Parkinson DiseasePhase 2NCT00460148
Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole
A Phase 2 study testing Ropinirole in people with Parkinson Disease, run by GlaxoSmithKline at 2 sites in 2 countries.
Trial summary
This study in PD patients is designed to assess the affect food has on the absorption, distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted state and other patients following a high-fat breakfast), and to assess the difference in absorption, distribution, metabolism and excretion… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Ropinirole
- How many people
- 28 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2007to Aug 2007
- Phase
- Phase 2
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged between 30 and 85 years of age
- Body mass index of 18 to 32 kg/m2, body weight of at least 50 kg.
- Diagnosis of idiopathic Parkinson's disease
- Patients must have provided written informed consent prior to performing any study procedures
- QTc interval of < 450ms (or QTc < 480ms in patients with Bundle Branch Block).
Who cannot join
- Patients who have an abnormality on physical examination.
- Patients who have medical conditions which could present a safety concern.
- Patients who have a clinically significant abnormal laboratory value, ECG, or physical examination finding
- Positive result for Hepatitis B surface antigen, Hepatitis C antibody or Human Immunodeficiency Virus (HIV) antibody
- Positive alcohol test result and / or urine test for undeclared drugs
- Recent history of moderate to severe dizziness, syncope, or orthostatic hypotension
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- Significant sleep disorder or Epworth Sleep Score (Appendix 5) > 9
- Patients with a lying/sitting diastolic blood pressure =110mmHg or =50mmHg or a systolic blood pressure =180mmHg or =90mmHg
- History of any dopaminergic treatment (other than ropinirole IR and L-dopa) within 2 weeks prior to first dose.
- Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 or induce CYP1A2
- Patients who smoke >20 cigarettes per day and will not maintain a constant smoking habit for the duration of the study.
- Blood donation or significant blood loss less than 90 days before Day 1 of the current study.
- Definite or suspected personal history, or family history, of adverse reactions or hypersensitivity to ropinirole or to drugs with a similar chemical structure.
- Use of any investigational drug (with the exception of ropinirole PR/CR) within 30 days or 5 half lives (whichever is longer) before the start of dosing with study medication.
- Patients who have received over-the-counter (OTC) medicine within 48 h before the first dose of study drug.
- Recent history, or suspicion, of drug dependence or abuse of alcohol
- Significant concern, or likelihood, that the patient will drop out of the study prematurely, will require new or prohibited concomitant medications during the study period, or will not be compliant with study procedures.
- Women who are pregnant or breast-feeding.
- Female patient is currently either of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or any female who is surgically sterilized (via documented hysterectomy or bilateral tubal ligation).
- (For purposes of this study, postmenopausal is defined as one year without menses) OR
- child-bearing potential, has a negative urine/serum pregnancy test at the Screening Visit (prior to investigational product administration), and agrees to use acceptable contraception from one month prior to study Day 1 until one month after completion of the study (ie. one month after the follow-up visit). All hormonal birth control must have been administered for at least one monthly cycle prior to the Screening Visit. GSK acceptable contraception methods, when used consistently and in accordance with both the product label and the instructions of a physician, are as follows:
- complete abstinence
- sterilization of patient's male partner prior to female patient's entry into study
- oral contraceptive (either combined or progestogen only)
- any intra-uterine device with a documented failure rate of less than 1% per year
- systemic contraception (eg. norplant system)
- double barrier method if comprised of a spermicide with either a condom or diaphragm
- Patients with prior or current major psychosis
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets.
This study in PD patients is designed to assess the affect food has on the absorption, distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted state and other patients following a high-fat breakfast), and to assess the difference in absorption, distribution, metabolism and excretion of ropinirole if patients are given three 4mg ropinirole tablets versus one 12mg tablet.
- Conditions
- Parkinson Disease
- Being tested
- Ropinirole
- Keywords
- ropinirole PR/CR,, pharmacokinetic,, formulation,, food effect,, SK&F101468,, PD
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopiniroleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Ropinirole AUC, the area under the plasma concentration-time curve over 24 hours Ropinirole maximum plasma concentration over 24 hours
Measured: 24 hours
Secondary outcomes (2)
Time to attain the maximum plasma concentration Incidence of adverse events over 37 days As above, but for ropinirole metabolites
Measured: over 37 days
Vital signs, ECG and clinical laboratory data over 37 days
Measured: over 37 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startApr 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460148
- Sponsor's protocol ID
- ROP109087
- Status last verified
- Oct 2016
- First submitted
- 11 Apr 2007
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
This study has not been published in the scientific literature.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets.
- ClinicalTrials.gov ID
- NCT00460148
- Acronym / sponsor ID
- ROP109087
- Conditions
- Parkinson Disease
- Keywords
- ropinirole PR/CR,, pharmacokinetic,, formulation,, food effect,, SK&F101468,, PD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Study completion
- Aug 2007 (actual)
- First posted
- 13 Apr 2007 (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.
This study in PD patients is designed to assess the affect food has on the absorption, distribution, metabolism and excretion of ropinirole (by dosing some patients in the fasted state and other patients following a high-fat breakfast), and to assess the difference in absorption, distribution, metabolism and excretion of ropinirole if patients are given three 4mg ropinirole tablets versus one 12mg tablet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients aged between 30 and 85 years of age
- Body mass index of 18 to 32 kg/m2, body weight of at least 50 kg.
- Diagnosis of idiopathic Parkinson's disease
- Patients must have provided written informed consent prior to performing any study procedures
- QTc interval of < 450ms (or QTc < 480ms in patients with Bundle Branch Block).
Key exclusion criteria (29 listed)
- Patients who have an abnormality on physical examination.
- Patients who have medical conditions which could present a safety concern.
- Patients who have a clinically significant abnormal laboratory value, ECG, or physical examination finding
- Positive result for Hepatitis B surface antigen, Hepatitis C antibody or Human Immunodeficiency Virus (HIV) antibody
- Positive alcohol test result and / or urine test for undeclared drugs
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 |
|---|---|---|
| Ropinirole | Drug | – |
Primary outcome
Ropinirole AUC, the area under the plasma concentration-time curve over 24 hours Ropinirole maximum plasma concentration over 24 hours
Time frame: 24 hours
2 secondary outcomes
Time to attain the maximum plasma concentration Incidence of adverse events over 37 days As above, but for ropinirole metabolites
Time frame: over 37 days
Vital signs, ECG and clinical laboratory data over 37 days
Time frame: over 37 days
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 28 Oct 2016.
- BackgroundThis study has not been published in the scientific literature.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ropinirole in people with Parkinson Disease, run by GlaxoSmithKline at 2 sites in 2 countries.
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 5 inclusion and 29 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 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, South Africa. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Ropinirole AUC, the area under the plasma concentration-time curve over 24 hours Ropinirole maximum plasma concentration over 24 hours (time frame: 24 hours). 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 NCT00460148, 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 28 Oct 2016.