Safety and Efficacy of Buprenorphine Transdermal System (... | NCT00313014

Label	Type	Description	Intervention Names
BTDS 5	Active Comparator	Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.	Drug: Buprenorphine
BTDS 20	Experimental	Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.	Drug: Buprenorphine
Oxycodone Immediate-Release	Experimental	Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).	Drug: Oxycodone Immediate-Release

Name	Type	Description	Arm Group Labels	Other Names
Buprenorphine	Drug	Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.	BTDS 5

Measure	Description	Time Frame
Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.	Subjects were evaluated during the double-blind phase for "average pain over the last 24 hours" prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)	Last 24 hours score at weeks 4, 8, 12 of the double-blind phase

Measure	Description	Time Frame
Mean Daily Number of Supplemental Analgesic Tablets	The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase	Double-blind phase (84 days)
Oswestry Disability Index (ODI) Score (V 2.0)

Name	Affiliation	Role
Martin Hale, MD	Gold Coast Research LLC, Weston, FL, USA	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Birmingham Pain Center		Birmingham	Alabama	35244	United States
Arthritis Clinical Intervention Program

PubMed Identifier	Type	Citation	Retractions
21807566	Result	Steiner D, Munera C, Hale M, Ripa S, Landau C. Efficacy and safety of buprenorphine transdermal system (BTDS) for chronic moderate to severe low back pain: a randomized, double-blind study. J Pain. 2011 Nov;12(11):1163-73. doi: 10.1016/j.jpain.2011.06.003. Epub 2011 Jul 31.

ID	Title	Description
FG000	Double-blind BTDS 5	Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
FG001	Double-blind BTDS 20	Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.

Subjects were evaluated during the double-blind phase for "average pain over the last 24 hours" prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)

Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.

Posted

Mean

Standard Error

units on a scale

Last 24 hours score at weeks 4, 8, 12 of the double-blind phase

ID	Title	Description
OG000	Double-blind BTDS 5	Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
OG001	Double-blind BTDS 20	Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
OG002	Double-blind Oxycodone Immediate-Release	Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).

Units	Counts
Participants	OG000221 OG001219 OG002220

Title

Denominators

Categories

Screening

Title	Measurements
	OG0006.36± 0.075 OG0016.46± 0.084 OG0026.46± 0.079

Prerandomization

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.	Mixed Models Analysis	Repeated measures mixed linear model with treatment, time, and time by treatment interaction as fixed effects.	<.001	P value was 2-sided and performed at the 5% error level.	Mean Difference (Final Values)	-0.67	Standard Error of the Mean	0.163	2-Sided	95	-0.99	-0.35				No

Secondary

Mean Daily Number of Supplemental Analgesic Tablets

The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase

Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.

Posted

Mean

Standard Error

tablets

Double-blind phase (84 days)

ID	Title	Description
OG000	Double-blind BTDS 5	Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
OG001	Double-blind BTDS 20	Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
OG002	Double-blind Oxycodone Immediate-Release	Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).

Units	Counts
Participants

Secondary

Oswestry Disability Index (ODI) Score (V 2.0)

The ODI (version 2) is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes.

The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0 = good to 5 = worse). (Note: A higher score represents greater disability.)

Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.

Posted

Mean

Standard Error

units on a scale

Weeks 4, 8, 12

ID	Title	Description
OG000	Double-blind BTDS 5	Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
OG001	Double-blind BTDS 20	Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
OG002	Double-blind Oxycodone Immediate-Release	Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).

Secondary

The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12.

The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity/ optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath).

Question 1 is scored on a scale of 1 to 5 and Questions 3 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.

Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.

Posted

Mean

Standard Error

units on a scale

Weeks 4, 8, 12 of the double-blind phase

ID	Title	Description
OG000	Double-blind BTDS 5	Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
OG001	Double-blind BTDS 20	Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
OG002	Double-blind Oxycodone Immediate-Release	Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Arrhythmia - DEATH	Cardiac disorders	MedDRA version 5.1	Systematic Assessment	Death Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG0031 events1 affected1,160 at risk
Brain arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0001 events1 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0001 events1 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Gastroenteritis	Gastrointestinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0001 events1 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Hematemesis	Gastrointestinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0011 events1 affected219 at risk EG0020 events0 affected220 at risk EG003
Intractable vomiting	Gastrointestinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0011 events1 affected219 at risk EG0020 events0 affected220 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0002 events2 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Chest pain	General disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Chest pressure	General disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0011 events1 affected219 at risk EG0020 events0 affected220 at risk EG003
Acute cholecystitis	Hepatobiliary disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0011 events1 affected219 at risk EG0020 events0 affected220 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0021 events1 affected220 at risk EG003
Worsening chronic cholecycstitis	Hepatobiliary disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0021 events1 affected220 at risk EG003
Left lower lobe pneumonia	Infections and infestations	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0001 events1 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Pneumonia	Infections and infestations	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0021 events1 affected220 at risk EG003
Right heel diabetic foot abscess	Infections and infestations	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Cocaine toxicity - DEATH	Injury, poisoning and procedural complications	MedDRA version 5.1	Systematic Assessment	Death Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Drowning - DEATH	Injury, poisoning and procedural complications	MedDRA version 5.1	Systematic Assessment	Death Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Shunt malfunction	Injury, poisoning and procedural complications	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Fracture distal right radius	Injury, poisoning and procedural complications	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Herniated disc	Musculoskeletal and connective tissue disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Clear cell carcinoma left ovary metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0021 events1 affected220 at risk EG003
Lower extremity lumbar radiculopathy	Nervous system disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0021 events1 affected220 at risk EG003
Lumbar spinal stenosis with diminution of L4-5	Nervous system disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0021 events1 affected220 at risk EG003
Nerve entrapment	Nervous system disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Depression worsening	Psychiatric disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0001 events1 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Kidney stones	Renal and urinary disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0021 events1 affected220 at risk EG003
Acute bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0021 events1 affected220 at risk EG003
Acute exacerbation of chronic obstructive pulmonary disease (COPD)	Respiratory, thoracic and mediastinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0021 events1 affected220 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Depressed respiration	Respiratory, thoracic and mediastinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0001 events1 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Exacerbation of COPD	Respiratory, thoracic and mediastinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0001 events1 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Left pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0001 events1 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0011 events1 affected219 at risk EG0020 events0 affected220 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Shortness of breath	Respiratory, thoracic and mediastinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Diaphoresis	Skin and subcutaneous tissue disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Abdominal aortic aneurysm	Vascular disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0011 events1 affected219 at risk EG0020 events0 affected220 at risk EG003
Hematoma, right thigh	Vascular disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0020 events0 affected220 at risk EG003
Acute axonal motor neuropathy	Nervous system disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0021 events1 affected220 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0021 events1 affected220 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0021 events1 affected220 at risk EG003
Guillain-Barre syndrome	Nervous system disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0010 events0 affected219 at risk EG0021 events1 affected220 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0011 events1 affected219 at risk EG0020 events0 affected220 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0011 events1 affected219 at risk EG0020 events0 affected220 at risk EG003
Increased total bilirubin	Investigations	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0011 events1 affected219 at risk EG0020 events0 affected220 at risk EG003
Right heel infection	Infections and infestations	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0000 events0 affected221 at risk EG0011 events1 affected219 at risk EG0020 events0 affected220 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG00018 affected221 at risk EG00127 affected219 at risk EG00218 affected220 at risk EG003174 affected1,160 at risk
Constipation	Gastrointestinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0007 affected221 at risk EG00114 affected219 at risk EG00214 affected220 at risk EG003
Vomiting NOS	Gastrointestinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0005 affected221 at risk EG00111 affected219 at risk EG0029 affected220 at risk EG003
Application site erythema	General disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG00010 affected221 at risk EG00122 affected219 at risk EG00219 affected220 at risk EG003
Application site pruritus	General disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG00012 affected221 at risk EG00129 affected219 at risk EG00220 affected220 at risk EG003
Application site rash	General disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG00017 affected221 at risk EG00120 affected219 at risk EG00213 affected220 at risk EG003
Upper respiratory tract infection NOS	Infections and infestations	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0003 affected221 at risk EG0014 affected219 at risk EG00210 affected220 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0005 affected221 at risk EG00110 affected219 at risk EG0024 affected220 at risk EG003
Headache	Nervous system disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG00012 affected221 at risk EG00125 affected219 at risk EG00221 affected220 at risk EG003
Somnolence	Nervous system disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0004 affected221 at risk EG00110 affected219 at risk EG00211 affected220 at risk EG003
Dizziness	Nervous system disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0005 affected221 at risk EG00110 affected219 at risk EG0028 affected220 at risk EG003
Nasopharyngitis	Respiratory, thoracic and mediastinal disorders	MedDRA version 5.1	Systematic Assessment	Systematic and nonsystematic assessments	EG0005 affected221 at risk EG00110 affected219 at risk EG0027 affected220 at risk EG003

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D006572	Heterocyclic Compounds, Bridged-Ring
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D010616	Phenanthrenes
D011084	Polycyclic Aromatic Hydrocarbons
D011083	Polycyclic Compounds

ID	Title	Description
BG000	Double-blind BTDS 5	Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
BG001	Double-blind BTDS 20	Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
BG002	Double-blind Oxycodone Immediate-Release	Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Double-blind BTDS 5	Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear	6	221	54	221
EG001	Double-blind BTDS 20	Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear	7	219	118	219
EG002	Double-blind Oxycodone Immediate-Release	Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).	9	220	93	220
EG003	Open-label Run-in Period, BTDS 10/20	Open-label BTDS 10 or 20 mcg/h applied for 7-day wear	10	1,160	389	1,160