Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations

NCT ID: NCT01338896

Last Updated: 2011-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of the study is to compare the adhesiveness of two different patch formulations of rotigotine using patch size 40 cm2, under the assumption that both patch formulations show similar adhesiveness properties.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sequence A-B

4 day treatment (Treatment A: Rotigotine transdermal patch 8 mg/24 h, test product PR 2.2.1 followed by Treatment B: Rotigotine transdermal patch 8 mg/24 h reference patch PR 2.1.1)

Group Type EXPERIMENTAL

Rotigotine transdermal patch

Intervention Type DRUG

8 mg/24 h, transdermal patch 8 mg/24 h, 2 days

Sequence B-A

4 day treatment (Treatment B: Rotigotine transdermal patch 8 mg/24 h reference patch PR 2.1.1 followed by Treatment A: Rotigotine transdermal patch 8 mg/24 h, test product PR 2.2.1)

Group Type EXPERIMENTAL

Rotigotine transdermal patch

Intervention Type DRUG

8 mg/24 h, transdermal patch 8 mg/24 h, 2 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rotigotine transdermal patch

8 mg/24 h, transdermal patch 8 mg/24 h, 2 days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Neupro

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects with a diagnosis of idiopathic Parkinson´s disease, and continuous treatment with commercially available rotigotine transdermal patch for at least 3 months, and a stable rotigotine dose including an 8 mg/24 h patch for at least 2 weeks prior to enrollment

Exclusion Criteria

* Subjects has previously participated in this study, failed to be screened, or has participated in another study with an investigational medicinal product (IMP) or medical device within the last 30 days or is currently participating in such
* Subject with a history of significant skin hypersensitivity to adhesives, other transdermal products or recently unsolved contact dermatitis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Innsbruck, , Austria

Site Status

Vienna, , Austria

Site Status

Alzenau in Unterfranken, , Germany

Site Status

Berlin, , Germany

Site Status

Bochum, , Germany

Site Status

Böblingen, , Germany

Site Status

Cologne, , Germany

Site Status

Gera, , Germany

Site Status

Karlstadt am Main, , Germany

Site Status

Stuttgart, , Germany

Site Status

Wolfach, , Germany

Site Status

Blackpool, , United Kingdom

Site Status

Derby, , United Kingdom

Site Status

Liverpool, , United Kingdom

Site Status

Newcastle upon Tyne, , United Kingdom

Site Status

Norwich, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria Germany United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Elshoff JP, Timmermann L, Schmid M, Arth C, Komenda M, Brunnert M, Bauer L. Comparison of the bioavailability and adhesiveness of different rotigotine transdermal patch formulations. Curr Med Res Opin. 2013 Dec;29(12):1657-62. doi: 10.1185/03007995.2013.841666. Epub 2013 Sep 23.

Reference Type DERIVED
PMID: 24006953 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010-024250-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP1066

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.