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Trial record 82 of 186 for:    BUPRENORPHINE AND NALOXONE

An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects

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ClinicalTrials.gov Identifier: NCT01666119
Recruitment Status : Completed
First Posted : August 16, 2012
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
BioDelivery Sciences International

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Opioid Dependence
Intervention Drug: BEMA Buprenorphine NX films
Enrollment 249
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BEMA Buprenorphine NX Films
Hide Arm/Group Description

BEMA Buprenorphine/NX films (3.5/0.6, 5.25/0.9, 7/1.2, 10.5/1.8, and 14/2.4 mg).

BEMA Buprenorphine/NX films (3.5/0.6, 5.25/0.9, 7/1.2, 10.5/1.8, and 14/2.4 mg).

Period Title: Overall Study
Started 249
Completed 197
Not Completed 52
Reason Not Completed
Adverse Event             6
Withdrawal by Subject             16
Lost to Follow-up             7
non compliance with study medication, pa             18
Subject experiencing withdrawal symptoms             5
Arm/Group Title BEMA Buprenorphine NX Films
Hide Arm/Group Description

BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively.

BEMA Buprenorphine NX films: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively.

Overall Number of Baseline Participants 249
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 249 participants
38.7  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 249 participants
Female
85
  34.1%
Male
164
  65.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 249 participants
249
1.Primary Outcome
Title Adverse Events
Hide Description Adverse events that occur in more than 2 subjects. Among the adverse events that occurred in > 2 subjects, the total number of unique events that were experienced are reported.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least 1 dose of study drug.
Arm/Group Title BEMA Buprenorphine/NX Films
Hide Arm/Group Description:
BEMA Buprenorphine/NX films (3.5/0.6mg, 5.25/0.9mg, 7.0/1.2mg, 10.5/1.7mg, 14.0/2.3mg)
Overall Number of Participants Analyzed 249
Measure Type: Number
Unit of Measure: adverse events
36
2.Secondary Outcome
Title Urine Drug Screen
Hide Description Urine samples collected at screening and baseline to test for the presence of non-prescribed opioids.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with at least one urine drug screen test during the treatment period.
Arm/Group Title BEMA Buprenorphine/NX Films
Hide Arm/Group Description:
BEMA Buprenorphine/NX films (3.5/0.6mg, 5.25/0.9mg, 7.0/1.2mg, 10.5/1.7mg, 14.0/2.3mg)
Overall Number of Participants Analyzed 249
Measure Type: Number
Unit of Measure: participants
Subjects with +-result for non-prescribed opiod 19
Number with single positive result 11
Number with 2 positive results 4
Number with > 2 positive results 4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BEMA Buprenorphine NX Films
Hide Arm/Group Description

BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively.

BEMA Buprenorphine NX films: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively.

All-Cause Mortality
BEMA Buprenorphine NX Films
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
BEMA Buprenorphine NX Films
Affected / at Risk (%) # Events
Total   1/249 (0.40%)    
Infections and infestations   
osteomyelitis * 1  1/249 (0.40%)  1
Psychiatric disorders   
suicidal ideation * 1  1/249 (0.40%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Medra
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BEMA Buprenorphine NX Films
Affected / at Risk (%) # Events
Total   89/249 (35.74%)    
General disorders   
drug withdrawal syndrome * 1  89/249 (35.74%)  89
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Medra
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Enoch Bortey
Organization: BDSI
Phone: 919 582 9050
EMail: ebortey@bdsi.com
Layout table for additonal information
Responsible Party: BioDelivery Sciences International
ClinicalTrials.gov Identifier: NCT01666119     History of Changes
Other Study ID Numbers: BNX-201
First Submitted: August 13, 2012
First Posted: August 16, 2012
Results First Submitted: February 2, 2015
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017