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Trial record 80 of 182 for:    ERYTHROMYCIN

Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of Buprenorphine Transdermal System (BTDS) and Ketoconazole

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: NCT01259115
Recruitment Status : Completed
First Posted : December 13, 2010
Results First Posted : January 26, 2011
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator)
Condition Healthy
Interventions Drug: Buprenorphine transdermal patch
Drug: Ketoconazole tablet
Drug: Placebo to match ketoconazole tablet
Enrollment 20
Recruitment Details 21-Oct-2002 (first subject, first visit) to 20-Jun-2003 (last subject, last visit). Study conducted at 1 site in New Orleans, LA.
Pre-assignment Details Healthy male and female subjects aged 18 to 54 years, demonstrating successful inhibition of CYP3A4 using the EBT (erythromycin breath test) probe were randomized.
Arm/Group Title Sequence A: BTDS 10 With Ketoconazole (Test) First Sequence B: BTDS 10 With Placebo (Reference) First
Hide Arm/Group Description

Period 1: Buprenorphine transdermal system (BTDS) 10 with ketoconazole 200 mg tablets twice daily (Test) first;

Washout Period of 4 to 18 days;

Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.

Period 1: Buprenorphine transdermal system (BTDS) 10 with ketoconazole placebo tablets twice daily (Reference) first

Washout Period of 4 to 18 days;

Period 2: BTDS 10 with ketoconazole 200 mg tablets twice daily.

Period Title: Period 1
Started 10 10
Completed 7 9
Not Completed 3 1
Reason Not Completed
Adverse Event             1             0
Protocol Violation             2             0
Lost to Follow-up             0             1
Period Title: Period: Washout Period of 4 to 18 Days
Started 7 9
Completed 7 9
Not Completed 0 0
Period Title: Period 2
Started 7 9
Completed 6 9
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title Overall Study
Hide Arm/Group Description Subjects received BTDS 10 with ketoconazole 200 mg or ketoconazole placebo tablets twice daily in period 1; Washout Period for 4 to 18 days; Subjects received BTDS 10 with ketoconazole 200 mg or ketoconazole placebo tablets twice daily in period 2.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
31.8  (8.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
4
  20.0%
Male
16
  80.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
14
  70.0%
White
6
  30.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title AUCt of Buprenorphine With and Without Ketoconazole.
Hide Description

AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral twice daily.

Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or Ketoconazole placebo (orally twice daily) between days 17 and 27.

Time Frame BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid pharmacokinetic metric.
Arm/Group Title BTDS 10 With Ketoconazole BTDS 10 With Ketoconazole Placebo
Hide Arm/Group Description:
Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
Overall Number of Participants Analyzed 18 16
Mean (Standard Deviation)
Unit of Measure: pg/mL*h
16354.8  (6197.3) 16627.9  (5559.7)
2.Primary Outcome
Title AUCinf of Buprenorphine With and Without Ketoconazole.
Hide Description

AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral twice daily.

Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27.

Time Frame BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid pharmacokinetic metric.
Arm/Group Title BTDS 10 With Ketoconazole BTDS 10 With Ketoconazole Placebo
Hide Arm/Group Description:
Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
Overall Number of Participants Analyzed 13 9
Mean (Standard Deviation)
Unit of Measure: pg /mL•h
18238.5  (6624.5) 19012.5  (6599.2)
3.Primary Outcome
Title Cmax of Buprenorphine With and Without Ketoconazole.
Hide Description

Cmax (maximum observed plasma concentration) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral tablets twice daily,

Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27.

Time Frame BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.
Arm/Group Title BTDS 10 With Ketoconazole BTDS 10 With Ketoconazole Placebo
Hide Arm/Group Description:
Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
Overall Number of Participants Analyzed 18 16
Mean (Standard Deviation)
Unit of Measure: pg/mL
142.2  (53.7) 145.5  (48.7)
4.Primary Outcome
Title AUCt of Nor-buprenorphine With and Without Ketoconazole
Hide Description

For nor-buprenorphine pharmacokinetic metric, AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration).

Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27.

Time Frame BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.
Arm/Group Title BTDS 10 With Ketoconazole BTDS 10 With Ketoconazole Placebo
Hide Arm/Group Description:
Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
Overall Number of Participants Analyzed 16 11
Mean (Standard Deviation)
Unit of Measure: pg/mL*h
5091.0  (3208.3) 3207.8  (1746.4)
5.Primary Outcome
Title AUCinf of Nor-buprenorphine With and Without Ketoconazole
Hide Description

For nor-buprenorphine pharmacokinetic metric, AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity).

Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27.

Time Frame BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.
Arm/Group Title BTDS 10 With Ketoconazole BTDS 10 With Ketoconazole Placebo
Hide Arm/Group Description:
Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: pg/mL*h
6767.9  (0)
6.Primary Outcome
Title Cmax of Nor-buprenorphine With and Without Ketoconazole
Hide Description

For nor-buprenorphine pharmacokinetic metric, Cmax (maximum observed plasma concentration), log transformed data were analyzed.

Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27.

Time Frame BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.
Arm/Group Title BTDS 10 With Ketoconazole BTDS 10 With Ketoconazole Placebo
Hide Arm/Group Description:
Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
Overall Number of Participants Analyzed 16 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
63.4  (25.9) 44.6  (11.1)
7.Primary Outcome
Title AUCt of Nor-buprenorphine Glucuronide With and Without Ketoconazole
Hide Description

For nor-buprenorphine glucuronide pharmacokinetic metrics, AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration), log transformed data were analyzed.

Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27.

Time Frame BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.
Arm/Group Title BTDS 10 With Ketoconazole BTDS 10 With Ketoconazole Placebo
Hide Arm/Group Description:
Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
Overall Number of Participants Analyzed 18 16
Mean (Standard Deviation)
Unit of Measure: pg/mL*h
21376.9  (9808.2) 15840.5  (5034.5)
8.Primary Outcome
Title AUCinf of Nor-buprenorphine Glucuronide With and Without Ketoconazole
Hide Description

For nor-buprenorphine glucuronide pharmacokinetic metrics, AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity) log transformed data were analyzed.

Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27.

Time Frame BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.
Arm/Group Title BTDS 10 With Ketoconazole BTDS 10 With Ketoconazole Placebo
Hide Arm/Group Description:
Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
Overall Number of Participants Analyzed 0 3
Mean (Standard Deviation)
Unit of Measure: pg/mL*h
17318.9  (657.2)
9.Primary Outcome
Title Cmax of Nor-buprenorphine Glucuronide With and Without Ketoconazole
Hide Description

For nor-buprenorphine glucuronide pharmacokinetic metric, Cmax (maximum observed plasma concentration), log transformed data were analyzed.

Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27.

Time Frame BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.
Arm/Group Title BTDS 10 With Ketoconazole BTDS 10 With Ketoconazole Placebo
Hide Arm/Group Description:
Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
Overall Number of Participants Analyzed 18 16
Mean (Standard Deviation)
Unit of Measure: pg/mL
218.2  (99.4) 141.9  (47.6)
10.Primary Outcome
Title AUCt of Buprenorphine-3-glucuronide With and Without Ketoconazole
Hide Description

For buprenorphine-3-glucuronide pharmacokinetic metric, AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration), log transformed data were analyzed.

Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27.

Time Frame BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.
Arm/Group Title BTDS 10 With Ketoconazole BTDS 10 With Ketoconazole Placebo
Hide Arm/Group Description:
BTDS 10 with ketoconazole 200 mg tablets twice daily
Buprenorphine-3-glucuronide was not measured in the plasma during treatment
Overall Number of Participants Analyzed 5 0
Mean (Standard Deviation)
Unit of Measure: pg/mL*h
342.4  (488.2)
11.Primary Outcome
Title AUCinf of Buprenorphine-3-glucuronide With and Without Ketoconazole
Hide Description

For buprenorphine-3-glucuronide pharmacokinetic metric, AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity), log transformed data were analyzed.

Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27.

Time Frame BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.
Arm/Group Title BTDS 10 With Ketoconazole BTDS 10 With Ketoconazole Placebo
Hide Arm/Group Description:
BTDS 10 with ketoconazole 200 mg tablets twice daily
Buprenorphine-3-glucuronide was not measured in the plasma during treatment
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Primary Outcome
Title Cmax of Buprenorphine-3-glucuronide With and Without Ketoconazole
Hide Description

For buprenorphine-3-glucuronide pharmacokinetic metric, Cmax (maximum observed plasma concentration), log transformed data were analyzed.

Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27.

Time Frame BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.
Arm/Group Title BTDS 10 With Ketoconazole BTDS 10 With Ketoconazole Placebo
Hide Arm/Group Description:
BTDS 10 with ketoconazole 200 mg tablets twice daily
Buprenorphine-3-glucuronide was not measured in the plasma during treatment
Overall Number of Participants Analyzed 5 0
Mean (Standard Deviation)
Unit of Measure: pg/mL
88.5  (85.6)
13.Secondary Outcome
Title CYP3A4 Inhibition by Observation of Plasma Nor-buprenorphine Production Assessed by the Erythromycin Breath Test.
Hide Description As part of subject screening, Erythromycin Breath Tests (EBT) were done on all potential subjects (enrolled population). CYP 3A4 inhibition was calculated by taking the difference of the baseline 14C erythromycin metabolism, subtracting the 14C erythromycin metabolism during ketoconazole treatment, dividing this difference by the baseline 14C erythromycin metabolism, and multiplying by 100 to express results in the form of percent inhibition. CYP3A4 inhibition was only done when subjects were on ketoconazole.
Time Frame One time at screening and one time during ketoconazole treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled Population: All subjects who participated in the study. CYP3A4 Inhibition was only done when subjects were on Ketoconazole.
Arm/Group Title All Subjects
Hide Arm/Group Description:
Subjects who received BTDS with Ketoconazole treatment
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: Percentage of participants
All subjects [N = 20] 64.49  (15.69)
Inhibition ≤ 50% [n = 4] 37.50  (4.11)
Inhibition >50% but ≤ 70% [n = 8] 64.50  (4.61)
Inhibition > 70% [n = 8] 77.98  (3.94)
14.Secondary Outcome
Title The Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Hide Description Safety assessments consisted of monitoring and recording medical history, physical examinations, vital signs (including temperature, heart rate, blood pressure and respiratory rate), reports of adverse experiences, and laboratory abnormalities (including electrocardiogram [ECG]).
Time Frame The first day of study drug administration to 30 days after the last dose of study drug.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: Safety analyses were performed on all subjects who received at least 1 dose of study drug and for whom at least 1 postdose safety observation was recorded.
Arm/Group Title BTDS 10 With Ketoconazole BTDS 10 With Ketoconazole Placebo
Hide Arm/Group Description:
Buprenorphine transdermal system (BTDS) 10 with ketoconazole 200 mg tablets twice daily.
Buprenorphine transdermal system (BTDS) 10 with ketoconazole placebo oral tablets twice daily.
Overall Number of Participants Analyzed 19 17
Measure Type: Number
Unit of Measure: participants
Deaths 0 0
Serious Adverse Events 0 0
Adverse Events in 4% or more of subjects 19 16
Time Frame All adverse events during the course of the study were collected and were to be followed until resolution or for 30 days after the last dose of study drug. Serious adverse events were followed until the event resolved or sequelae stabilized.
Adverse Event Reporting Description AEs were learned of by spontaneous reports, subject interview, and daily diary
 
Arm/Group Title BTDS With Ketoconazole BTDS With Placebo
Hide Arm/Group Description Subjects who were treated with buprenorphine transdermal patch 10 mcg/hour with ketoconazole 200 mg oral tablets twice daily. Subjects who were treated with buprenorphine transdermal patch 10 mcg/hour with ketoconazole placebo oral tablets twice daily.
All-Cause Mortality
BTDS With Ketoconazole BTDS With Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BTDS With Ketoconazole BTDS With Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
BTDS With Ketoconazole BTDS With Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   19/19 (100.00%)   16/17 (94.12%) 
Blood and lymphatic system disorders     
Ecchymosis  1  1/19 (5.26%)  0/17 (0.00%) 
Thrombocytopenia  1  1/19 (5.26%)  0/17 (0.00%) 
Eye disorders     
Dry eyes  1  0/19 (0.00%)  1/17 (5.88%) 
Photophobia  1  0/19 (0.00%)  1/17 (5.88%) 
Gastrointestinal disorders     
Cardiospasm  1  0/19 (0.00%)  1/17 (5.88%) 
Constipation  1  0/19 (0.00%)  1/17 (5.88%) 
Dyspepsia  1  1/19 (5.26%)  2/17 (11.76%) 
Dysphagia  1  1/19 (5.26%)  0/17 (0.00%) 
Nausea  1  5/19 (26.32%)  4/17 (23.53%) 
Stomatitis  1  0/19 (0.00%)  1/17 (5.88%) 
Tooth disorder  1  1/19 (5.26%)  0/17 (0.00%) 
Vomiting  1  4/19 (21.05%)  2/17 (11.76%) 
General disorders     
Abdominal pain  1  1/19 (5.26%)  1/17 (5.88%) 
Back pain  1  0/19 (0.00%)  1/17 (5.88%) 
Pain  1  1/19 (5.26%)  0/17 (0.00%) 
Headache  1  5/19 (26.32%)  3/17 (17.65%) 
Infections and infestations     
Infection  1  1/19 (5.26%)  0/17 (0.00%) 
Injury, poisoning and procedural complications     
Accidental Injury  1  0/19 (0.00%)  1/17 (5.88%) 
Metabolism and nutrition disorders     
Dehydration  1  1/19 (5.26%)  0/17 (0.00%) 
Creatinine increased  1  2/19 (10.53%)  0/17 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/19 (5.26%)  0/17 (0.00%) 
Myalgia  1  1/19 (5.26%)  1/17 (5.88%) 
Nervous system disorders     
Dizziness  1  6/19 (31.58%)  5/17 (29.41%) 
Somnolence  1  0/19 (0.00%)  2/17 (11.76%) 
Renal and urinary disorders     
Urination impaired  1  1/19 (5.26%)  1/17 (5.88%) 
Leukorrhea  1  1/19 (5.26%)  0/17 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pharyngitis  1  1/19 (5.26%)  0/17 (0.00%) 
Rhinitis  1  1/19 (5.26%)  0/17 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne  1  1/19 (5.26%)  2/17 (11.76%) 
Erythema at site  1  13/19 (68.42%)  11/17 (64.71%) 
Pruritus  1  3/19 (15.79%)  1/17 (5.88%) 
Pruritus at site  1  7/19 (36.84%)  5/17 (29.41%) 
Rash  1  1/19 (5.26%)  0/17 (0.00%) 
Vascular disorders     
Vasodilatation  1  3/19 (15.79%)  2/17 (11.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Executive Medical Director, Clinical Pharmacology
Organization: Purdue Pharma L.P.
Phone: 800-733-1333
Layout table for additonal information
Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01259115     History of Changes
Other Study ID Numbers: BUP1009
First Submitted: December 10, 2010
First Posted: December 13, 2010
Results First Submitted: January 7, 2011
Results First Posted: January 26, 2011
Last Update Posted: May 19, 2014