Trial Outcomes & Findings for Safety and Tolerability of Buprenorphine/Naloxone Film Strips (NCT NCT00640835)
NCT ID: NCT00640835
Last Updated: 2012-11-12
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
382 participants
Primary outcome timeframe
12 weeks
Results posted on
2012-11-12
Participant Flow
Patient enrollment commenced 02/28/08 and was completed 04/15/08. All sites were medical clinics.
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.
Participant milestones
| Measure |
Buprenorphine/Naloxone Film Strip Administered Sublingually
|
Buprenorphine/Naloxone Film Strip Administered Buccally
|
|---|---|---|
|
Overall Study
STARTED
|
194
|
188
|
|
Overall Study
COMPLETED
|
118
|
131
|
|
Overall Study
NOT COMPLETED
|
76
|
57
|
Reasons for withdrawal
| Measure |
Buprenorphine/Naloxone Film Strip Administered Sublingually
|
Buprenorphine/Naloxone Film Strip Administered Buccally
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
12
|
14
|
|
Overall Study
Physician Decision
|
10
|
14
|
|
Overall Study
Sponsor's Decision
|
11
|
7
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
17
|
13
|
|
Overall Study
Other Reason
|
19
|
4
|
Baseline Characteristics
Safety and Tolerability of Buprenorphine/Naloxone Film Strips
Baseline characteristics by cohort
| Measure |
Buprenorphine/Naloxone Film Strip Administered Sublingually
n=194 Participants
|
Buprenorphine/Naloxone Film Strip Administered Buccally
n=188 Participants
|
Total
n=382 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
36.1 years
STANDARD_DEVIATION 10.19 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 10.09 • n=7 Participants
|
36.4 years
STANDARD_DEVIATION 10.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
194 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
382 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
192 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
379 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
194 participants
n=5 Participants
|
188 participants
n=7 Participants
|
382 participants
n=5 Participants
|
|
Age Categorical
<21
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age Categorical
21 - 35
|
102 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Age Categorical
36 - 50
|
71 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Age Categorical
>50
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Severity Grading of Oral Mucosa
Grade 0
|
192 Participants
n=5 Participants
|
185 Participants
n=7 Participants
|
377 Participants
n=5 Participants
|
|
Severity Grading of Oral Mucosa
Grade 1
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Severity Grading of Oral Mucosa
Grade 2
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Severity Grading of Oral Mucosa
Grade 3
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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.
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
Outcome measures
| Measure |
Buprenorphine/Naloxone Film Strip Administered Sublingually
n=194 Participants
|
Buprenorphine/Naloxone Film Strip Administered Buccally
n=188 Participants
|
|---|---|---|
|
Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity.
|
11 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 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.
Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment.
Outcome measures
| Measure |
Buprenorphine/Naloxone Film Strip Administered Sublingually
n=194 Participants
|
Buprenorphine/Naloxone Film Strip Administered Buccally
n=188 Participants
|
|---|---|---|
|
Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity
Mild
|
9 Participants
|
12 Participants
|
|
Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity
Moderate
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity
Severe
|
0 Participants
|
1 Participants
|
Adverse Events
Buprenorphine/Naloxone Film Strip Administered Sublingually
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Buprenorphine/Naloxone Film Strip Administered Buccally
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Buprenorphine/Naloxone Film Strip Administered Sublingually
n=194 participants at risk
|
Buprenorphine/Naloxone Film Strip Administered Buccally
n=188 participants at risk
|
|---|---|---|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/194 • 12 weeks
|
0.53%
1/188 • 12 weeks
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.52%
1/194 • 12 weeks
|
0.00%
0/188 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/194 • 12 weeks
|
0.53%
1/188 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.52%
1/194 • 12 weeks
|
0.00%
0/188 • 12 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.52%
1/194 • 12 weeks
|
0.00%
0/188 • 12 weeks
|
|
Nervous system disorders
Syncope vasovagal
|
0.52%
1/194 • 12 weeks
|
0.00%
0/188 • 12 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.52%
1/194 • 12 weeks
|
0.00%
0/188 • 12 weeks
|
Other adverse events
| Measure |
Buprenorphine/Naloxone Film Strip Administered Sublingually
n=194 participants at risk
|
Buprenorphine/Naloxone Film Strip Administered Buccally
n=188 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Oral mucosal erythema
|
1.0%
2/194 • 12 weeks
|
3.2%
6/188 • 12 weeks
|
|
Gastrointestinal disorders
Toothache
|
1.0%
2/194 • 12 weeks
|
2.1%
4/188 • 12 weeks
|
|
Infections and infestations
Sinusitis
|
1.5%
3/194 • 12 weeks
|
2.1%
4/188 • 12 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
4/194 • 12 weeks
|
1.1%
2/188 • 12 weeks
|
Additional Information
Rolley E. Johnson, PharmD, Vice President, Clinical, Scientific and Regulatory Affairs
Reckitt Benckiser Pharmaceuticals, Inc.
Phone: 804-379-1090
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER