Trial Outcomes & Findings for Omega 3 for Treatment of Depression in Patients With Heart Failure (NCT NCT02057406)
NCT ID: NCT02057406
Last Updated: 2018-05-14
Results Overview
Endpoint HAMD scores are mean values adjusted for age, race, sex, treatment site, and the baseline HAMD value. The range for the HAMD scores is 0 to 52 with higher scores indicating a greater severity of depressive symptoms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
108 participants
Primary outcome timeframe
Week 12
Results posted on
2018-05-14
Participant Flow
Participant milestones
| Measure |
2:1 EPA/DHA
400/200 EPA/DHA fish oil 2 grams
2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid (DHA) fish oil 2 grams
|
High EPA
Almost pure EPA 2 grams
High EPA
|
Placebo
Matched placebo corn oil capsules
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
36
|
|
Overall Study
COMPLETED
|
35
|
33
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
4
|
Reasons for withdrawal
| Measure |
2:1 EPA/DHA
400/200 EPA/DHA fish oil 2 grams
2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid (DHA) fish oil 2 grams
|
High EPA
Almost pure EPA 2 grams
High EPA
|
Placebo
Matched placebo corn oil capsules
Placebo
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Patient transportation issues
|
0
|
0
|
1
|
Baseline Characteristics
All blood samples obtained at baseline for the measurement of EPA were used in this analysis.
Baseline characteristics by cohort
| Measure |
2:1 EPA/DHA
n=36 Participants
400/200 EPA/DHA fish oil 2 grams
2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams
|
High EPA
n=36 Participants
Almost pure EPA 2 grams
High EPA
|
Placebo
n=36 Participants
Matched placebo corn oil capsules
Placebo
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.73 years
STANDARD_DEVIATION 16.14 • n=36 Participants
|
58.10 years
STANDARD_DEVIATION 10.16 • n=36 Participants
|
57.91 years
STANDARD_DEVIATION 11.68 • n=36 Participants
|
57.92 years
STANDARD_DEVIATION 12.79 • n=108 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=36 Participants
|
20 Participants
n=36 Participants
|
23 Participants
n=36 Participants
|
58 Participants
n=108 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=36 Participants
|
16 Participants
n=36 Participants
|
13 Participants
n=36 Participants
|
50 Participants
n=108 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=36 Participants
|
15 Participants
n=36 Participants
|
20 Participants
n=36 Participants
|
58 Participants
n=108 Participants
|
|
Race/Ethnicity, Customized
Black
|
13 Participants
n=36 Participants
|
19 Participants
n=36 Participants
|
16 Participants
n=36 Participants
|
48 Participants
n=108 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=108 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=36 Participants
|
36 participants
n=36 Participants
|
36 participants
n=36 Participants
|
108 participants
n=108 Participants
|
|
Treatment Site
Duke Unviersity Medical Center
|
12 Participants
n=36 Participants
|
13 Participants
n=36 Participants
|
13 Participants
n=36 Participants
|
38 Participants
n=108 Participants
|
|
Treatment Site
Thomas Jefferson University
|
12 Participants
n=36 Participants
|
10 Participants
n=36 Participants
|
10 Participants
n=36 Participants
|
32 Participants
n=108 Participants
|
|
Treatment Site
University of North Carolina
|
12 Participants
n=36 Participants
|
13 Participants
n=36 Participants
|
13 Participants
n=36 Participants
|
38 Participants
n=108 Participants
|
|
Hamilton Depression Rating Scale (HDRS) Score
|
22.2 units on a scale
STANDARD_DEVIATION 3.78 • n=36 Participants
|
22.67 units on a scale
STANDARD_DEVIATION 4.24 • n=36 Participants
|
23.56 units on a scale
STANDARD_DEVIATION 4.53 • n=36 Participants
|
22.82 units on a scale
STANDARD_DEVIATION 4.19 • n=108 Participants
|
|
Red Blood Cell/Plasma EPA
|
0.48 percentage of total fatty acids
STANDARD_DEVIATION 0.2 • n=36 Participants • All blood samples obtained at baseline for the measurement of EPA were used in this analysis.
|
0.51 percentage of total fatty acids
STANDARD_DEVIATION 0.24 • n=34 Participants • All blood samples obtained at baseline for the measurement of EPA were used in this analysis.
|
0.49 percentage of total fatty acids
STANDARD_DEVIATION 0.28 • n=35 Participants • All blood samples obtained at baseline for the measurement of EPA were used in this analysis.
|
0.49 percentage of total fatty acids
STANDARD_DEVIATION 0.24 • n=105 Participants • All blood samples obtained at baseline for the measurement of EPA were used in this analysis.
|
PRIMARY outcome
Timeframe: Week 12Endpoint HAMD scores are mean values adjusted for age, race, sex, treatment site, and the baseline HAMD value. The range for the HAMD scores is 0 to 52 with higher scores indicating a greater severity of depressive symptoms.
Outcome measures
| Measure |
2:1 EPA/DHA
n=36 Participants
400/200 EPA/DHA fish oil 2 grams
2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams
|
High EPA
n=36 Participants
Almost pure EPA 2 grams
High EPA
|
Placebo
n=36 Participants
Matched placebo corn oil capsules
Placebo
|
|---|---|---|---|
|
Endpoint Hamilton Depression Rating Scale (HAMD) Scores Adjusted for Age, Sex, Treatment Site, and Baseline HAMD Scores.
|
15.1 units on a scale
Standard Error 0.9
|
15.7 units on a scale
Standard Error 0.9
|
14.9 units on a scale
Standard Error 0.9
|
PRIMARY outcome
Timeframe: Week 12Population: The numbers at baseline reflect the total number of patients who provided samples for the assay of omega 3 percentage of total fatty acids. The numbers at endpoint reflect the total number of patients included in the intention to treat analysis.
Endpoint EPA values are mean values adjusted for age, race, sex, treatment site, and the baseline EPA value. Red blood cell/plasma EPA values are expressed as a percent of total identified fatty acids.
Outcome measures
| Measure |
2:1 EPA/DHA
n=36 Participants
400/200 EPA/DHA fish oil 2 grams
2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams
|
High EPA
n=36 Participants
Almost pure EPA 2 grams
High EPA
|
Placebo
n=36 Participants
Matched placebo corn oil capsules
Placebo
|
|---|---|---|---|
|
Endpoint Red Blood Cell/Plasma EPA Values Adjusted for Age, Sex, Treatment Site, and Baseline Red Blood Cell/Plasma EPA Values.
|
1.52 percentage of total fatty acids
Standard Error 0.15
|
1.86 percentage of total fatty acids
Standard Error 0.15
|
0.56 percentage of total fatty acids
Standard Error 0.15
|
Adverse Events
2:1 EPA/DHA
Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths
High EPA
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
2:1 EPA/DHA
n=36 participants at risk
400/200 EPA/DHA fish oil 2 grams
2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams
|
High EPA
n=36 participants at risk
Almost pure EPA 2 grams
High EPA
|
Placebo
n=36 participants at risk
Matched placebo corn oil capsules
Placebo
|
|---|---|---|---|
|
Vascular disorders
Hypertensive Urgency
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Cardiac disorders
Heart Failure Exacerbation
|
5.6%
2/36 • Number of events 2 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
8.3%
3/36 • Number of events 4 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
16.7%
6/36 • Number of events 7 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Cardiac disorders
Cardiac Arrest
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Cardiac disorders
Arrhythmia
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 2 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Cardiac disorders
Chest Pain on Exertion
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Vascular disorders
Mild Stroke
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Cardiac disorders
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
Other adverse events
| Measure |
2:1 EPA/DHA
n=36 participants at risk
400/200 EPA/DHA fish oil 2 grams
2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams
|
High EPA
n=36 participants at risk
Almost pure EPA 2 grams
High EPA
|
Placebo
n=36 participants at risk
Matched placebo corn oil capsules
Placebo
|
|---|---|---|---|
|
Infections and infestations
Bacteremia
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Eye disorders
Cataract Removal
|
5.6%
2/36 • Number of events 2 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Cardiac disorders
Chest Pain
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Infections and infestations
Bacterial Infection
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pharyngitis
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Gastrointestinal disorders
Non-Cardiac Chest Pain
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Cardiac disorders
Arrhythmia
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Cardiac disorders
Syncope
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Gastrointestinal disorders
Dehydration
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Infections and infestations
Infection
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Infections and infestations
Influenza A
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Musculoskeletal and connective tissue disorders
Right Lower Back/Flank Pain
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Musculoskeletal and connective tissue disorders
Nerve Pain
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Cardiac disorders
Heart failure exacerbation
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Musculoskeletal and connective tissue disorders
Arm Pain
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Burst Fracture, With Acute Exacerbation
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
1/36 • Number of events 1 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
0.00%
0/36 • Adverse events (AEs) were systematically monitored from enrollment, randomization, at the 12 week intervention and up until 30 days after study drug discontinuation. For patients who terminated from the study before the completion of the 12 week active intervention phase, a 30 day follow-up for AEs was ascertained.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place