Trial Outcomes & Findings for Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery (NCT NCT03052816)
NCT ID: NCT03052816
Last Updated: 2023-05-19
Results Overview
Visual Analog Scores (VAS) Scores in the morning of post op day 1. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
66 participants
Primary outcome timeframe
Visual Analog Scores (VAS) Score in the morning of post op day 1 at 7am.
Results posted on
2023-05-19
Participant Flow
Study approved January 30th, 2017. First patient recruited April 2017. Between April 2017 and April 2018, 138 women who were scheduled for surgery were assessed. 72 patients were excluded. Sixty-six patients were randomized to the ICE-T or Standard protocols. Of the 33 patients who were randomized to the ICE-T regimen, three were excluded after randomization. Ultimately, thirty patients in the ICE-T arm and 33 patients in the Standard arm were analyzed.
138 Patients assessed for eligibility. 72 patients excluded: 55 not meeting inclusion criteria and 17 declined to participate. 66 were randomized.
Participant milestones
| Measure |
ICE T Postoperative Pain Regimen
1. ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.
2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with PO Tylenol and PO toradol PRN.
Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough
|
Standard Postoperative Pain Regimen
1. Motrin 600mg PO Q4h PRN pain 1-3
2. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain
3. Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Motrin/Percocet/Dilaudid for breakthrough: Standard regimen
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
30
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
ICE T Postoperative Pain Regimen
1. ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.
2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with PO Tylenol and PO toradol PRN.
Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough
|
Standard Postoperative Pain Regimen
1. Motrin 600mg PO Q4h PRN pain 1-3
2. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain
3. Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Motrin/Percocet/Dilaudid for breakthrough: Standard regimen
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Desired opioids
|
2
|
0
|
Baseline Characteristics
Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery
Baseline characteristics by cohort
| Measure |
ICE T
n=30 Participants
• At the end of surgery patients receive 30mg of IV ketorolac.
Once out of PACU patients receive:
* ICE PACKS applied to the perineum Q2h for 20 minutes ATC until discharge
* Ketorolac 30mg IV Q6h ATC until discharge
* Acetaminophen 1g PO Q6h ATC until discharge
* Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain
* Patients are discharged home with:
1. Acetaminophen 1 gram PO every 6 hours PRN pain 1-5 #60
2. Ketorolac 10mg PO every 6 hours PRN pain #6-10 #16
|
STANDARD
n=33 Participants
• At the end of surgery patients receive 30mg of IV ketorolac.
Once out of PACU patients receive:
* Ibuprofen 600mg PO Q4h PRN pain 1-3
* Acetaminophen/oxycodone 5mg/325mg 1 tablet PO Q4-6h PRN pain 4-6
* Acetaminophen/oxycodone 5mg/325mg 2 tablets PO Q4-6h PRN pain 7-10
* Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain
* Patients are discharged home with:
1. Ibuprofen 600mg PO Q8h PRN pain 1-5 #60
2. Acetaminophen/oxycodone 5mg/325mg 1-2 tablets Q4-6h PRN pain 6-10 #16
|
Total
n=63 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
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
60.7 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
33 participants
n=7 Participants
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visual Analog Scores (VAS) Score in the morning of post op day 1 at 7am.Visual Analog Scores (VAS) Scores in the morning of post op day 1. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm.
Outcome measures
| Measure |
ICE T
n=30 Participants
1. ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.
2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with PO Tylenol and PO toradol PRN.
Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough
|
Standard
n=33 Participants
1. Motrin 600mg PO Q4h PRN pain 1-3
2. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain
3. Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Motrin/Percocet/Dilaudid for breakthrough: Standard regimen
|
|---|---|---|
|
Visual Analog Scores (VAS)
|
20 mm
Interval 10.0 to 20.0
|
40 mm
Interval 20.0 to 50.0
|
SECONDARY outcome
Timeframe: VAS Scores at 4 hours post surgeryVAS Scores at 4 hours post surgery. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm.
Outcome measures
| Measure |
ICE T
n=30 Participants
1. ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.
2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with PO Tylenol and PO toradol PRN.
Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough
|
Standard
n=33 Participants
1. Motrin 600mg PO Q4h PRN pain 1-3
2. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain
3. Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Motrin/Percocet/Dilaudid for breakthrough: Standard regimen
|
|---|---|---|
|
VAS Scores at 4 Hours Post Surgery
|
35 mm
Interval 0.0 to 70.0
|
50 mm
Interval 30.0 to 80.0
|
SECONDARY outcome
Timeframe: VAS Scores 96 hours after surgeryVAS Scores 96 hours after surgery. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm.
Outcome measures
| Measure |
ICE T
n=30 Participants
1. ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.
2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with PO Tylenol and PO toradol PRN.
Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough
|
Standard
n=33 Participants
1. Motrin 600mg PO Q4h PRN pain 1-3
2. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain
3. Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Motrin/Percocet/Dilaudid for breakthrough: Standard regimen
|
|---|---|---|
|
VAS Scores 96 Hours After Surgery
|
20 mm
Interval 0.0 to 30.0
|
30 mm
Interval 15.0 to 50.0
|
SECONDARY outcome
Timeframe: Quality of Recovery scores on post op day 1Quality of Recovery scores on post op day 1. The QoR-40 is a 40-item quality of recovery score measuring 5 dimensions: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is rated on a 5-point Likert scale. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). It was specifically designed to measure a patient's health status after surgery and anesthesia, and it has been proposed as a measure of outcome in clinical trials.
Outcome measures
| Measure |
ICE T
n=30 Participants
1. ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.
2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with PO Tylenol and PO toradol PRN.
Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough
|
Standard
n=33 Participants
1. Motrin 600mg PO Q4h PRN pain 1-3
2. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain
3. Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Motrin/Percocet/Dilaudid for breakthrough: Standard regimen
|
|---|---|---|
|
Quality of Recovery Scores on Post op Day 1
|
182 score on a scale
Interval 158.0 to 189.0
|
173 score on a scale
Interval 164.0 to 182.0
|
SECONDARY outcome
Timeframe: Satisfaction scores in the morning after surgery (7AM)Satisfaction scores in the morning after surgery (7AM). The satisfaction score is a numerical score from 0-10 with a score of 0 indicating very dissatisfied on the left of the scale and 10 indicating very satisfied on the right of the scale.
Outcome measures
| Measure |
ICE T
n=30 Participants
1. ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.
2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with PO Tylenol and PO toradol PRN.
Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough
|
Standard
n=33 Participants
1. Motrin 600mg PO Q4h PRN pain 1-3
2. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain
3. Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Motrin/Percocet/Dilaudid for breakthrough: Standard regimen
|
|---|---|---|
|
Satisfaction Scores in the Morning After Surgery (7AM)
|
10 score on a scale
Interval 8.0 to 10.0
|
10 score on a scale
Interval 8.0 to 10.0
|
SECONDARY outcome
Timeframe: Satisfaction scores 96 hours after surgerySatisfaction scores 96 hours after surgery. The satisfaction score is a numerical score from 0-10 with a score of 0 indicating very dissatisfied on the left of the scale and 10 indicating very satisfied on the right of the scale.
Outcome measures
| Measure |
ICE T
n=30 Participants
1. ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.
2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with PO Tylenol and PO toradol PRN.
Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough
|
Standard
n=33 Participants
1. Motrin 600mg PO Q4h PRN pain 1-3
2. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain
3. Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Motrin/Percocet/Dilaudid for breakthrough: Standard regimen
|
|---|---|---|
|
Satisfaction Scores 96 Hours After Surgery
|
10 score on a scale
Interval 8.5 to 10.0
|
9 score on a scale
Interval 8.0 to 10.0
|
SECONDARY outcome
Timeframe: Time from end of surgery to discharge home from hospital, assessed up to 1 week.Length of time from the end of surgery to discharge home from the hospital, assessed up to 1 week.
Outcome measures
| Measure |
ICE T
n=30 Participants
1. ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.
2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with PO Tylenol and PO toradol PRN.
Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough
|
Standard
n=33 Participants
1. Motrin 600mg PO Q4h PRN pain 1-3
2. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain
3. Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Motrin/Percocet/Dilaudid for breakthrough: Standard regimen
|
|---|---|---|
|
Length of Stay
|
24.1 hours
Standard Deviation 3.1
|
24.1 hours
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Total dose of opioids administered during hospitalization in morphine equivalents from the end of surgery to discharge up to 1 weekTotal dose of opioids administered during hospitalization in morphine equivalents upon hospital discharge.
Outcome measures
| Measure |
ICE T
n=30 Participants
1. ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.
2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with PO Tylenol and PO toradol PRN.
Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough
|
Standard
n=33 Participants
1. Motrin 600mg PO Q4h PRN pain 1-3
2. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain
3. Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Motrin/Percocet/Dilaudid for breakthrough: Standard regimen
|
|---|---|---|
|
Total Dose of Opioids Administered During Hospitalization
|
55.7 milligrams of oral morphine equivalents
Standard Deviation 31.2
|
91.2 milligrams of oral morphine equivalents
Standard Deviation 38.9
|
SECONDARY outcome
Timeframe: Postoperative nausea and vomiting from the time to end of surgery until 7AM after surgeryNumber of patients with postoperative nausea and vomiting at 7AM after surgery
Outcome measures
| Measure |
ICE T
n=30 Participants
1. ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.
2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with PO Tylenol and PO toradol PRN.
Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough
|
Standard
n=33 Participants
1. Motrin 600mg PO Q4h PRN pain 1-3
2. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain
3. Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Motrin/Percocet/Dilaudid for breakthrough: Standard regimen
|
|---|---|---|
|
Postoperative Nausea and Vomiting at 7AM After Surgery
|
14 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Number of participants with urinary retention (discharge home with foley) measured on day patient is discharged home/study completion up to 1 week.Number of participants with urinary retention (discharge home with foley)
Outcome measures
| Measure |
ICE T
n=30 Participants
1. ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.
2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with PO Tylenol and PO toradol PRN.
Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough
|
Standard
n=33 Participants
1. Motrin 600mg PO Q4h PRN pain 1-3
2. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain
3. Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Motrin/Percocet/Dilaudid for breakthrough: Standard regimen
|
|---|---|---|
|
Number of Participants With Urinary Retention.
|
5 Participants
|
7 Participants
|
Adverse Events
ICE T
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Andrey Petrikovets MD
UH Hospitals Cleveland Medical Center/MetroHealth Medical Center at time of study protocol
Phone: 323 243 9091
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place