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Trial record 13 of 186 for:    BUPRENORPHINE AND NALOXONE

Safety and Tolerability of Buprenorphine/Naloxone Film Strips

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00640835
Recruitment Status : Completed
First Posted : March 21, 2008
Results First Posted : October 26, 2010
Last Update Posted : November 12, 2012
Sponsor:
Information provided by (Responsible Party):
Indivior Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Opioid-Related Disorders
Intervention Drug: Buprenorphine/naloxone Film Strip
Enrollment 382
Recruitment Details Patient enrollment commenced 02/28/08 and was completed 04/15/08. All sites were medical clinics.
Pre-assignment Details Subjects were required to be on a stabilized dose of buprenorphine and naloxone for at least 30 days prior to study drug administration, either during the screening period, or as part of routine medical treatment during the previous 30 days.
Arm/Group Title Buprenorphine/Naloxone Film Strip Administered Sublingually Buprenorphine/Naloxone Film Strip Administered Buccally
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 194 188
Completed 118 131
Not Completed 76 57
Reason Not Completed
Adverse Event             5             3
Withdrawal by Subject             12             14
Physician Decision             10             14
Sponsor's Decision             11             7
Protocol Violation             2             2
Lost to Follow-up             17             13
Other Reason             19             4
Arm/Group Title Buprenorphine/Naloxone Film Strip Administered Sublingually Buprenorphine/Naloxone Film Strip Administered Buccally Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 194 188 382
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 194 participants 188 participants 382 participants
36.1  (10.19) 36.7  (10.09) 36.4  (10.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 188 participants 382 participants
Female
70
  36.1%
72
  38.3%
142
  37.2%
Male
124
  63.9%
116
  61.7%
240
  62.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 188 participants 382 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
194
 100.0%
188
 100.0%
382
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 188 participants 382 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.5%
0
   0.0%
1
   0.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   0.5%
1
   0.5%
2
   0.5%
White
192
  99.0%
187
  99.5%
379
  99.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 194 participants 188 participants 382 participants
194 188 382
Age Categorical   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 194 participants 188 participants 382 participants
<21 4 0 4
21 - 35 102 99 201
36 - 50 71 67 138
>50 17 22 39
[1]
Measure Description: The age categories used for this study were slightly different than the standard values and are reflected as reported in the study.
Severity Grading of Oral Mucosa   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 194 participants 188 participants 382 participants
Grade 0 192 185 377
Grade 1 2 1 3
Grade 2 0 1 1
Grade 3 0 1 1
[1]
Measure Description:

Safety and tolerability were evaluated at baseline by oral cavity examination. Oral mucosa was graded as follows:

Grade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs

1.Primary Outcome
Title Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity.
Hide Description

Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. Oral mucosa was graded as follows:

Grade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The population was defined as all subjects who received at least a single dose of study drug and was the only population considered in the analysis plan. Missing data values were not imputed.
Arm/Group Title Buprenorphine/Naloxone Film Strip Administered Sublingually Buprenorphine/Naloxone Film Strip Administered Buccally
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 194 188
Measure Type: Number
Unit of Measure: Participants
11 16
2.Primary Outcome
Title Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity
Hide Description Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The population was defined as all subjects who received at least a single dose of study drug and was the only population considered in the analysis plan. Missing data values were not imputed.
Arm/Group Title Buprenorphine/Naloxone Film Strip Administered Sublingually Buprenorphine/Naloxone Film Strip Administered Buccally
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 194 188
Measure Type: Number
Unit of Measure: Participants
Mild 9 12
Moderate 2 3
Severe 0 1
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Buprenorphine/Naloxone Film Strip Administered Sublingually Buprenorphine/Naloxone Film Strip Administered Buccally
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Buprenorphine/Naloxone Film Strip Administered Sublingually Buprenorphine/Naloxone Film Strip Administered Buccally
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Buprenorphine/Naloxone Film Strip Administered Sublingually Buprenorphine/Naloxone Film Strip Administered Buccally
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/194 (2.06%)      2/188 (1.06%)    
Blood and lymphatic system disorders     
Anaemia  1  1/194 (0.52%)  0/188 (0.00%)  0
Injury, poisoning and procedural complications     
Road traffic accident  1  0/194 (0.00%)  0 1/188 (0.53%) 
Skin injury  1  1/194 (0.52%)  0/188 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Oesophageal carcinoma  1  0/194 (0.00%)  0 1/188 (0.53%) 
Squamous cell carcinoma of the cervix  1  1/194 (0.52%)  0/188 (0.00%)  0
Nervous system disorders     
Syncope vasovagal  1  1/194 (0.52%)  0/188 (0.00%)  0
Renal and urinary disorders     
Nephrolithiasis  1  1/194 (0.52%)  0/188 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Buprenorphine/Naloxone Film Strip Administered Sublingually Buprenorphine/Naloxone Film Strip Administered Buccally
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/194 (5.67%)      16/188 (8.51%)    
Gastrointestinal disorders     
Oral mucosal erythema  1  2/194 (1.03%)  6/188 (3.19%) 
Toothache  1  2/194 (1.03%)  4/188 (2.13%) 
Infections and infestations     
Sinusitis  1  3/194 (1.55%)  4/188 (2.13%) 
Upper respiratory tract infection  1  4/194 (2.06%)  2/188 (1.06%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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
Layout table for Results Point of Contact information
Name/Title: Rolley E. Johnson, PharmD, Vice President, Clinical, Scientific and Regulatory Affairs
Organization: Reckitt Benckiser Pharmaceuticals, Inc.
Phone: 804-379-1090 ext 7089
EMail: ed.johnson@reckittbenckiser.com
Layout table for additonal information
Responsible Party: Indivior Inc.
ClinicalTrials.gov Identifier: NCT00640835     History of Changes
Other Study ID Numbers: RB-US-07-0001
First Submitted: March 14, 2008
First Posted: March 21, 2008
Results First Submitted: September 30, 2010
Results First Posted: October 26, 2010
Last Update Posted: November 12, 2012