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Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients

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ClinicalTrials.gov Identifier: NCT00144300
Recruitment Status : Completed
First Posted : September 5, 2005
Results First Posted : November 4, 2011
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Parkinson Disease
Interventions Drug: Mirapex
Drug: Requip
Enrollment 246
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description Flexible: 0.125 mg 3 times daily up to maximum tolerated Flexible: 0.25 mg 3 times daily up to maximum tolerated
Period Title: Overall Study
Started 121 125
Completed 92 97
Not Completed 29 28
Reason Not Completed
Adverse Event             18             16
Protocol Violation             1             3
Lost to Follow-up             3             0
Withdrawal by Subject             6             6
Other reason (not specified)             1             3
Arm/Group Title Pramipexole Ropinirole Total
Hide Arm/Group Description Flexible: 0.125 mg 3 times daily up to maximum tolerated Flexible: 0.25 mg 3 times daily up to maximum tolerated Total of all reporting groups
Overall Number of Baseline Participants 121 125 246
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 121 participants 125 participants 246 participants
57.5  (9.3) 59.1  (8.7) 58.3  (9.0)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 121 participants 125 participants 246 participants
< 50 years 23 17 40
50 to < 65 years 71 74 145
65 to < 75 years 21 30 51
>= 75 years 6 4 10
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 125 participants 246 participants
Female
42
  34.7%
47
  37.6%
89
  36.2%
Male
79
  65.3%
78
  62.4%
157
  63.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 121 participants 125 participants 246 participants
Asian 1 1 2
Black 7 3 10
White 113 121 234
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 121 participants 125 participants 246 participants
171.3  (9.2) 171.6  (12.4) 171.5  (10.9)
[1]
Measure Description: Measurements collected for 120, 125 participants in Pramipexole, Ropinirole respectively
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 121 participants 125 participants 246 participants
81.32  (17.64) 82.80  (18.39) 82.07  (18.00)
[1]
Measure Description: Measurements collected for 119, 122 participants in Pramipexole, Ropinirole respectively
Duration of Parkinson's disease diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 121 participants 125 participants 246 participants
0.97  (1.15) 1.29  (1.70) 1.13  (1.46)
Hoehn and Yahr stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 121 participants 125 participants 246 participants
Stage 0 0 0 0
Stage 1 28 23 51
Stage 1.5 11 19 30
Stage 2 71 71 142
Stage 2.5 8 5 13
Stage 3 3 7 10
Stage 4 0 0 0
Stage 5 0 0 0
[1]
Measure Description: This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)
Alcohol history  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 121 participants 125 participants 246 participants
Does not drink 46 49 95
Has an average consumption 75 76 151
Fulfills criteria for Abuse/Dependence 0 0 0
1.Primary Outcome
Title Expert Panel Overall Assessment Following 2 Years on Drug
Hide Description Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS LOCF - full analysis set with last observation carry forward
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 115 119
Measure Type: Number
Unit of Measure: Participants
Have retinal deterioration 34 33
Have no retinal deterioration 81 86
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pramipexole, Ropinirole
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.07
Confidence Interval 95%
0.71 to 1.60
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Expert Panel Overall Assessment Following 1 Year on Drug
Hide Description Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments
Time Frame up to 1 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS LOCF - full analysis set with last observation carry forward
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 115 119
Measure Type: Number
Unit of Measure: Participants
Have retinal deterioration 28 21
Have no retinal deterioration 87 98
3.Secondary Outcome
Title Hoehn and Yahr Scale at Baseline
Hide Description This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
TS - treated set
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 121 125
Measure Type: Number
Unit of Measure: Participants
Stage 0 0 0
Stage 1 28 23
Stage 1.5 11 19
Stage 2 71 71
Stage 2.5 8 5
Stage 3 3 7
Stage 4 0 0
Stage 5 0 0
4.Secondary Outcome
Title Hoehn and Yahr Scale at 1 Year
Hide Description This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
TS - treated set
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 121 125
Measure Type: Number
Unit of Measure: Participants
Stage 0 1 1
Stage 1 33 22
Stage 1.5 9 16
Stage 2 70 72
Stage 2.5 8 8
Stage 3 0 6
Stage 4 0 0
Stage 5 0 0
5.Secondary Outcome
Title Hoehn and Yahr Scale at 2 Years
Hide Description This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
TS - treated set
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 121 125
Measure Type: Number
Unit of Measure: Participants
Stage 0 1 0
Stage 1 27 23
Stage 1.5 6 12
Stage 2 74 73
Stage 2.5 10 10
Stage 3 3 7
Stage 4 0 0
Stage 5 0 0
6.Secondary Outcome
Title Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline
Hide Description Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
TS - treated set
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 121 125
Mean (Standard Deviation)
Unit of Measure: Score on a scale
8.0  (3.8) 9.5  (4.7)
7.Secondary Outcome
Title Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year
Hide Description Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
TS - treated set
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 121 125
Mean (Standard Deviation)
Unit of Measure: Score on a scale
7.0  (4.3) 8.4  (5.0)
8.Secondary Outcome
Title Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year
Hide Description Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Time Frame Baseline, 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
TS - treated set
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 121 125
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-1.1  (3.4) -1.1  (3.6)
9.Secondary Outcome
Title Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years
Hide Description Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
TS - treated set
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 121 125
Mean (Standard Deviation)
Unit of Measure: Score on a scale
8.4  (4.6) 9.3  (5.2)
10.Secondary Outcome
Title Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years
Hide Description Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Time Frame Baseline, 2 year
Hide Outcome Measure Data
Hide Analysis Population Description
TS - treated set
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 121 125
Mean (Standard Deviation)
Unit of Measure: Score on a scale
0.4  (3.7) -0.2  (4.0)
11.Secondary Outcome
Title Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline
Hide Description Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
TS - treated set
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 121 125
Mean (Standard Deviation)
Unit of Measure: Score on a scale
20.7  (9.3) 22.4  (10.2)
12.Secondary Outcome
Title Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year
Hide Description Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
TS - treated set
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 121 125
Mean (Standard Deviation)
Unit of Measure: Score on a scale
17.7  (9.3) 19.8  (10.9)
13.Secondary Outcome
Title Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year
Hide Description Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Time Frame Baseline, 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
TS - treated set
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 121 125
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-3.0  (7.2) -2.6  (6.1)
14.Secondary Outcome
Title Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years
Hide Description Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
TS - treated set
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 121 125
Mean (Standard Deviation)
Unit of Measure: Score on a scale
19.7  (9.9) 20.9  (10.3)
15.Secondary Outcome
Title Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years
Hide Description Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Time Frame Baseline, 2 year
Hide Outcome Measure Data
Hide Analysis Population Description
TS - treated set
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 121 125
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-1.0  (7.9) -1.5  (7.7)
16.Secondary Outcome
Title Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline
Hide Description This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
TS - treated set
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 121 125
Mean (Standard Deviation)
Unit of Measure: Score on a scale
28.8  (11.6) 31.9  (13.4)
17.Secondary Outcome
Title Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year
Hide Description This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
TS - treated set
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 121 125
Mean (Standard Deviation)
Unit of Measure: Score on a scale
24.7  (11.8) 28.2  (14.5)
18.Secondary Outcome
Title Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year
Hide Description This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Time Frame Baseline, 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
TS - treated set
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 121 125
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-4.1  (8.9) -3.7  (8.2)
19.Secondary Outcome
Title Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years
Hide Description This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
TS - treated set
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 121 125
Mean (Standard Deviation)
Unit of Measure: Score on a scale
28.1  (12.9) 30.2  (14.1)
20.Secondary Outcome
Title Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years
Hide Description This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Time Frame Baseline, 2 year
Hide Outcome Measure Data
Hide Analysis Population Description
TS - treated set
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 121 125
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-0.7  (10.1) -1.7  (10.5)
21.Secondary Outcome
Title Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
Hide Description Clinical relevant abnormalities for clinical laboratory evaluations Biochemistry and Haematology) and Vital Signs. New abnormal findings or worsening of baseline conditions were reported.
Time Frame Screen (Baseline) and final visit (24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
TSlab - treated set with non-missing laboratory evaluations
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description:
Flexible: 0.125 mg 3 times daily up to maximum tolerated
Flexible: 0.25 mg 3 times daily up to maximum tolerated
Overall Number of Participants Analyzed 109 110
Measure Type: Number
Unit of Measure: participants
Haematocrit - Decrease 1 2
Haemoglobin - Decrease 8 5
Eosinophils - Increase 4 0
Phosphate - Decrease 0 2
Calcium - Increase 1 0
Glucose - Decrease 4 0
Time Frame up to 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pramipexole Ropinirole
Hide Arm/Group Description Flexible: 0.125 mg 3 times daily up to maximum tolerated Flexible: 0.25 mg 3 times daily up to maximum tolerated
All-Cause Mortality
Pramipexole Ropinirole
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Pramipexole Ropinirole
Affected / at Risk (%) Affected / at Risk (%)
Total   22/121 (18.18%)   21/125 (16.80%) 
Blood and lymphatic system disorders     
Anaemia  1  0/121 (0.00%)  1/125 (0.80%) 
Haemorrhagic anaemia  1  1/121 (0.83%)  0/125 (0.00%) 
Cardiac disorders     
Acute myocardial infarction  1  1/121 (0.83%)  0/125 (0.00%) 
Atrial fibrillation  1  2/121 (1.65%)  1/125 (0.80%) 
Bradycardia  1  0/121 (0.00%)  1/125 (0.80%) 
Cardiac failure congestive  1  2/121 (1.65%)  0/125 (0.00%) 
Coronary artery occlusion  1  0/121 (0.00%)  2/125 (1.60%) 
Gastrointestinal disorders     
Abdominal pain lower  1  1/121 (0.83%)  0/125 (0.00%) 
Colitis ischaemic  1  0/121 (0.00%)  1/125 (0.80%) 
Rectal haemorrhage  1  0/121 (0.00%)  1/125 (0.80%) 
Small intestinal obstruction  1  0/121 (0.00%)  1/125 (0.80%) 
General disorders     
Chest discomfort  1  0/121 (0.00%)  2/125 (1.60%) 
Hepatobiliary disorders     
Biliary colic  1  1/121 (0.83%)  0/125 (0.00%) 
Biliary dyskinesia  1  1/121 (0.83%)  0/125 (0.00%) 
Cholelithiasis  1  1/121 (0.83%)  0/125 (0.00%) 
Immune system disorders     
Hypersensitivity  1  1/121 (0.83%)  0/125 (0.00%) 
Infections and infestations     
Appendicitis  1  2/121 (1.65%)  0/125 (0.00%) 
Enterocolitis infectious  1  0/121 (0.00%)  1/125 (0.80%) 
Injury, poisoning and procedural complications     
Fall  1  1/121 (0.83%)  0/125 (0.00%) 
Femur fracture  1  2/121 (1.65%)  0/125 (0.00%) 
Hand fracture  1  0/121 (0.00%)  1/125 (0.80%) 
Hip fracture  1  0/121 (0.00%)  1/125 (0.80%) 
Incisional hernia  1  1/121 (0.83%)  0/125 (0.00%) 
Jaw fracture  1  0/121 (0.00%)  1/125 (0.80%) 
Lower limb fracture  1  2/121 (1.65%)  0/125 (0.00%) 
Post procedural haemorrhage  1  0/121 (0.00%)  1/125 (0.80%) 
Pubis fracture  1  1/121 (0.83%)  0/125 (0.00%) 
Rib fracture  1  1/121 (0.83%)  0/125 (0.00%) 
Road traffic accident  1  1/121 (0.83%)  2/125 (1.60%) 
Stab wound  1  1/121 (0.83%)  0/125 (0.00%) 
Tibia fracture  1  0/121 (0.00%)  1/125 (0.80%) 
Metabolism and nutrition disorders     
Fluid overload  1  0/121 (0.00%)  1/125 (0.80%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/121 (0.83%)  0/125 (0.00%) 
Arthritis  1  0/121 (0.00%)  1/125 (0.80%) 
Back pain  1  1/121 (0.83%)  0/125 (0.00%) 
Groin pain  1  1/121 (0.83%)  0/125 (0.00%) 
Lumbar spinal stenosis  1  1/121 (0.83%)  0/125 (0.00%) 
Osteoarthritis  1  2/121 (1.65%)  2/125 (1.60%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  5/121 (4.13%)  2/125 (1.60%) 
Malignant melanoma  1  0/121 (0.00%)  1/125 (0.80%) 
Malignant melanoma in situ  1  0/121 (0.00%)  1/125 (0.80%) 
Ovarian granulosa-theca cell tumour  1  1/121 (0.83%)  0/125 (0.00%) 
Prostate cancer  1  1/121 (0.83%)  1/125 (0.80%) 
Small cell lung cancer stage unspecified  1  1/121 (0.83%)  0/125 (0.00%) 
Squamous cell carcinoma  1  0/121 (0.00%)  2/125 (1.60%) 
Squamous cell carcinoma of skin  1  1/121 (0.83%)  0/125 (0.00%) 
Transitional cell carcinoma  1  0/121 (0.00%)  1/125 (0.80%) 
Uterine leiomyoma  1  1/121 (0.83%)  0/125 (0.00%) 
Nervous system disorders     
Brain mass  1  1/121 (0.83%)  0/125 (0.00%) 
Loss of consciousness  1  0/121 (0.00%)  1/125 (0.80%) 
Syncope  1  0/121 (0.00%)  1/125 (0.80%) 
Transient global amnesia  1  0/121 (0.00%)  1/125 (0.80%) 
Psychiatric disorders     
Delirium  1  0/121 (0.00%)  1/125 (0.80%) 
Delusion  1  0/121 (0.00%)  1/125 (0.80%) 
Hallucination, visual  1  0/121 (0.00%)  1/125 (0.80%) 
Psychotic disorder  1  1/121 (0.83%)  0/125 (0.00%) 
Renal and urinary disorders     
Urinary incontinence  1  0/121 (0.00%)  1/125 (0.80%) 
Reproductive system and breast disorders     
Cystocele  1  0/121 (0.00%)  1/125 (0.80%) 
Endometrial hyperplasia  1  1/121 (0.83%)  0/125 (0.00%) 
Hyperthecosis  1  1/121 (0.83%)  0/125 (0.00%) 
Prostatomegaly  1  1/121 (0.83%)  0/125 (0.00%) 
Uterine haemorrhage  1  0/121 (0.00%)  1/125 (0.80%) 
Uterine polyp  1  1/121 (0.83%)  0/125 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  1/121 (0.83%)  0/125 (0.00%) 
Vascular disorders     
Thrombosis  1  0/121 (0.00%)  1/125 (0.80%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 13.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pramipexole Ropinirole
Affected / at Risk (%) Affected / at Risk (%)
Total   97/121 (80.17%)   101/125 (80.80%) 
Eye disorders     
Vision blurred  1  7/121 (5.79%)  4/125 (3.20%) 
Gastrointestinal disorders     
Abdominal pain upper  1  3/121 (2.48%)  7/125 (5.60%) 
Constipation  1  18/121 (14.88%)  26/125 (20.80%) 
Diarrhoea  1  6/121 (4.96%)  9/125 (7.20%) 
Dry mouth  1  4/121 (3.31%)  7/125 (5.60%) 
Dyspepsia  1  4/121 (3.31%)  7/125 (5.60%) 
Dysphagia  1  1/121 (0.83%)  8/125 (6.40%) 
Nausea  1  31/121 (25.62%)  59/125 (47.20%) 
Vomiting  1  3/121 (2.48%)  12/125 (9.60%) 
General disorders     
Chest pain  1  6/121 (4.96%)  7/125 (5.60%) 
Fatigue  1  27/121 (22.31%)  25/125 (20.00%) 
Oedema peripheral  1  22/121 (18.18%)  18/125 (14.40%) 
Infections and infestations     
Nasopharyngitis  1  17/121 (14.05%)  16/125 (12.80%) 
Sinusitis  1  5/121 (4.13%)  7/125 (5.60%) 
Upper respiratory tract infection  1  12/121 (9.92%)  13/125 (10.40%) 
Urinary tract infection  1  7/121 (5.79%)  4/125 (3.20%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  9/121 (7.44%)  12/125 (9.60%) 
Back pain  1  17/121 (14.05%)  9/125 (7.20%) 
Muscle spasms  1  7/121 (5.79%)  9/125 (7.20%) 
Musculoskeletal pain  1  3/121 (2.48%)  7/125 (5.60%) 
Myalgia  1  2/121 (1.65%)  8/125 (6.40%) 
Pain in extremity  1  12/121 (9.92%)  13/125 (10.40%) 
Nervous system disorders     
Dizziness  1  27/121 (22.31%)  35/125 (28.00%) 
Dizziness postural  1  9/121 (7.44%)  9/125 (7.20%) 
Headache  1  15/121 (12.40%)  27/125 (21.60%) 
Hypoaesthesia  1  5/121 (4.13%)  9/125 (7.20%) 
Paraesthesia  1  0/121 (0.00%)  10/125 (8.00%) 
Somnolence  1  53/121 (43.80%)  71/125 (56.80%) 
Sudden onset of sleep  1  11/121 (9.09%)  16/125 (12.80%) 
Psychiatric disorders     
Abnormal dreams  1  8/121 (6.61%)  7/125 (5.60%) 
Anxiety  1  10/121 (8.26%)  14/125 (11.20%) 
Depression  1  8/121 (6.61%)  15/125 (12.00%) 
Insomnia  1  19/121 (15.70%)  27/125 (21.60%) 
Sleep disorder  1  9/121 (7.44%)  10/125 (8.00%) 
Reproductive system and breast disorders     
Erectile dysfunction  1  7/121 (5.79%)  4/125 (3.20%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  8/121 (6.61%)  7/125 (5.60%) 
Skin and subcutaneous tissue disorders     
Rash  1  6/121 (4.96%)  10/125 (8.00%) 
Vascular disorders     
Hypertension  1  9/121 (7.44%)  10/125 (8.00%) 
Orthostatic hypotension  1  10/121 (8.26%)  14/125 (11.20%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Other - Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00144300    
Other Study ID Numbers: 248.538
First Submitted: September 2, 2005
First Posted: September 5, 2005
Results First Submitted: September 16, 2011
Results First Posted: November 4, 2011
Last Update Posted: March 14, 2014