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Trial record 57 of 531 for:    Taste Disorders

Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population

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ClinicalTrials.gov Identifier: NCT02038790
Recruitment Status : Completed
First Posted : January 17, 2014
Results First Posted : March 21, 2017
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Indivior Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Opioid Dependence
Interventions Drug: Suboxone Sublingual Film
Drug: Zubsolv sublingual tablets
Enrollment 33
Recruitment Details  
Pre-assignment Details Thirty nine (39) subjects were screened and thirty three (33) subjects were enrolled in the study.
Arm/Group Title Suboxone - Zubsolv Zubsolv - Suboxone
Hide Arm/Group Description Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1. Participants received Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 0 and Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 1.
Period Title: Day 0 - First Treatment
Started 16 17
Completed 15 16
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Period Title: Day 1 - Second Treatment
Started 15 16
Completed 15 16
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
All treated participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
38  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
14
  42.4%
Male
19
  57.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Hispanic or Latino
4
  12.1%
Not Hispanic or Latino
29
  87.9%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 33 participants
33
1.Primary Outcome
Title Overall Intervention Preference As Assessed by Participants
Hide Description At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: When thinking about the two medications you evaluated over the last two days, which medication type did you prefer?
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: percentage of participants
Suboxone 54.84
Zubsolv 45.16
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.5000
Comments Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Participant Preference With Regard to Overall Taste of Interventions
Hide Description At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: Which one did you prefer in regards to overall taste?
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: percentage of participants
Suboxone 29.03
Zubsolv 70.97
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0196
Comments Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Participant Assessments With Regard to Ease of Dissolution of Interventions
Hide Description At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: Which one did you think dissolve easier in your mouth?
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: percentage of participants
Suboxone 19.35
Zubsolv 80.65
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package?
Hide Description Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.
Time Frame Days 0-1
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Arm/Group Title Suboxone Sublingual Film 8/2 Zubsolv Sublingual Tablets 5.7/1.4
Hide Arm/Group Description:
Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Overall Number of Participants Analyzed 31 31
Measure Type: Number
Unit of Measure: percentage of participants
Favorable response 61.29 51.61
Unfavorable response 38.71 48.39
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Suboxone Sublingual Film 8/2, Zubsolv Sublingual Tablets 5.7/1.4
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4422
Comments Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow?
Hide Description Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.
Time Frame Days 0-1
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Arm/Group Title Suboxone Sublingual Film 8/2 Zubsolv Sublingual Tablets 5.7/1.4
Hide Arm/Group Description:
Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: percentage of participants
Favorable response 100 90.32
Unfavorable response 0 9.68
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Suboxone Sublingual Film 8/2, Zubsolv Sublingual Tablets 5.7/1.4
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2377
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth?
Hide Description Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.
Time Frame Days 0-1
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Arm/Group Title Suboxone Sublingual Film 8/2 Zubsolv Sublingual Tablets 5.7/1.4
Hide Arm/Group Description:
Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Overall Number of Participants Analyzed 31 31
Measure Type: Number
Unit of Measure: percentage of participants
Favorable response 54.84 77.42
Unfavorable response 45.16 22.58
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Suboxone Sublingual Film 8/2, Zubsolv Sublingual Tablets 5.7/1.4
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0603
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth?
Hide Description Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.
Time Frame Days 0-1
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Arm/Group Title Suboxone Sublingual Film 8/2 Zubsolv Sublingual Tablets 5.7/1.4
Hide Arm/Group Description:
Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Overall Number of Participants Analyzed 31 31
Measure Type: Number
Unit of Measure: percentage of participants
Favorable response 54.84 96.77
Unfavorable response 45.16 3.23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Suboxone Sublingual Film 8/2, Zubsolv Sublingual Tablets 5.7/1.4
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0010
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?
Hide Description Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme.
Time Frame Days 0-1
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Arm/Group Title Suboxone Sublingual Film 8/2 Zubsolv Sublingual Tablets 5.7/1.4
Hide Arm/Group Description:
Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Overall Number of Participants Analyzed 31 31
Measure Type: Number
Unit of Measure: percentage of participants
0 (none) 67.74 58.06
1 19.35 19.35
2 6.45 16.13
3 3.23 0
4 0 0
5 3.23 3.23
6 0 0
7 0 0
8 0 0
9 (extreme) 0 3.23
9.Secondary Outcome
Title Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?
Hide Description Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme.
Time Frame Days 0-1
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Arm/Group Title Suboxone Sublingual Film 8/2 Zubsolv Sublingual Tablets 5.7/1.4
Hide Arm/Group Description:
Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Overall Number of Participants Analyzed 31 31
Measure Type: Number
Unit of Measure: percentage of participants
0 (none) 70.97 70.97
1 22.58 29.03
2 3.23 0
3 0 0
4 0 0
5 3.23 0
6 0 0
7 0 0
8 0 0
9 (extreme) 0 0
10.Secondary Outcome
Title Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High'
Hide Description Participant responses were captured on a 10-point scale with 0 = No high and 9= Extremely strong high.
Time Frame Days 0-1
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Arm/Group Title Suboxone Sublingual Film 8/2 Zubsolv Sublingual Tablets 5.7/1.4
Hide Arm/Group Description:
Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Overall Number of Participants Analyzed 31 31
Measure Type: Number
Unit of Measure: percentage of participants
0 (no high) 70.97 61.29
1 16.13 32.26
2 9.68 6.45
3 0 0
4 0 0
5 3.23 0
6 0 0
7 0 0
8 0 0
9 (extremely strong high) 0 0
11.Secondary Outcome
Title Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication
Hide Description Participant responses were captured on a 10-point scale with 0 = No desire to abuse and 9= Extremely high desire to abuse.
Time Frame Days 0-1
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Arm/Group Title Suboxone Sublingual Film 8/2 Zubsolv Sublingual Tablets 5.7/1.4
Hide Arm/Group Description:
Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Overall Number of Participants Analyzed 31 31
Measure Type: Number
Unit of Measure: percentage of participants
0 (no high) 70.97 61.29
1 16.13 35.48
2 9.68 3.23
3 0 0
4 0 0
5 3.23 0
6 0 0
7 0 0
8 0 0
9 (extremely strong high) 0 0
12.Secondary Outcome
Title Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to......
Hide Description

Choices to the question above are:

  • Crush and snort
  • Liquefy and inject
  • Not able to abuse this formulation
Time Frame Days 0-1
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Arm/Group Title Suboxone Sublingual Film 8/2 Zubsolv Sublingual Tablets 5.7/1.4
Hide Arm/Group Description:
Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Overall Number of Participants Analyzed 31 31
Measure Type: Number
Unit of Measure: percentage of participants
Crush and snort 0 25.81
Liquefy and inject 0 3.23
Not able to abuse this formulation 100 70.97
13.Secondary Outcome
Title Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was.....
Hide Description

Choices to the question above are:

  • More effective as a treatment for opioid dependence
  • Equally effective as a treatment for opioid dependence
  • Less effective as a treatment for opioid dependence
  • The same medication that I normally use
Time Frame Days 0-1
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Arm/Group Title Suboxone Sublingual Film 8/2 Zubsolv Sublingual Tablets 5.7/1.4
Hide Arm/Group Description:
Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Overall Number of Participants Analyzed 31 31
Measure Type: Number
Unit of Measure: percentage of participants
More effective 3.23 0
Equally effective 29.03 51.61
Less effective 0 32.26
Same medication I normally use 67.74 16.13
14.Secondary Outcome
Title Dissolution Time of Intervention as Recorded by a Trained Observer
Hide Description The subject was observed and times documented for time of administration and time dissolution (recorded in minutes and seconds) was completed by designated qualified study personnel at the site.
Time Frame Days 0-1
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included participants who did not miss any visit and had no major protocol violations.
Arm/Group Title Suboxone Sublingual Film 8/2 Zubsolv Sublingual Tablets 5.7/1.4
Hide Arm/Group Description:
Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: minutes
6.59  (5.28) 2.98  (2.48)
15.Secondary Outcome
Title Change From Baseline in Subject Opiate Withdrawal Scale (SOWS)
Hide Description

Participants completed the Subject Opiate Withdrawal Scale (SOWS) at baseline, and the end of each day of treatment.

SOWS is a validated scale when used as defined. The research site did not use SOWS as defined. The sponsor made the decision to not report this data since it was not captured in a validated format.

Time Frame Day 0 prior to dosing, end of Day 0 (post dose), end of Day 1 (post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol set.
Arm/Group Title Suboxone Sublingual Film 8/2 Zubsolv Sublingual Tablets 5.7/1.4
Hide Arm/Group Description:
Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Days 0 (post treatment) -1
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Suboxone Sublingual Film 8/2 Zubsolv Sublingual Tablets 5.7/1.4
Hide Arm/Group Description Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study. Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
All-Cause Mortality
Suboxone Sublingual Film 8/2 Zubsolv Sublingual Tablets 5.7/1.4
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/32 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Suboxone Sublingual Film 8/2 Zubsolv Sublingual Tablets 5.7/1.4
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Suboxone Sublingual Film 8/2 Zubsolv Sublingual Tablets 5.7/1.4
Affected / at Risk (%) Affected / at Risk (%)
Total   3/32 (9.38%)   13/32 (40.63%) 
Gastrointestinal disorders     
Constipation  1  0/32 (0.00%)  2/32 (6.25%) 
General disorders     
Drug withdrawal syndrome  1  2/32 (6.25%)  8/32 (25.00%) 
Oedema peripheral  1  1/32 (3.13%)  0/32 (0.00%) 
Fatigue  1  0/32 (0.00%)  1/32 (3.13%) 
Nervous system disorders     
Somnolence  1  0/32 (0.00%)  1/32 (3.13%) 
Headache  1  0/32 (0.00%)  1/32 (3.13%) 
Psychiatric disorders     
Anxiety  1  0/32 (0.00%)  1/32 (3.13%) 
Agitation  1  0/32 (0.00%)  1/32 (3.13%) 
Respiratory, thoracic and mediastinal disorders     
Rhinnorhoea  1  0/32 (0.00%)  1/32 (3.13%) 
1
Term from vocabulary, MedDRA (16.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Proposed publications shall be submitted to Sponsor 30 days prior to submission for publication, and may be withheld for an additional period, up to 90 days, to allow Sponsor to file patent applications. If a multi-center publication isn't submitted for publication within 12 months of the conclusion of the Study at all sites, or is published in a shorter period, the results from the institution's site may be published individually.
Results Point of Contact
Name/Title: Global Director Clinical Development
Organization: Indivior, Inc.
Phone: 804-379-1090
Responsible Party: Indivior Inc.
ClinicalTrials.gov Identifier: NCT02038790     History of Changes
Other Study ID Numbers: RBP-OSZ1
13-131220-108 ( Other Identifier: Hill Top Research )
First Submitted: January 15, 2014
First Posted: January 17, 2014
Results First Submitted: January 31, 2017
Results First Posted: March 21, 2017
Last Update Posted: March 21, 2017