Trial Outcomes & Findings for Anti-INFLammatory to Address Mood and Endothelial Dysfunction (INFLAMED) (NCT NCT01625845)
NCT ID: NCT01625845
Last Updated: 2015-12-03
Results Overview
Patients underwent ultrasound assessment of brachial FMD in accordance with established guidelines at pre- (0 weeks) and post- (12 weeks) treatment. After a 10-minute supine rest, high-resolution baseline images of the brachial artery were obtained from 3 consecutive cardiac cycles. Next, the forearm cuff was inflated to 250 mmHg for 5 minutes and then was rapidly deflated. At 60 and 90 seconds post-deflation, images from 3 consecutive cardiac cycles were acquired. FMD values were computed as the % change in brachial diameter at either 60 or 90 seconds after cuff deflation
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
0 and 12 weeks
Results posted on
2015-12-03
Participant Flow
Recruitment was open from June 28, 2012 to February 28, 2014. Participants were recruited from Eskenazi Health and Indiana University Health primary care clinics in Indianapolis. 1369 patients were screened, of whom 36 (2.6%) were eligible and provided informed consent. 16 patients (44%) attended the pre-treatment visit and were randomized.
Participant milestones
| Measure |
Pentoxifylline + Standard Treatment
Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
Placebo + Standard Treatment
Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Pentoxifylline + Standard Treatment
Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
Placebo + Standard Treatment
Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Anti-INFLammatory to Address Mood and Endothelial Dysfunction (INFLAMED)
Baseline characteristics by cohort
| Measure |
Pentoxifylline + Standard Treatment
n=10 Participants
Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
Placebo + Standard Treatment
n=6 Participants
Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 and 12 weeksPatients underwent ultrasound assessment of brachial FMD in accordance with established guidelines at pre- (0 weeks) and post- (12 weeks) treatment. After a 10-minute supine rest, high-resolution baseline images of the brachial artery were obtained from 3 consecutive cardiac cycles. Next, the forearm cuff was inflated to 250 mmHg for 5 minutes and then was rapidly deflated. At 60 and 90 seconds post-deflation, images from 3 consecutive cardiac cycles were acquired. FMD values were computed as the % change in brachial diameter at either 60 or 90 seconds after cuff deflation
Outcome measures
| Measure |
Placebo + Standard Treatment
n=3 Participants
Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
Pentoxifylline + Standard Treatment
n=5 Participants
Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
|---|---|---|
|
Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment
|
0.79 % change in brachial diameter
Standard Error 1.95
|
-1.18 % change in brachial diameter
Standard Error 1.48
|
PRIMARY outcome
Timeframe: 0 and 12 weeksSelf-reported depressive symptom severity was measured at pre- (0 weeks) and post- (12 weeks) treatment visits by the 20 depression items from the Symptom Checklist 90 (Hopkins Symptom Checklist depression scale; SCL-20). Each item on the scale ranges from 0 (not at all) to 4 (extremely). Total scores are the average across all response items and range from 0 to 4 with higher scores indicating greater levels of depressive symptoms.
Outcome measures
| Measure |
Placebo + Standard Treatment
n=3 Participants
Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
Pentoxifylline + Standard Treatment
n=5 Participants
Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
|---|---|---|
|
Change in Depressive Symptoms Severity (Hopkins Symptom Checklist Depression Scale; SCL-20) From Pre- to Post- Treatment
|
-1.41 Change in Total Score
Standard Error 0.34
|
-0.35 Change in Total Score
Standard Error 0.25
|
SECONDARY outcome
Timeframe: 0 and12 weeksPopulation: Participants with missing TNF-a data were excluded from this analysis.
A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
Outcome measures
| Measure |
Placebo + Standard Treatment
n=2 Participants
Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
Pentoxifylline + Standard Treatment
n=3 Participants
Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
|---|---|---|
|
Change in Circulating Tumor Necrosis Factor-Alpha (TNF-a) From Pre- to Post-Treatment
|
-0.47 pg/mL
Standard Error 0.10
|
-0.65 pg/mL
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 0 and 12 weeksA marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
Outcome measures
| Measure |
Placebo + Standard Treatment
n=3 Participants
Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
Pentoxifylline + Standard Treatment
n=5 Participants
Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
|---|---|---|
|
Change in Circulating Interleukin-6 (IL-6) From Pre- to Post-Treatment
|
1.84 pg/mL
Standard Error 1.34
|
-0.69 pg/mL
Standard Error 1.02
|
SECONDARY outcome
Timeframe: 0 and 12 weeksPopulation: One participant, with extreme outlier values at pre- and post-treatment, was excluded from analyses.
An anti-inflammatory cytokine measured from blood samples collected at pre- and post-treatment.
Outcome measures
| Measure |
Placebo + Standard Treatment
n=2 Participants
Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
Pentoxifylline + Standard Treatment
n=5 Participants
Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
|---|---|---|
|
Change in Circulating Interleukin-10 (IL-10) From Pre- to Post-Treatment
|
-0.66 pg/mL
Standard Error 0.54
|
-0.58 pg/mL
Standard Error 0.34
|
SECONDARY outcome
Timeframe: 0 and 12 weeksA marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
Outcome measures
| Measure |
Placebo + Standard Treatment
n=3 Participants
Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
Pentoxifylline + Standard Treatment
n=5 Participants
Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
|---|---|---|
|
Change in Interleukin-1ra (IL-1ra) From Pre- to Post-Treatment
|
25.00 pg/mL
Standard Error 99.55
|
2.32 pg/mL
Standard Error 75.03
|
SECONDARY outcome
Timeframe: 0 and 12 weeksA marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.
Outcome measures
| Measure |
Placebo + Standard Treatment
n=3 Participants
Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
Pentoxifylline + Standard Treatment
n=5 Participants
Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
|---|---|---|
|
Change in Circulating C-Reactive Protein (CRP) From Pre- to Post-Treatment
|
6.44 mg/L
Standard Error 1.74
|
-0.49 mg/L
Standard Error 1.34
|
Adverse Events
Pentoxifylline + Standard Treatment
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo + Standard Treatment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pentoxifylline + Standard Treatment
n=10 participants at risk
Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
Placebo + Standard Treatment
n=6 participants at risk
Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
|---|---|---|
|
General disorders
Complications after removing nodules during endoscopy (Chest pain, esophagitis, dizziness, bleeding)
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
0.00%
0/6 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasolabial abscess (Facial swelling)
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
0.00%
0/6 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
Injury, poisoning and procedural complications
Hearing issues after explosion
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
0.00%
0/6 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
Other adverse events
| Measure |
Pentoxifylline + Standard Treatment
n=10 participants at risk
Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
Placebo + Standard Treatment
n=6 participants at risk
Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemolyzed blood sample
|
0.00%
0/10 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
General disorders
Flushed
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
33.3%
2/6 • Number of events 2 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
General disorders
Hot flashes
|
0.00%
0/10 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
General disorders
Dizziness
|
30.0%
3/10 • Number of events 3 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
50.0%
3/6 • Number of events 3 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
General disorders
Facial Pimple
|
0.00%
0/10 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
0.00%
0/6 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
General disorders
Leg swelling
|
0.00%
0/10 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
General disorders
Headaches
|
30.0%
3/10 • Number of events 3 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
0.00%
0/6 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
Blood and lymphatic system disorders
Abnormalities in the complete blood cell count
|
0.00%
0/10 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
General disorders
Heartburn
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
0.00%
0/6 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
General disorders
Racing heart
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
0.00%
0/6 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
General disorders
Red eye
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
0.00%
0/6 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
General disorders
Diarrhea
|
30.0%
3/10 • Number of events 3 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
0.00%
0/6 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
General disorders
Blurred vision
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
Blood and lymphatic system disorders
Impaired fasting glucose
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
0.00%
0/6 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
General disorders
Low energy
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
0.00%
0/6 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
General disorders
Sleep disturbance
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
0.00%
0/6 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
General disorders
Stomach Pain
|
0.00%
0/10 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 2 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
General disorders
Nervousness / jittery hands
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
0.00%
0/6 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
General disorders
Leg pain
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
0.00%
0/6 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
General disorders
Back pain
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
0.00%
0/6 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
|
General disorders
Sweating
|
10.0%
1/10 • Number of events 1 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
0.00%
0/6 • Adverse event data were collected the recruitment initiation in June 2012 until study completion in May 2014. For each participant, adverse event data were collected between the pre- and post-treatment visits.
A brief questionnaire created by the investigators was administered at each study visit to identify potential adverse events. Each event was evaluated by the study physician, who also provided severity and study involvement ratings. Clinical management decisions were made by the study physician in conjunction with the participant's provider(s).
|
Additional Information
Jesse C. Stewart, Ph.D.
Indiana University-Purdue University Indianapolis (IUPUI)
Phone: (317) 274-6761
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place