Trial record 8 of 1212 for:    "Parkinson Disease"

Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00460148
First received: April 11, 2007
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
Parkinson's Disease
Drug: Ropinirole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Ropinirole AUC, the area under the plasma concentration-time curve over 24 hours Ropinirole maximum plasma concentration over 24 hours [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 28
Study Start Date: April 2007
Study Completion Date: August 2007
Intervention Details:
    Drug: Ropinirole
    Other Name: Ropinirole
  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
  • 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:

    1. 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

    2. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460148

Locations
Germany
GSK Investigational Site
Berlin, Germany, 10117
South Africa
GSK Investigational Site
George, Eastern Cape, South Africa, 6529
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00460148     History of Changes
Other Study ID Numbers: ROP109087
Study First Received: April 11, 2007
Last Updated: May 31, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
South Africa: Medicines Control Council

Keywords provided by GlaxoSmithKline:
ropinirole PR/CR,
pharmacokinetic,
formulation,
food effect,
SK&F101468,
PD

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014