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Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C (COPE-HCV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00919633
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : April 30, 2014
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Corporate Technologies and New Ventures

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: interferon alfa-2b
Drug: peginterferon alfa-2b
Drug: ribavirin, USP
Device: external drug infusion pump
Enrollment 116
Recruitment Details Enrollment 09-Jun-2009, final subject complete 19-Jun-2012.
Pre-assignment Details 210 screened, 116 randomized, 106 received at least 1 dose of study drug.
Arm/Group Title Group 4: Peginterferon Alfa-2b (1.5 μg/kg) Group 1: Interferon Alfa-2b (Dose 1) Group 2: Interferon Alfa-2b (Dose 2) Group 3: Interferon Alfa-2b (Dose 3)
Hide Arm/Group Description

subcutaneous weekly for 48 weeks

peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

Period Title: Overall Study
Started 28 25 27 26
Completed 6 10 4 5
Not Completed 22 15 23 21
Reason Not Completed
Adverse Event             1             9             12             10
Death             0             0             2             0
Lack of Efficacy             17             3             2             3
Withdrawal by Subject             1             2             4             3
Lost to Follow-up             3             1             0             2
Withdraw consent post transition to SOC             0             0             1             1
Protocol Violation             0             0             0             1
Physician Decision             0             0             0             1
Request of withdrawal w/o future contact             0             0             1             0
Viral rebound outside protocol timepoint             0             0             1             0
Arm/Group Title Group 4: Peginterferon Alfa-2b (1.5 μg/kg) Group 1: Interferon Alfa-2b (Dose 1) Group 2: Interferon Alfa-2b (Dose 2) Group 3: Interferon Alfa-2b (Dose 3) Total
Hide Arm/Group Description

subcutaneous weekly for 48 weeks

peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

Total of all reporting groups
Overall Number of Baseline Participants 28 25 27 26 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 25 participants 27 participants 26 participants 106 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
 100.0%
25
 100.0%
27
 100.0%
26
 100.0%
106
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 28 participants 25 participants 27 participants 26 participants 106 participants
51.2
(48.5 to 53.8)
51.5
(47.0 to 56.1)
51.3
(46.7 to 55.5)
49.1
(44.6 to 53.2)
51.2
(44.6 to 56.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 25 participants 27 participants 26 participants 106 participants
Female
8
  28.6%
12
  48.0%
11
  40.7%
12
  46.2%
43
  40.6%
Male
20
  71.4%
13
  52.0%
16
  59.3%
14
  53.8%
63
  59.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 25 participants 27 participants 26 participants 106 participants
Hispanic or Latino
2
   7.1%
3
  12.0%
3
  11.1%
4
  15.4%
12
  11.3%
Not Hispanic or Latino
26
  92.9%
22
  88.0%
24
  88.9%
22
  84.6%
94
  88.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 25 participants 27 participants 26 participants 106 participants
American Indian or Alaska Native
1
   3.6%
0
   0.0%
0
   0.0%
1
   3.8%
2
   1.9%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   3.7%
0
   0.0%
1
   0.9%
Black or African American
5
  17.9%
2
   8.0%
4
  14.8%
3
  11.5%
14
  13.2%
White
21
  75.0%
23
  92.0%
22
  81.5%
21
  80.8%
87
  82.1%
More than one race
1
   3.6%
0
   0.0%
0
   0.0%
1
   3.8%
2
   1.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 25 participants 27 participants 26 participants 106 participants
28 25 27 26 106
Hepatitis C Genotype   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 25 participants 27 participants 26 participants 106 participants
1a 24 19 23 19 85
1b 4 6 4 7 21
[1]
Measure Description: 1a, 1b
1.Primary Outcome
Title Viral Load: Incidence of Sustained Virologic Response (SVR)
Hide Description [Not Specified]
Time Frame 24 weeks after treatment is complete
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 4: Peginterferon Alfa-2b (1.5 μg/kg) Group 1: Interferon Alfa-2b (Dose 1) Group 2: Interferon Alfa-2b (Dose 2) Group 3: Interferon Alfa-2b (Dose 3)
Hide Arm/Group Description:

subcutaneous weekly for 48 weeks

peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

Overall Number of Participants Analyzed 28 25 27 26
Measure Type: Number
Unit of Measure: participants
4 7 2 4
2.Primary Outcome
Title Safety/Tolerability
Hide Description [Not Specified]
Time Frame Through study week 72
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Rapid Virologic Response (RVR)
Hide Description [Not Specified]
Time Frame Study Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 4: Peginterferon Alfa-2b (1.5 μg/kg) Group 1: Interferon Alfa-2b (Dose 1) Group 2: Interferon Alfa-2b (Dose 2) Group 3: Interferon Alfa-2b (Dose 3)
Hide Arm/Group Description:

subcutaneous weekly for 48 weeks

peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

Overall Number of Participants Analyzed 28 25 27 26
Measure Type: Number
Unit of Measure: participants
2 4 7 11
4.Secondary Outcome
Title Early Virologic Response (EVR)
Hide Description [Not Specified]
Time Frame Study week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 4: Peginterferon Alfa-2b (1.5 μg/kg) Group 1: Interferon Alfa-2b (Dose 1) Group 2: Interferon Alfa-2b (Dose 2) Group 3: Interferon Alfa-2b (Dose 3)
Hide Arm/Group Description:

subcutaneous weekly for 48 weeks

peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

Overall Number of Participants Analyzed 28 25 27 26
Measure Type: Number
Unit of Measure: participants
13 16 17 13
5.Secondary Outcome
Title End-of-treatment Response (EOT)
Hide Description [Not Specified]
Time Frame Study week 48
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Pharmacokinetics
Hide Description [Not Specified]
Time Frame through Study Week 72
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Pharmacodynamics
Hide Description [Not Specified]
Time Frame through Study Week 72
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Functional Health, Depression Score, and Fatigue Level
Hide Description [Not Specified]
Time Frame through Study Week 72
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Viral Decay
Hide Description [Not Specified]
Time Frame 12 weeks of treatment
Outcome Measure Data Not Reported
Time Frame Adverse events were collected the duration of the study from activation to closure.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PEGINTRON 1.5 INTRON A 80,000 INTRON A 120,000 INTRON A 160,000
Hide Arm/Group Description

subcutaneous weekly for 48 weeks

peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

All-Cause Mortality
PEGINTRON 1.5 INTRON A 80,000 INTRON A 120,000 INTRON A 160,000
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PEGINTRON 1.5 INTRON A 80,000 INTRON A 120,000 INTRON A 160,000
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/28 (7.14%)      6/25 (24.00%)      5/27 (18.52%)      6/26 (23.08%)    
Blood and lymphatic system disorders         
Anaemia  1  0/28 (0.00%)  0 1/25 (4.00%)  1 0/27 (0.00%)  0 1/26 (3.85%)  1
Cardiac disorders         
Arteriosclerosis Coronary Artery  1  0/28 (0.00%)  0 0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Hypertensive Heart Disease  1  0/28 (0.00%)  0 0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Gastrointestinal disorders         
Vomiting  1  0/28 (0.00%)  0 0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1
Melaena  1  1/28 (3.57%)  1 0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Hepatobiliary disorders         
Liver Disorder  1  1/28 (3.57%)  1 0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Infections and infestations         
Bronchitis  1  0/28 (0.00%)  0 0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1
Cellulitis  1  0/28 (0.00%)  0 0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1
Injection Site Cellulitis  1  0/28 (0.00%)  0 0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1
Staphylococcal Abscess  1  0/28 (0.00%)  0 0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1
Appendicitis  1  1/28 (3.57%)  1 0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Pneumonia  1  0/28 (0.00%)  0 2/25 (8.00%)  2 2/27 (7.41%)  2 0/26 (0.00%)  0
Pneumonia Moraxella  1  0/28 (0.00%)  0 0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Streptococcal Abscess  1  0/28 (0.00%)  0 0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Metabolism and nutrition disorders         
Dehydration  1  1/28 (3.57%)  1 0/25 (0.00%)  0 1/27 (3.70%)  1 0/26 (0.00%)  0
Type 2 Diabetes Mellitus  1  0/28 (0.00%)  0 1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Musculoskeletal Pain  1  0/28 (0.00%)  0 0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1
Musculoskeletal Chest Pain  1  1/28 (3.57%)  1 0/25 (0.00%)  0 0/27 (0.00%)  0 0/26 (0.00%)  0
Nervous system disorders         
Syncope  1  0/28 (0.00%)  0 2/25 (8.00%)  2 0/27 (0.00%)  0 0/26 (0.00%)  0
Psychiatric disorders         
Suicidal Ideation  1  0/28 (0.00%)  0 0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1
Suicide Attempt  1  0/28 (0.00%)  0 0/25 (0.00%)  0 0/27 (0.00%)  0 1/26 (3.85%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEGINTRON 1.5 INTRON A 80,000 INTRON A 120,000 INTRON A 160,000
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/28 (100.00%)      25/25 (100.00%)      27/27 (100.00%)      26/26 (100.00%)    
Blood and lymphatic system disorders         
Neutropenia  1  4/28 (14.29%)  4 5/25 (20.00%)  5 9/27 (33.33%)  9 9/26 (34.62%)  9
Anaemia  1  7/28 (25.00%)  7 5/25 (20.00%)  5 13/27 (48.15%)  13 4/26 (15.38%)  4
Thrombocytopenia  1  3/28 (10.71%)  3 5/25 (20.00%)  5 6/27 (22.22%)  6 3/26 (11.54%)  3
Leukopenia  1  2/28 (7.14%)  2 2/25 (8.00%)  2 2/27 (7.41%)  2 2/26 (7.69%)  2
Cardiac disorders         
Angina Pectoris  1  0/28 (0.00%)  0 0/25 (0.00%)  0 0/27 (0.00%)  0 2/26 (7.69%)  2
Techycardia  1  1/28 (3.57%)  1 3/25 (12.00%)  3 0/27 (0.00%)  0 0/26 (0.00%)  0
Ear and labyrinth disorders         
Ear Pain  1  0/28 (0.00%)  0 2/25 (8.00%)  2 0/27 (0.00%)  0 0/26 (0.00%)  0
Eye disorders         
Photophobia  1  0/28 (0.00%)  0 3/25 (12.00%)  3 0/27 (0.00%)  0 1/26 (3.85%)  1
Visual Acuity Reduced  1  0/28 (0.00%)  0 2/25 (8.00%)  2 0/27 (0.00%)  0 1/26 (3.85%)  1
Dry Eye  1  0/28 (0.00%)  0 1/25 (4.00%)  1 2/27 (7.41%)  2 0/26 (0.00%)  0
Eye Pain  1  0/28 (0.00%)  0 1/25 (4.00%)  1 2/27 (7.41%)  2 0/26 (0.00%)  0
Retinal Exudates  1  0/28 (0.00%)  0 2/25 (8.00%)  2 1/27 (3.70%)  1 0/26 (0.00%)  0
Gastrointestinal disorders         
Nausea  1  10/28 (35.71%)  10 15/25 (60.00%)  15 13/27 (48.15%)  13 18/26 (69.23%)  18
Vomiting  1  1/28 (3.57%)  1 2/25 (8.00%)  2 6/27 (22.22%)  6 8/26 (30.77%)  8
Diarrhoea  1  4/28 (14.29%)  4 4/25 (16.00%)  4 8/27 (29.63%)  8 6/26 (23.08%)  6
Constipation  1  1/28 (3.57%)  1 1/25 (4.00%)  1 3/27 (11.11%)  3 3/26 (11.54%)  3
Dry Mouth  1  0/28 (0.00%)  0 0/25 (0.00%)  0 2/27 (7.41%)  2 2/26 (7.69%)  2
Stomatitis  1  0/28 (0.00%)  0 1/25 (4.00%)  1 3/27 (11.11%)  3 2/26 (7.69%)  2
Abdominal Pain  1  0/28 (0.00%)  0 2/25 (8.00%)  2 3/27 (11.11%)  3 1/26 (3.85%)  1
Abdominal Pain Upper  1  1/28 (3.57%)  1 0/25 (0.00%)  0 2/27 (7.41%)  2 1/26 (3.85%)  1
Dyspepsia  1  0/28 (0.00%)  0 1/25 (4.00%)  1 2/27 (7.41%)  2 1/26 (3.85%)  1
Gingival Pain  1  1/28 (3.57%)  1 0/25 (0.00%)  0 2/27 (7.41%)  2 0/26 (0.00%)  0
General disorders         
Fatigue  1  14/28 (50.00%)  14 16/25 (64.00%)  16 15/27 (55.56%)  15 16/26 (61.54%)  16
Influenza Like Illness  1  11/28 (39.29%)  11 8/25 (32.00%)  8 9/27 (33.33%)  9 11/26 (42.31%)  11
Pyrexia  1  7/28 (25.00%)  7 10/25 (40.00%)  10 11/27 (40.74%)  11 9/26 (34.62%)  9
Asthenia  1  0/28 (0.00%)  0 0/25 (0.00%)  0 3/27 (11.11%)  3 5/26 (19.23%)  5
Chills  1  10/28 (35.71%)  10 6/25 (24.00%)  6 3/27 (11.11%)  3 5/26 (19.23%)  5
Irritability  1  4/28 (14.29%)  4 5/25 (20.00%)  5 5/27 (18.52%)  5 5/26 (19.23%)  5
Oedema Peripheral  1  0/28 (0.00%)  0 0/25 (0.00%)  0 2/27 (7.41%)  2 3/26 (11.54%)  3
Non-Cardiac Chest Pain  1  0/28 (0.00%)  0 2/25 (8.00%)  2 1/27 (3.70%)  1 2/26 (7.69%)  2
Pain  1  9/28 (32.14%)  9 4/25 (16.00%)  4 2/27 (7.41%)  2 2/26 (7.69%)  2
Infections and infestations         
Cellulitis  1  2/28 (7.14%)  2 0/25 (0.00%)  0 2/27 (7.41%)  2 3/26 (11.54%)  3
Upper Respiratory Tract Infection  1  2/28 (7.14%)  2 5/25 (20.00%)  5 5/27 (18.52%)  5 3/26 (11.54%)  3
Bronchitis  1  0/28 (0.00%)  0 4/25 (16.00%)  4 4/27 (14.81%)  4 0/26 (0.00%)  0
Urinary Tract Infection  1  1/28 (3.57%)  1 0/25 (0.00%)  0 2/27 (7.41%)  2 1/26 (3.85%)  1
Sinusitis  1  1/28 (3.57%)  1 2/25 (8.00%)  2 2/27 (7.41%)  2 0/26 (0.00%)  0
Investigations         
Blood Uric Acid Increased  1  0/28 (0.00%)  0 0/25 (0.00%)  0 0/27 (0.00%)  0 2/26 (7.69%)  2
Weight Decreased  1  1/28 (3.57%)  1 2/25 (8.00%)  2 3/27 (11.11%)  3 2/26 (7.69%)  2
Metabolism and nutrition disorders         
Decreased Appetite  1  4/28 (14.29%)  4 5/25 (20.00%)  5 8/27 (29.63%)  8 11/26 (42.31%)  11
Dehydration  1  0/28 (0.00%)  0 2/25 (8.00%)  2 0/27 (0.00%)  0 1/26 (3.85%)  1
Musculoskeletal and connective tissue disorders         
Myalgia  1  9/28 (32.14%)  9 7/25 (28.00%)  7 7/27 (25.93%)  7 11/26 (42.31%)  11
Arthralgia  1  3/28 (10.71%)  3 1/25 (4.00%)  1 6/27 (22.22%)  6 6/26 (23.08%)  6
Back Pain  1  1/28 (3.57%)  1 2/25 (8.00%)  2 5/27 (18.52%)  5 5/26 (19.23%)  5
Muscle Spasms  1  2/28 (7.14%)  2 6/25 (24.00%)  6 4/27 (14.81%)  4 2/26 (7.69%)  2
Muscular Weakness  1  0/28 (0.00%)  0 0/25 (0.00%)  0 2/27 (7.41%)  2 1/26 (3.85%)  1
Nervous system disorders         
Headache  1  11/28 (39.29%)  11 15/25 (60.00%)  15 18/27 (66.67%)  18 17/26 (65.38%)  17
Dizziness  1  1/28 (3.57%)  1 6/25 (24.00%)  6 9/27 (33.33%)  9 4/26 (15.38%)  4
Disturbance in Attention  1  0/28 (0.00%)  0 2/25 (8.00%)  2 3/27 (11.11%)  3 3/26 (11.54%)  3
Memory Impairment  1  1/28 (3.57%)  1 2/25 (8.00%)  2 3/27 (11.11%)  3 2/26 (7.69%)  2
Dysgeusia  1  1/28 (3.57%)  1 1/25 (4.00%)  1 4/27 (14.81%)  4 0/26 (0.00%)  0
Hypersomnia  1  0/28 (0.00%)  0 0/25 (0.00%)  0 2/27 (7.41%)  2 0/26 (0.00%)  0
Hypogeusia  1  0/28 (0.00%)  0 0/25 (0.00%)  0 2/27 (7.41%)  2 0/26 (0.00%)  0
Psychiatric disorders         
Depression  1  5/28 (17.86%)  5 11/25 (44.00%)  11 7/27 (25.93%)  7 8/26 (30.77%)  8
Insomnia  1  11/28 (39.29%)  11 6/25 (24.00%)  6 5/27 (18.52%)  5 7/26 (26.92%)  7
Anxiety  1  3/28 (10.71%)  3 4/25 (16.00%)  4 4/27 (14.81%)  4 1/26 (3.85%)  1
Confusional State  1  0/28 (0.00%)  0 2/25 (8.00%)  2 2/27 (7.41%)  2 0/26 (0.00%)  0
Libido Decreased  1  0/28 (0.00%)  0 0/25 (0.00%)  0 2/27 (7.41%)  2 0/26 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  2/28 (7.14%)  2 8/25 (32.00%)  8 4/27 (14.81%)  4 7/26 (26.92%)  7
Dyspnoea  1  2/28 (7.14%)  2 4/25 (16.00%)  4 8/27 (29.63%)  8 6/26 (23.08%)  6
Productive Cough  1  1/28 (3.57%)  1 2/25 (8.00%)  2 3/27 (11.11%)  3 3/26 (11.54%)  3
Oropharyngeal Pain  1  2/28 (7.14%)  2 2/25 (8.00%)  2 1/27 (3.70%)  1 2/26 (7.69%)  2
Respiratory Tract Congestion  1  2/28 (7.14%)  2 3/25 (12.00%)  3 4/27 (14.81%)  4 2/26 (7.69%)  2
Nasal Congestion  1  1/28 (3.57%)  1 1/25 (4.00%)  1 2/27 (7.41%)  2 1/26 (3.85%)  1
Sinus Congestion  1  2/28 (7.14%)  2 1/25 (4.00%)  1 2/27 (7.41%)  2 1/26 (3.85%)  1
Epistaxis  1  1/28 (3.57%)  1 1/25 (4.00%)  1 3/27 (11.11%)  3 0/26 (0.00%)  0
Skin and subcutaneous tissue disorders         
Alopecia  1  3/28 (10.71%)  3 10/25 (40.00%)  10 8/27 (29.63%)  8 7/26 (26.92%)  7
Rash  1  6/28 (21.43%)  6 7/25 (28.00%)  7 6/27 (22.22%)  6 6/26 (23.08%)  6
Erythema  1  1/28 (3.57%)  1 0/25 (0.00%)  0 0/27 (0.00%)  0 3/26 (11.54%)  3
Pruritus  1  4/28 (14.29%)  4 2/25 (8.00%)  2 6/27 (22.22%)  6 3/26 (11.54%)  3
Dry Skin  1  3/28 (10.71%)  3 4/25 (16.00%)  4 1/27 (3.70%)  1 2/26 (7.69%)  2
Dermatitis  1  2/28 (7.14%)  2 1/25 (4.00%)  1 0/27 (0.00%)  0 0/26 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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.
 
Results Point of Contact
Name/Title: Study Trial Manager
Organization: Medtronic, Inc.
Phone: 763-505-4594
Responsible Party: Medtronic Corporate Technologies and New Ventures
ClinicalTrials.gov Identifier: NCT00919633     History of Changes
Other Study ID Numbers: 4316001
First Submitted: June 10, 2009
First Posted: June 12, 2009
Results First Submitted: March 28, 2014
Results First Posted: April 30, 2014
Last Update Posted: October 24, 2018