Last updated: 07/13/2020 13:50:05
Restless Legs Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole And The Effect Of Food
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An open label, repeat dose, dose escalation study conducted in RLS patients to characterize pharmacokinetics and food effect of ropinirole controlled release for RLS
Trial description: This study in RLS 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 two 3mg ropinirole tablets versus one 6mg tablet.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Ropinirole AUC (area under the plasma concentration-time curve) over the dosing interval Ropinirole maximum plasma concentration
Timeframe: dosing interval
Secondary outcomes:
Time to attain the maximum plasma concentration Time taken for ropinirole concentration to fall to half initial value Incidence of adverse events Vital signs, ECG and clinical laboratory data As above, but for ropinirole metabolites
Timeframe: Time taken for ropinirole concentration to fall to half initial value
Interventions:
Drug: Ropinirole
Enrollment:
32
Observational study model:
Not applicable
Primary completion date:
2006-12-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Restless Legs Syndrome
Product
ropinirole
Collaborators
Not applicable
Study date(s)
August 2006 to December 2006
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Patients with a diagnosis of RLS
- Body mass index of 18 to 32 kg/m², with a body weight of at least 50 kg
- History of postural hypotension or faints
- Secondary RLS
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with a diagnosis of RLS
- Body mass index of 18 to 32 kg/m², with a body weight of at least 50 kg
- Normal blood pressure pre-study
- Light smokers only (<20/day)
Exclusion criteria:
- History of postural hypotension or faints
- Secondary RLS
- Patients who suffer from a primary sleep disorder other than RLS
- Patients diagnosed with movement disorders
- Patients with unstable medical conditions
- Patients with personal or family history of adverse reactions or hypersensitivity to the study drug
- Patients with abnormal laboratory values
- Patients with hepatitis or HIV
- Patients who abuse alcohol or drugs
- Patients taking the following medications: dopamine agonists (including ropinirole), dopamine antagonists (e.g., metoclopramide and domperidone), levodopa/carbidopa
Trial location(s)
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2006-12-12
Actual study completion date
2006-12-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study ROR106470 can be found on the GSK Clinical Study Register.
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