Trial Outcomes & Findings for Pramipexole Conversion to Ropinirole Controlled Release (CR) (NCT NCT00275275)
NCT ID: NCT00275275
Last Updated: 2012-08-24
Results Overview
Number of adverse effect experienced by participants in the different conversion ratio groups.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
61 participants
Primary outcome timeframe
Week 4
Results posted on
2012-08-24
Participant Flow
Patients were enrolled at the University of Kansas Medical Center. Enrollment started in January 2006 and ended in February 2008.
Participant milestones
| Measure |
Mirapex to Requip 24-Hour of 1:3
Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3
|
Mirapex to Requip 24-Hour of 1:4
Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4
|
Mirapex to Requip 24-Hour of 1:5
Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
21
|
|
Overall Study
COMPLETED
|
14
|
18
|
15
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pramipexole Conversion to Ropinirole Controlled Release (CR)
Baseline characteristics by cohort
| Measure |
Mirapex to Requip 24-Hour of 1:3
n=20 Participants
Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3
|
Mirapex to Requip 24-Hour of 1:4
n=20 Participants
Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4
|
Mirapex to Requip 24-Hour of 1:5
n=21 Participants
Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
64.1 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
66.2 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
64.7 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
21 participants
n=5 Participants
|
61 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 4Number of adverse effect experienced by participants in the different conversion ratio groups.
Outcome measures
| Measure |
Preferred Requip PR
n=33 Participants
This group refers to the subjects that preferred Requip PR to Mirapex
|
Preferred Mirapex
n=27 Participants
This group refers to the subjects that preferred Mirapex
|
|---|---|---|
|
Adverse Effects Experienced
|
29 number of events
|
43 number of events
|
SECONDARY outcome
Timeframe: Week 4Outcome measures the number of times a dose needed to be adjusted to compensate for adverse effects experienced.
Outcome measures
| Measure |
Preferred Requip PR
n=33 Participants
This group refers to the subjects that preferred Requip PR to Mirapex
|
Preferred Mirapex
n=27 Participants
This group refers to the subjects that preferred Mirapex
|
|---|---|---|
|
Number of Dose Adjustments
|
0.6 number of adjustments
Standard Deviation 0.7
|
1.3 number of adjustments
Standard Deviation 1.2
|
Adverse Events
Preferred Requip PR
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Preferred Mirapex
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Preferred Requip PR
n=33 participants at risk
These are the subjects that preferred Requip PR to Mirapex at the end of the study
|
Preferred Mirapex
n=27 participants at risk
These are the subjects that preferred Mirapex to Requip PR at the end of the study
|
|---|---|---|
|
General disorders
PD worsening
|
18.2%
6/33 • Number of events 6
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
29.6%
8/27 • Number of events 8
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
|
General disorders
Dizziness
|
15.2%
5/33 • Number of events 5
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
22.2%
6/27 • Number of events 6
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
|
Gastrointestinal disorders
Nausea
|
15.2%
5/33 • Number of events 5
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
14.8%
4/27 • Number of events 4
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
|
General disorders
Somnolence
|
12.1%
4/33 • Number of events 4
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
18.5%
5/27 • Number of events 5
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
|
General disorders
Anxiety
|
6.1%
2/33 • Number of events 2
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
0.00%
0/27
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
|
Gastrointestinal disorders
Constipation
|
3.0%
1/33 • Number of events 1
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
0.00%
0/27
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
1/33 • Number of events 1
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
3.7%
1/27 • Number of events 1
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
|
General disorders
Edema
|
3.0%
1/33 • Number of events 1
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
3.7%
1/27 • Number of events 1
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
|
General disorders
Headache
|
3.0%
1/33 • Number of events 1
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
0.00%
0/27
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
|
Gastrointestinal disorders
Heartburn
|
3.0%
1/33 • Number of events 1
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
0.00%
0/27
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
|
Gastrointestinal disorders
Insomnia
|
3.0%
1/33 • Number of events 1
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
3.7%
1/27 • Number of events 1
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
|
General disorders
Weakness
|
3.0%
1/33 • Number of events 1
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
0.00%
0/27
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
|
General disorders
Confusion
|
0.00%
0/33
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
3.7%
1/27 • Number of events 1
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
|
General disorders
Disorientation
|
0.00%
0/33
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
3.7%
1/27 • Number of events 1
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
|
General disorders
Dyskinesia
|
0.00%
0/33
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
7.4%
2/27 • Number of events 2
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
|
General disorders
Fatigue
|
0.00%
0/33
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
3.7%
1/27 • Number of events 1
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
|
General disorders
Hallucinations
|
0.00%
0/33
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
3.7%
1/27 • Number of events 1
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
|
General disorders
Leg Cramps
|
0.00%
0/33
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
3.7%
1/27 • Number of events 1
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
|
General disorders
Slow kick in
|
0.00%
0/33
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
3.7%
1/27 • Number of events 1
There were a total of 61 participants enrolled to the study. One participant was removed from the study before he started study related procedures. Due to that, a total of 60 participants had adverse event data recorded.
|
Additional Information
Kelly E. Lyons, PhD
University of Kansas Medical Center
Phone: 913-588-7159
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place