OARS-Pilot: Opioid Analgesic Reduction Study (OARS) - Pilot

• Sponsor: Rutgers, The State University of New Jersey (Other)
• Overall Status: Completed
• CT.gov ID: NCT05283499
• Collaborator: University of Illinois at Chicago (Other), University of Maryland, Baltimore (Other), University of Michigan (Other), University of Rochester (Other)
• Enrollment: 53
• Locations: 5
• Arms: 2
• Actual Duration (Months): 8.6
• Patients Per Site: 10.6
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The purpose of this study is to test protocols being developed for the conduct of a large sale multi-site clinical trial which will compare opioids to non-opioids for managing post-surgical impacted 3rd molar extraction pain.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Drug: OPIOID; Drug: NON-OPIOID	Phase 3

Detailed Description

A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Analgesic is formulate in capsules. Both OPIOID and NON-OPIOID analgesic formulas are packaged in the same capsules
• Primary Purpose: Supportive Care
• Official Title: Opioid Analgesic Reduction Study (OARS) - Pilot
• Actual Study Start Date: Jul 6, 2020
• Actual Primary Completion Date: Mar 12, 2021
• Actual Study Completion Date: Mar 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Opioid Combination analgesic of hydrocodone 5mg/acetaminophen350 mg	Drug: OPIOID; Analgesic assignment; Other Names: Opioid containing analgesic
Active Comparator: Non-Opioid Combination analgesic of ibuprofen 400mgacademinophen 350mg	Drug: NON-OPIOID; Analgesic assignment; Other Names: Non-opioid contains analgesic

Outcome Measures

Primary Outcome Measures

1. Pain Level [1st day]

   Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain imaginable)

2. Pain Level [Average for the 1st and 2nd day]

   Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain

3. Pain Level [Average for the first seven days post surgery]

   Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain

Secondary Outcome Measures

1. Sleep Quality [1st night]

   Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)

2. Sleep Quality [Average for the 1st and 2nd night]

   Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)

3. Sleep Quality [Average for the 1st, 2nd and 3rd night]

   Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)

4. Sleep Quality [Average for the first seven nights post surgery]

   Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)

5. Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) [1st day]

   Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always) The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others? Minimum = 6, Maximum = 30; lower is better and higher is worse outcome

6. Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) [Average for the 1st and 2nd day]

   Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always) The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others? Minimum = 6, Maximum = 30; lower is better and higher is worse outcome

7. Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) [Average for the 1st, 2nd and 3rd day]

   Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always) The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others? Minimum = 6, Maximum = 30; lower is better and higher is worse outcome

8. Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) [Average for the first seven days post surgery]

   Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always) The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others? Minimum = 6, Maximum = 30; lower is better and higher is worse outcome

9. Overall Satisfaction [Average for the first seven days post surgery]

   Subject's rating of overall satisfaction with the analgesic provided after surgery on a 5 point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adult men and non-pregnant women who are at least 18 years of age, who are able to refrain from driving or operating heavy machinery while taking the study medication will be able to participate.

• Subjects who are English speaking and are able to provide consent will be considered.

• Subjects must be in generally good health and able to take ibuprofen, paracetamol (acetaminophen), and hydrocodone.

Exclusion Criteria:

Subjects who self-report the following history will be excluded from participating:

• Individual under the age of 18

• History of gastrointestinal bleeding and/or peptic ulcer

• History of renal disease (excluding kidney stones)

• History of hepatic disease

• History of bleeding disorder

• History of respiratory depression

• Any prior respiratory effect of an opioid or other anesthetic drug that required respiratory support postoperatively

• Active or untreated asthma

• History of known allergic reaction to ibuprofen, acetaminophen, hydrocodone, and/or anesthesia

• Currently taking any of the following medications:

• CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), which may increase plasma concentrations of hydrocodone bitartrate and acetaminophen and prolong opioid adverse reactions, and which may cause potentially fatal respiratory depression

• CNS depressants.

• Consumes 3 or more alcoholic drinks every day and/or has a history of alcoholism

• History of drug or alcohol abuse (excludes marijuana use)

• Family history of drug or alcohol abuse in a first degree relative

• Has had one or more opioid prescription filled within the past 6 months

• Currently pregnant or lactating

Patients would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes:

• Prior participation in this study

• Inability or refusal to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois Chicago	Chicago	Illinois	United States	60607
2	University of Maryland	Baltimore	Maryland	United States	21201
3	University of Michigan	Ann Arbor	Michigan	United States	48109
4	Rutgers University	Newark	New Jersey	United States	07103
5	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

• Rutgers, The State University of New Jersey
• University of Illinois at Chicago
• University of Maryland, Baltimore
• University of Michigan
• University of Rochester

Investigators

• Study Director: Janine Fredericks-Younger, DMD, Rutgers School of Dental Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 28, 2021
• Informed Consent Form - Jan 9, 2020

More Information

Publications

None provided.

• Responsible Party: Cecile A. Feldman, DMD, Professor and Dean, Rutgers School of dental Medicine, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT05283499
• Other Study ID Numbers: Pro2020001891
• First Posted: Mar 17, 2022
• Last Update Posted: Jul 13, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Cecile A. Feldman, DMD, Professor and Dean, Rutgers School of dental Medicine, Rutgers, The State University of New Jersey: Opioids; Pain Management; Analgesics
• Additional relevant MeSH terms: Pain, Postoperative; Analgesics, Opioid; Analgesics; Analgesics, Non-Narcotic

Study Results

Participant Flow

Arm/Group Title	Opioid	Non-Opioid
Arm/Group Description	Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Period Title: Overall Study
STARTED	26	27
COMPLETED	25	25
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Opioid	Non-Opioid	Total
Arm/Group Description	Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment	Total of all reporting groups
Overall Participants	25	25	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	25 100%	25 100%	50 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	12 48%	13 52%	25 50%
Male	13 52%	12 48%	25 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 24%	7 28%	13 26%
Not Hispanic or Latino	19 76%	18 72%	37 74%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	4 16%	3 12%	7 14%
Native Hawaiian or Other Pacific Islander	0 0%	1 4%	1 2%
Black or African American	10 40%	7 28%	17 34%
White	3 12%	11 44%	14 28%
More than one race	3 12%	1 4%	4 8%
Unknown or Not Reported	5 20%	2 8%	7 14%
Region of Enrollment (participants) [Number]
United States	25 100%	25 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	Pain Level
Description	Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain imaginable)
Time Frame	1st day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Opioid	Non-Opioid
Arm/Group Description	Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Measure Participants	25	25
Mean (Standard Error) [score on a scale]	5.67 (0.59)	4.09 (0.59)

2. Primary Outcome

Title	Pain Level
Description	Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain
Time Frame	Average for the 1st and 2nd day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Opioid	Non-Opioid
Arm/Group Description	Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Measure Participants	25	25
Mean (Standard Error) [score on a scale]	5.10 (0.58)	3.57 (0.58)

3. Primary Outcome

Title	Pain Level
Description	Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain
Time Frame	Average for the first seven days post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Opioid	Non-Opioid
Arm/Group Description	Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Measure Participants	25	25
Mean (Standard Error) [score on a scale]	4.00 (0.54)	2.74 (0.54)

4. Secondary Outcome

Title	Sleep Quality
Description	Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)
Time Frame	1st night

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Opioid	Non-Opioid
Arm/Group Description	Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Measure Participants	25	25
Mean (Standard Error) [score on a scale]	5.45 (0.69)	3.76 (0.70)

5. Secondary Outcome

Title	Sleep Quality
Description	Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)
Time Frame	Average for the 1st and 2nd night

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Opioid	Non-Opioid
Arm/Group Description	Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Measure Participants	25	25
Mean (Standard Error) [score on a scale]	5.25 (0.64)	3.44 (0.65)

6. Secondary Outcome

Title	Sleep Quality
Description	Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)
Time Frame	Average for the 1st, 2nd and 3rd night

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Opioid	Non-Opioid
Arm/Group Description	Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Measure Participants	25	25
Mean (Standard Error) [score on a scale]	4.91 (0.63)	3.36 (0.63)

7. Secondary Outcome

Title	Sleep Quality
Description	Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)
Time Frame	Average for the first seven nights post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Opioid	Non-Opioid
Arm/Group Description	Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Measure Participants	25	25
Mean (Standard Error) [score on a scale]	4.38 (0.60)	2.89 (0.60)

8. Secondary Outcome

Title	Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Description	Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always) The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others? Minimum = 6, Maximum = 30; lower is better and higher is worse outcome
Time Frame	1st day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Opioid	Non-Opioid
Arm/Group Description	Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Measure Participants	25	25
Mean (Standard Error) [score on a scale]	17.62 (1.27)	14.34 (1.26)

9. Secondary Outcome

Title	Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Description	Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always) The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others? Minimum = 6, Maximum = 30; lower is better and higher is worse outcome
Time Frame	Average for the 1st and 2nd day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Opioid	Non-Opioid
Arm/Group Description	Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Measure Participants	25	25
Mean (Standard Error) [score on a scale]	16.21 (1.18)	12.91 (1.19)

10. Secondary Outcome

Title	Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Description	Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always) The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others? Minimum = 6, Maximum = 30; lower is better and higher is worse outcome
Time Frame	Average for the 1st, 2nd and 3rd day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Opioid	Non-Opioid
Arm/Group Description	Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Measure Participants	25	25
Mean (Standard Error) [score on a scale]	15.50 (1.15)	12.19 (1.16)

11. Secondary Outcome

Title	Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Description	Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always) The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others? Minimum = 6, Maximum = 30; lower is better and higher is worse outcome
Time Frame	Average for the first seven days post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Opioid	Non-Opioid
Arm/Group Description	Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Measure Participants	25	25
Mean (Standard Error) [score on a scale]	13.74 (1.12)	11.01 (1.13)

12. Secondary Outcome

Title	Overall Satisfaction
Description	Subject's rating of overall satisfaction with the analgesic provided after surgery on a 5 point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied)
Time Frame	Average for the first seven days post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Opioid	Non-Opioid
Arm/Group Description	Combination analgesic of hydrocodone 5mg/acetaminophen350 mg OPIOID: Analgesic assignment	Combination analgesic of ibuprofen 400mgacademinophen 350mg NON-OPIOID: Analgesic assignment
Measure Participants	25	25
Mean (Standard Deviation) [score on a scale]	2.1 (1.4)	1.7 (0.89)

Adverse Events

Time Frame	Post-operative Period -- 9 Days +/- 5 days from surgery
Adverse Event Reporting Description	Adverse event is defined as an event which required a unexpected office visit or visit to an emergency room and could be related to study intervention
Arm/Group Title	OPIOID		NON-OPIOID
Arm/Group Description	Received hydrocodone/acetaminophen		Received ibuprofen/acetaminophen
All Cause Mortality
	OPIOID		NON-OPIOID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Serious Adverse Events
	OPIOID		NON-OPIOID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	OPIOID		NON-OPIOID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/25 (4%)		0/25 (0%)
Gastrointestinal disorders
Constipation	1/25 (4%)	1	0/25 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.