Trial Outcomes & Findings for Effect of Ultra-low Dose Naloxone on Remifentanil-Induced Hyperalgesia (NCT NCT03066739)
NCT ID: NCT03066739
Last Updated: 2026-06-04
Results Overview
Mechanical Pain Threshold-determined by von Frey filaments around the incision site. The force required to elicit a pain response was recorded in grams. Higher values indicate higher pain thresholds (i.e., less hyperalgesia), while lower values indicate greater pain sensitivity.
TERMINATED
PHASE2
8 participants
24 hr Post-surgery
2026-06-04
Participant Flow
A total of 8 participants were enrolled. Six completed all study procedures. Two participants did not complete the study.
Participant milestones
| Measure |
LO-low Dose Remifentanil
low dose remifentanil (LO, 0.1 micrograms/kg/mL),
Remifentanil: 0.1 micrograms/kg/mL
|
HI-high Dose Remifentanil With Placebo
high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
Remifentanil+ Placebo: high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
|
HN-high Dose Remifentanil With Ultra-low Dose Naloxone
high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone).
Remifentanil +ultra-low dose naloxone: high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
6
|
|
Overall Study
COMPLETED
|
1
|
1
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
LO-low Dose Remifentanil
low dose remifentanil (LO, 0.1 micrograms/kg/mL),
Remifentanil: 0.1 micrograms/kg/mL
|
HI-high Dose Remifentanil With Placebo
high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
Remifentanil+ Placebo: high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
|
HN-high Dose Remifentanil With Ultra-low Dose Naloxone
high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone).
Remifentanil +ultra-low dose naloxone: high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Effect of Ultra-low Dose Naloxone on Remifentanil-Induced Hyperalgesia
Baseline characteristics by cohort
| Measure |
LO-low Dose Remifentanil
n=1 Participants
low dose remifentanil (LO, 0.1 micrograms/kg/mL),
Remifentanil: 0.1 micrograms/kg/mL
|
HI-high Dose Remifentanil With Placebo
n=1 Participants
high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
Remifentanil+ Placebo: high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
|
HN-high Dose Remifentanil With Ultra-low Dose Naloxone
n=4 Participants
high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone).
Remifentanil +ultra-low dose naloxone: high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
|
Age, Continuous
|
73 Years
STANDARD_DEVIATION 0 • n=9 Participants
|
68 Years
STANDARD_DEVIATION 0 • n=27 Participants
|
65 Years
STANDARD_DEVIATION 12.75 • n=267 Participants
|
66.83 Years
STANDARD_DEVIATION 10.41 • n=265 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=9 Participants
|
1 participants
n=27 Participants
|
4 participants
n=267 Participants
|
6 participants
n=265 Participants
|
|
Cold Pressor Pain Threshold
|
80 seconds
STANDARD_DEVIATION 0 • n=9 Participants
|
100 seconds
STANDARD_DEVIATION 0 • n=27 Participants
|
10.25 seconds
STANDARD_DEVIATION 8.54 • n=267 Participants
|
36.83 seconds
STANDARD_DEVIATION 36.83 • n=265 Participants
|
PRIMARY outcome
Timeframe: 24 hr Post-surgeryPopulation: Mechanical pain threshold measured using von Frey filaments at the incision site. Threshold is defined as the lowest force filament that produces a pain response
Mechanical Pain Threshold-determined by von Frey filaments around the incision site. The force required to elicit a pain response was recorded in grams. Higher values indicate higher pain thresholds (i.e., less hyperalgesia), while lower values indicate greater pain sensitivity.
Outcome measures
| Measure |
LO-low Dose Remifentanil
n=1 Participants
low dose remifentanil (LO, 0.1 micrograms/kg/mL),
Remifentanil: 0.1 micrograms/kg/mL
|
HI-high Dose Remifentanil With Placebo
n=1 Participants
high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
Remifentanil+ Placebo: high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
|
HN-high Dose Remifentanil With Ultra-low Dose Naloxone
n=4 Participants
high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone).
Remifentanil +ultra-low dose naloxone: high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone
|
|---|---|---|---|
|
Occurrence of Opioid-induced Hyperalgesia (OIH)
|
300 force in grams
Standard Deviation 0
|
300 force in grams
Standard Deviation 0
|
89.5 force in grams
Standard Deviation 137.6
|
PRIMARY outcome
Timeframe: 48 hr Post-surgeryPopulation: Participants with available mechanical pain threshold data at 48 hours post-surgery were included in the analysis. One participant in Arm 3 did not complete von Frey testing and was excluded from analysis. Mean pain scores were calculated from participants with complete outcome data.
Mechanical Pain Threshold-determined by von Frey filaments around the incision site.The force required to elicit a pain response was recorded in grams. Higher values indicate higher pain thresholds (i.e., less hyperalgesia), while lower values indicate greater pain sensitivity.
Outcome measures
| Measure |
LO-low Dose Remifentanil
n=1 Participants
low dose remifentanil (LO, 0.1 micrograms/kg/mL),
Remifentanil: 0.1 micrograms/kg/mL
|
HI-high Dose Remifentanil With Placebo
n=1 Participants
high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
Remifentanil+ Placebo: high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
|
HN-high Dose Remifentanil With Ultra-low Dose Naloxone
n=3 Participants
high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone).
Remifentanil +ultra-low dose naloxone: high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone
|
|---|---|---|---|
|
Occurrence of Opioid-induced Hyperalgesia (OIH)
|
300 force in grams
Standard Deviation 0
|
6 force in grams
Standard Deviation 0
|
117.3 force in grams
Standard Deviation 158.2
|
SECONDARY outcome
Timeframe: 24 hr post surgeryPopulation: Opioid consumption in oral morphine equivalents was not collected for this study. Therefore, no data are available for analysis of this outcome.
Opioid consumption required to control pain by Oral morphine equivalents
Outcome measures
| Measure |
LO-low Dose Remifentanil
n=1 Participants
low dose remifentanil (LO, 0.1 micrograms/kg/mL),
Remifentanil: 0.1 micrograms/kg/mL
|
HI-high Dose Remifentanil With Placebo
n=1 Participants
high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
Remifentanil+ Placebo: high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
|
HN-high Dose Remifentanil With Ultra-low Dose Naloxone
n=4 Participants
high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone).
Remifentanil +ultra-low dose naloxone: high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone
|
|---|---|---|---|
|
Opioid Consumption
|
47.6 milligram morphine equivalents (MME)
|
78.9 milligram morphine equivalents (MME)
|
36.4 milligram morphine equivalents (MME)
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: 48 hrs post surgeryPopulation: Opioid consumption in oral morphine equivalents was not collected for this study; therefore, no data are available for this outcome.
Opioid consumption required to control pain by Oral morphine equivalents
Outcome measures
| Measure |
LO-low Dose Remifentanil
n=1 Participants
low dose remifentanil (LO, 0.1 micrograms/kg/mL),
Remifentanil: 0.1 micrograms/kg/mL
|
HI-high Dose Remifentanil With Placebo
n=1 Participants
high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
Remifentanil+ Placebo: high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
|
HN-high Dose Remifentanil With Ultra-low Dose Naloxone
n=4 Participants
high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone).
Remifentanil +ultra-low dose naloxone: high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone
|
|---|---|---|---|
|
Opioid Consumption
|
74.8 milligram morphine equivalents (MME)
|
109.6 milligram morphine equivalents (MME)
|
63.4 milligram morphine equivalents (MME)
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: 24 hr post surgeryPopulation: Participants who completed the Cold Pressor Test at 24 hours post-surgery and had evaluable data were included in the analysis.
Pain threshold and pain tolerance were assessed using the Cold Pressor Test. Pain threshold was defined as the time to first pain sensation, and pain tolerance as the total duration the participant kept the hand immersed in cold water. Time was recorded in seconds. Higher values indicate greater pain tolerance and lower pain sensitivity.
Outcome measures
| Measure |
LO-low Dose Remifentanil
n=1 Participants
low dose remifentanil (LO, 0.1 micrograms/kg/mL),
Remifentanil: 0.1 micrograms/kg/mL
|
HI-high Dose Remifentanil With Placebo
n=1 Participants
high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
Remifentanil+ Placebo: high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
|
HN-high Dose Remifentanil With Ultra-low Dose Naloxone
n=4 Participants
high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone).
Remifentanil +ultra-low dose naloxone: high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone
|
|---|---|---|---|
|
Cold Pressure Test
first pain sensation
|
50 seconds
Standard Deviation 0
|
60 seconds
Standard Deviation 0
|
23.5 seconds
Standard Deviation 27.7
|
|
Cold Pressure Test
Pain tolerance
|
54 seconds
Standard Deviation 0
|
76 seconds
Standard Deviation 0
|
32.3 seconds
Standard Deviation 27
|
SECONDARY outcome
Timeframe: 48 hrs post surgeryPopulation: The analysis population included all enrolled participants who completed the Cold Pressor Test at 48 hours post-surgery. Due to early study closure related to low recruitment, only six participants were available for analysis.
Pain Threshold and Pain tolerance
Outcome measures
| Measure |
LO-low Dose Remifentanil
n=1 Participants
low dose remifentanil (LO, 0.1 micrograms/kg/mL),
Remifentanil: 0.1 micrograms/kg/mL
|
HI-high Dose Remifentanil With Placebo
n=1 Participants
high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
Remifentanil+ Placebo: high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
|
HN-high Dose Remifentanil With Ultra-low Dose Naloxone
n=4 Participants
high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone).
Remifentanil +ultra-low dose naloxone: high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone
|
|---|---|---|---|
|
Cold Pressure Test
first pain sensation
|
60 seconds
Standard Deviation 0
|
25 seconds
Standard Deviation 0
|
45.5 seconds
Standard Deviation 36.9
|
|
Cold Pressure Test
Pain Tolerance
|
180 seconds
Standard Deviation 0
|
38 seconds
Standard Deviation 0
|
55 seconds
Standard Deviation 45
|
SECONDARY outcome
Timeframe: Baseline, 4, 8 and 12h after extubation and again at 24h and 48h post-operativelyPopulation: Participants who had baseline Visual Analog Scale (VAS) pain scores recorded prior to surgery were included in the analysis.
Visual Analog Scale (VAS) pain scores are measured tp represent the severity of symptoms from 0 "no symptoms" to 10 "very severe symptoms." Its use is standard-of-care and is measured prior to surgery and at 4, 8 and 12h after extubation and again at 24h and 48h post-operatively.
Outcome measures
| Measure |
LO-low Dose Remifentanil
n=1 Participants
low dose remifentanil (LO, 0.1 micrograms/kg/mL),
Remifentanil: 0.1 micrograms/kg/mL
|
HI-high Dose Remifentanil With Placebo
n=1 Participants
high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
Remifentanil+ Placebo: high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
|
HN-high Dose Remifentanil With Ultra-low Dose Naloxone
n=4 Participants
high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone).
Remifentanil +ultra-low dose naloxone: high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone
|
|---|---|---|---|
|
Visual Analog Scale (VAS) Pain Scores
baseline
|
8 Scores on a Scale
Standard Deviation 0
|
5.5 Scores on a Scale
Standard Deviation 0
|
6.9 Scores on a Scale
Standard Deviation 1.6
|
|
Visual Analog Scale (VAS) Pain Scores
4 hours
|
6 Scores on a Scale
Standard Deviation 0
|
5 Scores on a Scale
Standard Deviation 0
|
6.8 Scores on a Scale
Standard Deviation 2.4
|
|
Visual Analog Scale (VAS) Pain Scores
8 hours
|
7 Scores on a Scale
Standard Deviation 0
|
5 Scores on a Scale
Standard Deviation 0
|
5 Scores on a Scale
Standard Deviation 1
|
|
Visual Analog Scale (VAS) Pain Scores
12 hours
|
7 Scores on a Scale
Standard Deviation 0
|
6 Scores on a Scale
Standard Deviation 0
|
6.3 Scores on a Scale
Standard Deviation 1.5
|
|
Visual Analog Scale (VAS) Pain Scores
24 hours
|
7 Scores on a Scale
Standard Deviation 0
|
6 Scores on a Scale
Standard Deviation 0
|
7.3 Scores on a Scale
Standard Deviation 1.5
|
|
Visual Analog Scale (VAS) Pain Scores
48 hours
|
6 Scores on a Scale
Standard Deviation 0
|
0 Scores on a Scale
Standard Deviation 0
|
7.8 Scores on a Scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: BaselinePopulation: The analysis population included participants who were assigned to a study arm and completed the baseline Short-Form McGill Pain Questionnaire. One enrolled participant was excluded from the analysis due to meeting an exclusion criterion.
The Short-Form McGill Pain Questionnaire Total Score (SF-MPQ PRI-T) is a validated patient-reported outcome measure assessing pain quality and intensity. The total score (PRI-T) is calculated by summing the 11 sensory descriptor scores (range 0-33) and the 4 affective descriptor scores (range 0-12), resulting in a total score range of 0-45. Each descriptor is rated on a 4-point intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. Higher scores indicate worse pain outcomes, and lower scores indicate less pain.
Outcome measures
| Measure |
LO-low Dose Remifentanil
n=1 Participants
low dose remifentanil (LO, 0.1 micrograms/kg/mL),
Remifentanil: 0.1 micrograms/kg/mL
|
HI-high Dose Remifentanil With Placebo
n=1 Participants
high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
Remifentanil+ Placebo: high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
|
HN-high Dose Remifentanil With Ultra-low Dose Naloxone
n=5 Participants
high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone).
Remifentanil +ultra-low dose naloxone: high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone
|
|---|---|---|---|
|
McGill Short Form Questionnaire
|
21 points
Standard Deviation 0
|
6 points
Standard Deviation 0
|
17.2 points
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analyses included participants who completed baseline assessments. One participant was excluded due to meeting exclusion criteria identified after enrollment.
Brief Pain Inventory assesses both pain intensity and pain unpleasantness (the emotional component of pain is considered to be a better metric of subject satisfaction and quality of life).Average pain severity was assessed using the Brief Pain Inventory (BPI). Participants rated their average pain during the past 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Outcome measures
| Measure |
LO-low Dose Remifentanil
n=1 Participants
low dose remifentanil (LO, 0.1 micrograms/kg/mL),
Remifentanil: 0.1 micrograms/kg/mL
|
HI-high Dose Remifentanil With Placebo
n=1 Participants
high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
Remifentanil+ Placebo: high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
|
HN-high Dose Remifentanil With Ultra-low Dose Naloxone
n=5 Participants
high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone).
Remifentanil +ultra-low dose naloxone: high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone
|
|---|---|---|---|
|
Brief Pain Inventory - Average Pain Severity
|
7 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
5.4 score on a scale
Standard Deviation 2.7
|
Adverse Events
LO-low Dose Remifentanil
HI-high Dose Remifentanil With Placebo
HN-high Dose Remifentanil With Ultra-low Dose Naloxone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LO-low Dose Remifentanil
n=1 participants at risk
low dose remifentanil (LO, 0.1 micrograms/kg/mL),
Remifentanil: 0.1 micrograms/kg/mL
|
HI-high Dose Remifentanil With Placebo
n=1 participants at risk
high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
Remifentanil+ Placebo: high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
|
HN-high Dose Remifentanil With Ultra-low Dose Naloxone
n=4 participants at risk
high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone).
Remifentanil +ultra-low dose naloxone: high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone
|
|---|---|---|---|
|
Social circumstances
Participant found ineligible after enrollment
|
0.00%
0/1 • From study enrollment (day of surgery) through 48 hours post-surgery.
Adverse events were collected from clinical encounters and participant communications from baseline (day of surgery) through 48 hours post-surgery. Post-enrollment identification of protocol ineligibility was recorded as an eligibility-related exclusion and not considered an adverse event. Definitions did not differ from ClinicalTrials.gov standards.
|
0.00%
0/1 • From study enrollment (day of surgery) through 48 hours post-surgery.
Adverse events were collected from clinical encounters and participant communications from baseline (day of surgery) through 48 hours post-surgery. Post-enrollment identification of protocol ineligibility was recorded as an eligibility-related exclusion and not considered an adverse event. Definitions did not differ from ClinicalTrials.gov standards.
|
25.0%
1/4 • Number of events 1 • From study enrollment (day of surgery) through 48 hours post-surgery.
Adverse events were collected from clinical encounters and participant communications from baseline (day of surgery) through 48 hours post-surgery. Post-enrollment identification of protocol ineligibility was recorded as an eligibility-related exclusion and not considered an adverse event. Definitions did not differ from ClinicalTrials.gov standards.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place