A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transd... | NCT00644787

NCT00644787

ID	Type	Description	Link
JNS020QD-JPN-C02

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fentanyl 1-day transdermal patch (Titration Phase)	Experimental	Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase enter the Double Blind Phase.	Drug: Fentanyl 1-day transdermal patch (Titration Phase)
Fentanyl 1-day transdermal patch (Double Blind Phase)	Experimental	Participants who meet the predefined criteria at the end of Titration Phase and enter the Double Blind Phase receive fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.	Drug: Fentanyl 1-day transdermal patch (Double Blind Phase) Drug: Placebo
Fentanyl 3-day transdermal patch (Double Blind Phase)	Active Comparator	Participants who meet the predefined criteria at the end of Titration Phase and enter the Double Blind Phase receive fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.	Drug: Fentanyl 3-day transdermal patch (Double Blind Phase) Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fentanyl 1-day transdermal patch (Titration Phase)	Drug	Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment period, that is Day 14.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving Dose Titration Success	Participants achieving dose titration success included all participants who had a mean Visual Analog Scale (VAS) score of less than or equal to 34 millimeter (mm) and received not more than 2 rescue doses during the last 3 days before the completion or discontinuation of dose titration phase. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain.	Day 14 or early discontinuation (ED)
Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase	The mean VAS score for the last 3 days before the completion or discontinuation of Double Blind Phase was compared with that for the last 3 days before the completion or discontinuation of Dose Titration Phase and the change from Dose Titration Phase in the mean VAS Score at Double Blind Phase was reported. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable).	Dose Titration Phase (Day 12 to Day 14) and Double Blind Phase (Day 8 to Day 10)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase	Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug to control pain on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Janssen Pharmaceutical K.K., Japan Clinical Trial	Janssen Pharmaceutical K.K.	Study Director

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Fentanyl 1-day Transdermal Patch (Titration Phase)	Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator's discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG000156 subjects
FG0010 subjects
FG0020 subjects

Out of a total of 156 participants, Baseline characteristics were available for only 155 participants who were included in Full Analysis Set (FAS) population. FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug.

Arm/Group Information

ID	Title	Description
BG000	Fentanyl 1-day Transdermal Patch (Titration Phase)	Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator's discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG00080.60(73.50 to 86.50)

Primary

Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase

The mean VAS score for the last 3 days before the completion or discontinuation of Double Blind Phase was compared with that for the last 3 days before the completion or discontinuation of Dose Titration Phase and the change from Dose Titration Phase in the mean VAS Score at Double Blind Phase was reported. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable).

Per Protocol Set (PPS) population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations.

Posted

Mean

Standard Deviation

Dose Titration Phase (Day 12 to Day 14) and Double Blind Phase (Day 8 to Day 10)

ID	Title	Description
OG000	Fentanyl 1-day Transdermal Patch (Double Blind Phase)	Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
OG001	Fentanyl 3-day Transdermal Patch (Double Blind Phase)	Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

Secondary

Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase

Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug to control pain on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.

The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.

Posted

Number

Participants

Day 1 pre-application (PA), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED

ID	Title	Description
OG000	Fentanyl 1-day Transdermal Patch (Titration Phase)	Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator's discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.

Secondary

Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase

Participants were asked to assess their satisfaction with respect to the therapeutic efficacy of the study drug to control pain on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.

The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.

Posted

Number

Participants

Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED

ID	Title	Description
OG000	Fentanyl 1-day Transdermal Patch (Double Blind Phase)	Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
OG001	Fentanyl 3-day Transdermal Patch (Double Blind Phase)	Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

Secondary

Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase

Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as "no pain" and the right edge (100 mm) defined as "severest pain conceivable".

Posted

Mean

Standard Deviation

Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED

ID	Title	Description
OG000	Fentanyl 1-day Transdermal Patch (Titration Phase)	Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator's discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.

Units	Counts
Participants

Secondary

Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase

Posted

Mean

Standard Deviation

Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED

ID	Title	Description
OG000	Fentanyl 1-day Transdermal Patch (Double Blind Phase)	Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
OG001	Fentanyl 3-day Transdermal Patch (Double Blind Phase)	Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

Secondary

Percentage of Participants Achieving Pain Control in Double Blind Phase

Pain control was assessed based on change in VAS and number of daily rescue doses during 3 days before completion of Double Blind Phase from 3 days before start of Double Blind Phase. For VAS score, difference of less than or equal to +15 mm and for rescue doses, difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS measured pain severity on a scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting oral morphine formulation used in case of breakthrough pain.

Posted

Number

95% Confidence Interval

Percentage of participants

Day 10 or ED

ID	Title	Description
OG000	Fentanyl 1-day Transdermal Patch (Double Blind Phase)	Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
OG001	Fentanyl 3-day Transdermal Patch (Double Blind Phase)

Secondary

Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase

Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain.

Posted

Number

Participants

Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED

ID	Title	Description
OG000	Fentanyl 1-day Transdermal Patch (Titration Phase)	Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator's discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.

Units	Counts
Participants

Secondary

Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase

Posted

Number

Participants

Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED

ID	Title	Description
OG000	Fentanyl 1-day Transdermal Patch (Double Blind Phase)	Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
OG001	Fentanyl 3-day Transdermal Patch (Double Blind Phase)	Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

Secondary

Number of Participants With Total Duration of Pain Per Day in Titration Phase

The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (<) 4 hours, 1 = greater than or equal to (>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day).

Posted

Number

Participants

Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED

ID	Title	Description
OG000	Fentanyl 1-day Transdermal Patch (Titration Phase)	Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator's discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.

Units	Counts

Secondary

Number of Participants With Total Duration of Pain Per Day in Double Blind Phase

Posted

Number

Participants

Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED

ID	Title	Description
OG000	Fentanyl 1-day Transdermal Patch (Double Blind Phase)	Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
OG001	Fentanyl 3-day Transdermal Patch (Double Blind Phase)	Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

Secondary

Mean Number of Rescue Doses in Titration Phase

Rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain or lack of analgesic effect.

Posted

Mean

Standard Deviation

Rescue doses

Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED

ID	Title	Description
OG000	Fentanyl 1-day Transdermal Patch (Titration Phase)	Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator's discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.

Units	Counts
Participants

Secondary

Mean Number of Rescue Doses in Double Blind Phase

Rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain or lack of analgesic effect.

Posted

Mean

Standard Deviation

Rescue doses

Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED

ID	Title	Description
OG000	Fentanyl 1-day Transdermal Patch (Double Blind Phase)	Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
OG001	Fentanyl 3-day Transdermal Patch (Double Blind Phase)	Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

Secondary

Number of Participants With Response Based on Physician's Global Assessment Scale in Titration Phase

The treating physician assessed the therapeutic efficacy of the study drug to control pain on a 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.

The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Posted

Number

Participants

Day 14

ID	Title	Description
OG000	Fentanyl 1-day Transdermal Patch (Titration Phase)	Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator's discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.

Units	Counts
Participants

Secondary

Number of Participants With Response Based on Physician's Global Assessment Scale in Double Blind Phase

Posted

Number

Percentage of participants

Day 10

ID	Title	Description
OG000	Fentanyl 1-day Transdermal Patch (Double Blind Phase)	Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
OG001	Fentanyl 3-day Transdermal Patch (Double Blind Phase)	Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Fentanyl 1-day Transdermal Patch (Titration Phase)	Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction was done as per Investigator's discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase.	14	155	128	155
EG001	Fentanyl 1-day Transdermal Patch (Double Blind Phase)	Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.	9	57	47	57
EG002	Fentanyl 3-day Transdermal Patch (Double Blind Phase)	Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.	11	62	48	62

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Sepsis	Infections and infestations	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected155 at risk EG0010 affected57 at risk EG0020 affected62 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 11.0	Non-systematic Assessment	EG0002 affected155 at risk EG0011 affected57 at risk EG0020 affected62 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected155 at risk EG0010 affected57 at risk EG0021 affected62 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 11.0	Non-systematic Assessment	EG0002 affected155 at risk EG0011 affected57 at risk EG0021 affected62 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected155 at risk EG0010 affected57 at risk EG0020 affected62 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected155 at risk EG0010 affected57 at risk EG0020 affected62 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 11.0	Non-systematic Assessment	EG0002 affected155 at risk EG0010 affected57 at risk EG0020 affected62 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected155 at risk EG0011 affected57 at risk EG0020 affected62 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0002 affected155 at risk EG0010 affected57 at risk EG0020 affected62 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected155 at risk EG0010 affected57 at risk EG0020 affected62 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected155 at risk EG0010 affected57 at risk EG0020 affected62 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0003 affected155 at risk EG0011 affected57 at risk EG0020 affected62 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0001 affected155 at risk EG0010 affected57 at risk EG0021 affected62 at risk
Pneumonia	Infections and infestations	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0010 affected57 at risk EG0021 affected62 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0010 affected57 at risk EG0022 affected62 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0010 affected57 at risk EG0021 affected62 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0010 affected57 at risk EG0021 affected62 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0010 affected57 at risk EG0021 affected62 at risk
Oral intake reduced	Metabolism and nutrition disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0010 affected57 at risk EG0021 affected62 at risk
Anxiety	Psychiatric disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0011 affected57 at risk EG0020 affected62 at risk
Cerebral infarction	Nervous system disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0011 affected57 at risk EG0020 affected62 at risk
Haemorrhage	Vascular disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0010 affected57 at risk EG0021 affected62 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0011 affected57 at risk EG0020 affected62 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0011 affected57 at risk EG0020 affected62 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0010 affected57 at risk EG0021 affected62 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0011 affected57 at risk EG0022 affected62 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0011 affected57 at risk EG0020 affected62 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Somnolence	Nervous system disorders	MedDRA Version 11.0	Non-systematic Assessment	EG00093 affected155 at risk EG00134 affected57 at risk EG00236 affected62 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG00078 affected155 at risk EG00131 affected57 at risk EG00236 affected62 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG00011 affected155 at risk EG0018 affected57 at risk EG00213 affected62 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG00074 affected155 at risk EG00132 affected57 at risk EG00234 affected62 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 11.0	Non-systematic Assessment	EG00045 affected155 at risk EG00117 affected57 at risk EG00223 affected62 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA Version 11.0	Non-systematic Assessment	EG00011 affected155 at risk EG0014 affected57 at risk EG0025 affected62 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 11.0	Non-systematic Assessment	EG00011 affected155 at risk EG0016 affected57 at risk EG0025 affected62 at risk
Application site erythema	General disorders	MedDRA Version 11.0	Non-systematic Assessment	EG00012 affected155 at risk EG0017 affected57 at risk EG0027 affected62 at risk
Application site pruritus	General disorders	MedDRA Version 11.0	Non-systematic Assessment	EG00010 affected155 at risk EG0014 affected57 at risk EG0022 affected62 at risk
Pyrexia	General disorders	MedDRA Version 11.0	Non-systematic Assessment	EG00012 affected155 at risk EG0016 affected57 at risk EG0025 affected62 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0011 affected57 at risk EG0024 affected62 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0013 affected57 at risk EG0021 affected62 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0013 affected57 at risk EG0020 affected62 at risk
Delirium	Psychiatric disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0015 affected57 at risk EG0024 affected62 at risk
Insomnia	Psychiatric disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0015 affected57 at risk EG0023 affected62 at risk
Restlessness	Psychiatric disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0014 affected57 at risk EG0020 affected62 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0013 affected57 at risk EG0022 affected62 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0014 affected57 at risk EG0026 affected62 at risk
Malaise	General disorders	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0013 affected57 at risk EG0022 affected62 at risk
Blood urea increased	Investigations	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0013 affected57 at risk EG0021 affected62 at risk
Platelet count decreased	Investigations	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0013 affected57 at risk EG0021 affected62 at risk
White blood cell count decreased	Investigations	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0013 affected57 at risk EG0024 affected62 at risk
White blood cell count increased	Investigations	MedDRA Version 11.0	Non-systematic Assessment	EG0000 affected155 at risk EG0016 affected57 at risk EG0020 affected62 at risk

ID	Term
D010146	Pain
D009369	Neoplasms

ID	Term
D005283	Fentanyl
D057968	Transdermal Patch

Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.

Facility	Status	City	State	ZIP	Country	Contacts
		Asahi			Japan

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D004864	Equipment and Supplies