Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528
NCT ID: NCT01536574
Last Updated: 2018-08-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
295 participants
INTERVENTIONAL
2010-09-02
2012-03-28
Brief Summary
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Subjects must not have a break in study medication between completing the feeder study and entering extension study, treatment must be continuous.
Subjects will be dispensed down-titration medication at the study completion/early withdrawal visit and should be scheduled to return for a follow up visit 4 to 14 days after the last dose of study medication.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Requip PR
Ropinirole PR tablets of 2.0 mg, 4.0mg and 8.0 mg
Requip PR
Eligible patients will be dispensed medication to uptitrate their REQUIP PR dose (2, 4, 6, 8mg respectively) during the first 4 weeks of treatment. During the 24 week treatment phase, the subjects dose will be adjusted according to the recommended schedule to achieve symptomatic control.
Interventions
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Requip PR
Eligible patients will be dispensed medication to uptitrate their REQUIP PR dose (2, 4, 6, 8mg respectively) during the first 4 weeks of treatment. During the 24 week treatment phase, the subjects dose will be adjusted according to the recommended schedule to achieve symptomatic control.
Eligibility Criteria
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Inclusion Criteria
2. Subjects must not have a break in medication between completing the downtitration phase for studies ROP111528 and beginning treatment in this extension study.
3. Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for one month following completion of the study. Acceptable contraceptive methods include oral contraception, surgical sterilization, intrauterine device (IUD), or diaphragm IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception (e.g. Norplant System).
4. Provide written informed consent for this study.
5. Be willing and able to comply with study procedures.
Exclusion Criteria
2. Subjects with severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the investigator, would render the subject unsuitable for the study (e.g., psychiatric, hematological, renal, hepatic, endocrinology, neurological (other than Parkinson's disease), cardiovascular, or active malignancy (other than basal cell carcinoma).
3. Subjects with clinically significant abnormalities in Laboratory or ECG tests at the end of the study ROP111528.
4. Subjects with severe dizziness or fainting due to postural hypotension on standing.
5. Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrolment through the end of the treatment period.
6. Women who are pregnant or breast-feeding.
7. Use of an investigational drug throughout the treatment period.
30 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Guangzhou, Guangdong, China
GSK Investigational Site
Wuhan, Hubei, China
GSK Investigational Site
Suzhou, Jiangsu, China
GSK Investigational Site
Xi'an, Shaanxi, China
GSK Investigational Site
Chengdu, Sichuan, China
GSK Investigational Site
Chengdu, Sichuan, China
GSK Investigational Site
Kunming, Yunnan, China
GSK Investigational Site
Kunming, Yunnan, China
GSK Investigational Site
Hangzhou, Zhejiang, China
GSK Investigational Site
Beijing, , China
GSK Investigational Site
Beijing, , China
GSK Investigational Site
Beijing, , China
GSK Investigational Site
Beijing, , China
GSK Investigational Site
Beijing, , China
GSK Investigational Site
Shanghai, , China
GSK Investigational Site
Shanghai, , China
GSK Investigational Site
Shanghai, , China
GSK Investigational Site
Tianjin, , China
Countries
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References
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Zhang Z, Wang J, Zhang X, Chen S, Wang Z, Zhang B, Liu C, Qu Q, Cheng Y, Zhu R, Li J, Hu J, Cai M. An open-label extension study to evaluate the safety of ropinirole prolonged release in Chinese patients with advanced Parkinson's disease. Curr Med Res Opin. 2015 Apr;31(4):723-30. doi: 10.1185/03007995.2015.1005835. Epub 2015 Mar 12.
Other Identifiers
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114463
Identifier Type: -
Identifier Source: org_study_id
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