degree of detachment (more than half of the patch lifting off the skin or falling off) at 4, 8, 12 and 24 hours. | two treatment periods (4 days) | |
| Secondary | Number of patches that are completely detached at 4, 8, 12 and 24 hours. | two treatment periods (4 days) | |
| Secondary | Number of participants with cold flow in each treatment period (Cold flow is defined as dark ring formed around the patch). | two treatment periods (4 days) | |
| Secondary | Number of participants with patch movement/displacement in each treatment period. | two treatment periods (4 days) | |
| Secondary | Number of participants with patch wrinkling in each treatment period. | two treatment periods (4 days) | |
| Secondary | Number of participants with patch residue formation in each treatment period (Patch residue formation is assessed at patch application on the release liner and at patch removal on the skin). | two treatment periods (4 days) | |
| Secondary | % of patients reporting ease or difficulty in patch application and removal. | two treatment periods (4 days) | |
| Secondary | Frequency of Adhesion-Related Issues: Evaluate the frequency of adhesion-related issues (e.g., patch detachment). | two treatment periods (4 days) | |
| Secondary | % of patients with reported interference in daily activities due to patch adhesion. | two treatment periods (4 days) | |
| Secondary | % of patients reporting overall satisfaction with wearing each patch type, measured using a Patch Wear Satisfaction Scale. | two treatment periods (4 days) | |
| Secondary | The incidence, seriousness and severity of adverse events (AEs) including application site reactions, and discontinuations because of AEs | two treatment periods (4 days) |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07015346/registered