An Efficacy and Safety Study of Fentanyl (JNS020QD) in Participants With Cancer Pain

• Sponsor: Janssen Pharmaceutical K.K. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00641667
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 13.2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants switched from morphine preparations, oral oxycodone preparations, fentanyl citrate injection or fentanyl patch for cancer pain.

Condition or Disease	Intervention/Treatment	Phase
Pain; Cancer	Drug: Fentanyl	Phase 3

Detailed Description

This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than one center) and non-comparative study of fentanyl one-day transdermal patch. The study consists of 3 periods: Pre-treatment observation period (4-7 days), Treatment period (10 days) and Follow-up period (2 days). Treatment will be initiated at 12.5 microgram per hour (mcg/hr) and the initial dose of fentanyl will be determined based on the daily dose of the opioid analgesic taken by the participant before entering the study and will be maintained for 2 days to ensure safety of participants. Dose escalation or reduction will be as per the Investigator's discretion from Day 3 to Day 7 and thereafter dose will be again maintained from Day 7 to Day 9, ranging from 12.5 mcg/hr-100 mcg/hr and the maximum application dose will be 300 mcg/hr. The patch will be applied on areas including the chest, abdomen, upper arm or thigh and will be replaced daily for 10 days (a total of 9 applications; including the day of final patch removal). Efficacy will primarily be evaluated by visual analog scale (VAS) score. Participants' safety will be monitored throughout the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III Study of JNS020QD in Cancer Pain Patients - Evaluation of the Efficacy and Safety of JNS020QD Switched From Opioid Analgesics
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Fentanyl

Drug: Fentanyl; Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is as per Investigator's discretion (maximum applied dose is 300 mcg/hr) up to Day 7 and then dose is fixed for next 3 days that is Day 10 (end of treatment period).; Other Names: JNS020QD

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving Pain Control [Day 10 or early discontinuation (ED)]

   Pain control was assessed based on change in Visual Analog Scale (VAS) and number of daily rescue doses during 3 days before completion of study drug from 3 days before start of study drug. For VAS score, a difference of less than or equal to +15 millimeter (mm) and for rescue doses, a difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS ranged from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting opioid analgesic (except fentanyl preparations) used for lack of analgesic effect.

Secondary Outcome Measures

1. Number of Participants With Response Based on Patient's Global Assessment Scale [Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED]

   Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug 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.

2. Pain Intensity Visual Analog Scale (VAS) Score [Day 1 (pre-application), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED]

   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".

3. Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain [Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED]

   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.

4. Number of Participants With Total Duration of Pain Per Day [Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED]

   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).

5. Mean Number of Rescue Doses [Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED]

   Rescue dose was defined as the dose of a fast-acting opioid analgesic (except fentanyl preparations) given in case of breakthrough pain or lack of analgesic effect.

6. Number of Participants With Response Based on Physician's Global Assessment Scale [Day 10 or ED]

   The treating physician assessed the therapeutic efficacy (effectiveness) of the study drug by 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants receiving any of the following drugs at a stable dose for at least 3 days (or 9 days in case of fentanyl patch) before the start of application of the study drug: Morphine preparations at less than or equal to 314 milligram per day (mg/day) as an oral morphine equivalent dose of less than or equal to 157 mg/day for suppository or less than or equal to 104 mg/day for injection, oral oxycodone preparations at less than or equal to 209 mg/day, fentanyl citrate injection at less than or equal to 2.0 mg/day, fentanyl patch less than or equal to 7.5 mg

• Participants assumed to use not more than 2 rescue doses (dose of a fast-acting opioid analgesic except fentanyl preparations used for lack of analgesic effect) daily for at least 3 days before the start of application of the study drug

• Participants showing a pain intensity of less than or equal to 34 millimeter (mm) on a 100-mm visual analog scale (VAS)

• Participants who have an established diagnosis of cancer and are notified of the disease

• Participants who can be hospitalized during the course of application of the study drug

Exclusion Criteria:

• Participants with impaired respiratory function due to chronic lung disease or others

• Participants with asthma (breathing disorder in which there is wheezing and difficulty in breathing or participants with bradyarrhythmia (slow, irregular heartbeats)

• Participants with following measurements indicative of hepatic or renal impairment during the pre-treatment observation period: Aspartate transaminase (AST) greater than 5 times the upper limit of reference range, Alanine transaminase (ALT) greater than 5 times the upper limit of reference range, serum creatinine greater than 3 times the upper limit of reference range

• Participants with any cerebral damage, such as brain tumor, accompanied by increased intracranial pressure, disturbance of consciousness, coma, or respiratory disturbance

• Participants with a history of hypersensitivity to fentanyl or other opioid analgesics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Kitakyushu		Japan

Sponsors and Collaborators

• Janssen Pharmaceutical K.K.

Investigators

• Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial, Janssen Pharmaceutical K.K.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen Pharmaceutical K.K.
• ClinicalTrials.gov Identifier: NCT00641667
• Other Study ID Numbers: CR014896; JNS020QD-JPN-C01
• First Posted: Mar 24, 2008
• Last Update Posted: Jun 7, 2013
• Last Verified: May 1, 2013

• Keywords provided by Janssen Pharmaceutical K.K.: Pain; Cancer; Fentanyl; JNS020QD
• Additional relevant MeSH terms: Cancer Pain; Fentanyl

Study Results

Participant Flow

Arm/Group Title	Fentanyl
Arm/Group Description	Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
Period Title: Overall Study
STARTED	66
COMPLETED	60
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Fentanyl
Arm/Group Description	Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
Overall Participants	66
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	63.80 (12.67)
Sex: Female, Male (Count of Participants)
Female	31 47%
Male	35 53%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving Pain Control
Description	Pain control was assessed based on change in Visual Analog Scale (VAS) and number of daily rescue doses during 3 days before completion of study drug from 3 days before start of study drug. For VAS score, a difference of less than or equal to +15 millimeter (mm) and for rescue doses, a difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS ranged from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting opioid analgesic (except fentanyl preparations) used for lack of analgesic effect.
Time Frame	Day 10 or early discontinuation (ED)

Outcome Measure Data

Analysis Population Description

Full Analysis Set (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 Title	Fentanyl
Arm/Group Description	Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
Measure Participants	66
Number (95% Confidence Interval) [Percentage of Participants]	81.8 123.9%

2. Secondary Outcome

Title	Number of Participants With Response Based on Patient's Global Assessment Scale
Description	Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug 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.
Time Frame	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Fentanyl
Arm/Group Description	Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
Measure Participants	66
Day 1; Extremely satisfied (n=66)	8 12.1%
Day 1; Satisfied (n=66)	35 53%
Day 1; Neither satisfied nor dissatisfied (n=66)	19 28.8%
Day 1; Dissatisfied (n=66)	4 6.1%
Day 1; Extremely dissatisfied (n=66)	0 0%
Day 2; Extremely satisfied (n=65)	8 12.1%
Day 2; Satisfied (n=65)	31 47%
Day 2; Neither satisfied nor dissatisfied (n=65)	24 36.4%
Day 2; Dissatisfied (n=65)	2 3%
Day 2; Extremely dissatisfied (n=65)	0 0%
Day 3; Extremely satisfied (n=65)	8 12.1%
Day 3; Satisfied (n=65)	25 37.9%
Day 3; Neither satisfied nor dissatisfied (n=65)	25 37.9%
Day 3; Dissatisfied (n=65)	7 10.6%
Day 3; Extremely dissatisfied (n=65)	0 0%
Day 4; Extremely satisfied (n=64)	9 13.6%
Day 4; Satisfied (n=64)	28 42.4%
Day 4; Neither satisfied nor dissatisfied (n=64)	24 36.4%
Day 4; Dissatisfied (n=64)	3 4.5%
Day 4; Extremely dissatisfied (n=64)	0 0%
Day 5; Extremely satisfied (n=63)	10 15.2%
Day 5; Satisfied (n=63)	30 45.5%
Day 5; Neither satisfied nor dissatisfied (n=63)	19 28.8%
Day 5; Dissatisfied (n=63)	3 4.5%
Day 5; Extremely dissatisfied (n=63)	1 1.5%
Day 6; Extremely satisfied (n=63)	9 13.6%
Day 6; Satisfied (n=63)	31 47%
Day 6; Neither satisfied nor dissatisfied (n=63)	20 30.3%
Day 6; Dissatisfied (n=63)	3 4.5%
Day 6; Extremely dissatisfied (n=63)	0 0%
Day 7; Extremely satisfied (n=63)	10 15.2%
Day 7; Satisfied (n=63)	31 47%
Day 7; Neither satisfied nor dissatisfied (n=63)	18 27.3%
Day 7; Dissatisfied (n=63)	4 6.1%
Day 7; Extremely dissatisfied (n=63)	0 0%
Day 8; Extremely satisfied (n=62)	10 15.2%
Day 8; Satisfied (n=62)	30 45.5%
Day 8; Neither satisfied nor dissatisfied (n=62)	19 28.8%
Day 8; Dissatisfied (n=62)	3 4.5%
Day 8; Extremely dissatisfied (n=62)	0 0%
Day 9; Extremely satisfied (n=62)	11 16.7%
Day 9; Satisfied (n=62)	32 48.5%
Day 9; Neither satisfied nor dissatisfied (n=62)	17 25.8%
Day 9; Dissatisfied (n=62)	2 3%
Day 9; Extremely dissatisfied (n=62)	0 0%
Day 10/ED; Extremely satisfied (n=66)	10 15.2%
Day 10/ED; Satisfied (n=66)	30 45.5%
Day 10/ED;Neither satisfied nor dissatisfied(n=66)	20 30.3%
Day 10/ED; Dissatisfied (n=66)	6 9.1%
Day 10/ED; Extremely dissatisfied (n=66)	0 0%

3. Secondary Outcome

Title	Pain Intensity Visual Analog Scale (VAS) Score
Description	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".
Time Frame	Day 1 (pre-application), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Fentanyl
Arm/Group Description	Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
Measure Participants	66
Day 1 pre-application; (n=66)	15.6 (11.77)
Day 2; (n=65)	16.1 (11.95)
Day 3; (n=65)	18.6 (15.84)
Day 4; (n=64)	15.1 (13.09)
Day 5; (n=63)	15.2 (14.31)
Day 6; (n=63)	15.3 (12.68)
Day 7; (n=63)	14.7 (13.47)
Day 8; (n=62)	14.9 (14.34)
Day 9; (n=62)	15.1 (13.38)
Day 10 or ED; (n=66)	15.5 (13.34)

4. Secondary Outcome

Title	Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Description	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.
Time Frame	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Fentanyl
Arm/Group Description	Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
Measure Participants	66
Day 1; No pain (n=66)	12 18.2%
Day 1; Mild pain (n=66)	37 56.1%
Day 1; Moderate pain (n=66)	17 25.8%
Day 1; Severe pain (n=66)	0 0%
Day 2; No pain (n=65)	10 15.2%
Day 2; Mild pain (n=65)	34 51.5%
Day 2; Moderate pain (n=65)	21 31.8%
Day 2; Severe pain (n=65)	0 0%
Day 3; No pain (n=65)	14 21.2%
Day 3; Mild pain (n=65)	33 50%
Day 3; Moderate pain (n=65)	15 22.7%
Day 3; Severe pain (n=65)	3 4.5%
Day 4; No pain (n=64)	16 24.2%
Day 4; Mild pain (n=64)	34 51.5%
Day 4; Moderate pain (n=64)	13 19.7%
Day 4; Severe pain (n=64)	1 1.5%
Day 5; No pain (n=63)	15 22.7%
Day 5; Mild pain (n=63)	36 54.5%
Day 5; Moderate pain (n=63)	12 18.2%
Day 5; Severe pain (n=63)	0 0%
Day 6; No pain (n=63)	16 24.2%
Day 6; Mild pain (n=63)	38 57.6%
Day 6; Moderate pain (n=63)	8 12.1%
Day 6; Severe pain (n=63)	1 1.5%
Day 7; No pain (n=63)	14 21.2%
Day 7; Mild pain (n=63)	38 57.6%
Day 7; Moderate pain (n=63)	11 16.7%
Day 7; Severe pain (n=63)	0 0%
Day 8; No pain (n=62)	13 19.7%
Day 8; Mild pain (n=62)	38 57.6%
Day 8; Moderate pain (n=62)	11 16.7%
Day 8; Severe pain (n=62)	0 0%
Day 9; No pain (n=62)	14 21.2%
Day 9; Mild pain (n=62)	40 60.6%
Day 9; Moderate pain (n=62)	7 10.6%
Day 9; Severe pain (n=62)	1 1.5%
Day 10 or ED; No pain (n=66)	15 22.7%
Day 10 or ED; Mild pain (n=66)	40 60.6%
Day 10 or ED; Moderate pain(n=66)	8 12.1%
Day 10 or ED; Severe pain(n=66)	3 4.5%

5. Secondary Outcome

Title	Number of Participants With Total Duration of Pain Per Day
Description	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).
Time Frame	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Fentanyl
Arm/Group Description	Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
Measure Participants	66
Day 1; < 4 hours (n=66)	44 66.7%
Day 1; >= 4 to < 8 hours (n=66)	9 13.6%
Day 1; >= 8 to < 12 hours (n=66)	6 9.1%
Day 1; >= 12 hours (n=66)	0 0%
Day 1; 24 hours (n=66)	7 10.6%
Day 2; < 4 hours (n=65)	44 66.7%
Day 2; >= 4 to < 8 hours (n=65)	9 13.6%
Day 2; >= 8 to < 12 hours (n=65)	6 9.1%
Day 2; >= 12 hours (n=65)	1 1.5%
Day 2; 24 hours (n=65)	5 7.6%
Day 3; < 4 hours (n=65)	41 62.1%
Day 3; >= 4 to < 8 hours (n=65)	6 9.1%
Day 3; >= 8 to < 12 hours (n=65)	9 13.6%
Day 3; >= 12 hours (n=65)	3 4.5%
Day 3; 24 hours (n=65)	6 9.1%
Day 4; < 4 hours (n=64)	47 71.2%
Day 4; >= 4 to < 8 hours (n=64)	8 12.1%
Day 4; >= 8 to < 12 hours (n=64)	2 3%
Day 4; >= 12 hours (n=64)	2 3%
Day 4; 24 hours (n=64)	5 7.6%
Day 5; < 4 hours (n=63)	45 68.2%
Day 5; >= 4 to < 8 hours (n=63)	10 15.2%
Day 5; >= 8 to < 12 hours (n=63)	2 3%
Day 5; >= 12 hours (n=63)	1 1.5%
Day 5; 24 hours (n=63)	5 7.6%
Day 6; < 4 hours (n=63)	46 69.7%
Day 6; >= 4 to < 8 hours (n=63)	6 9.1%
Day 6; >= 8 to < 12 hours (n=63)	3 4.5%
Day 6; >= 12 hours (n=63)	1 1.5%
Day 6; 24 hours (n=63)	7 10.6%
Day 7; < 4 hours (n=63)	44 66.7%
Day 7; >= 4 to < 8 hours (n=63)	7 10.6%
Day 7; >= 8 to < 12 hours (n=63)	4 6.1%
Day 7; >= 12 hours (n=63)	1 1.5%
Day 7; 24 hours (n=63)	7 10.6%
Day 8; < 4 hours (n=62)	44 66.7%
Day 8; >= 4 to < 8 hours (n=62)	6 9.1%
Day 8; >= 8 to < 12 hours (n=62)	4 6.1%
Day 8; >= 12 hours (n=62)	1 1.5%
Day 8; 24 hours (n=62)	7 10.6%
Day 9; < 4 hours (n=62)	47 71.2%
Day 9; >= 4 to < 8 hours (n=62)	6 9.1%
Day 9; >= 8 to < 12 hours (n=62)	3 4.5%
Day 9; >= 12 hours (n=62)	1 1.5%
Day 9; 24 hours (n=62)	5 7.6%
Day 10 or ED; < 4 hours (n=66)	50 75.8%
Day 10 or ED; >=4 to < 8 hours (n=66)	6 9.1%
Day 10 or ED; >=8 to <12 hours (n=66)	3 4.5%
Day 10 or ED; >= 12 hours (n=66)	2 3%
Day 10 or ED; 24 hours (n=66)	5 7.6%

6. Secondary Outcome

Title	Mean Number of Rescue Doses
Description	Rescue dose was defined as the dose of a fast-acting opioid analgesic (except fentanyl preparations) given in case of breakthrough pain or lack of analgesic effect.
Time Frame	Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Fentanyl
Arm/Group Description	Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
Measure Participants	66
Day 1; (n=66)	0.2 (0.47)
Day 2; (n=65)	0.8 (1.06)
Day 3; (n=65)	0.7 (1.14)
Day 4; (n=64)	0.7 (1.04)
Day 5; (n=63)	0.7 (1.05)
Day 6; (n=63)	0.7 (1.10)
Day 7; (n=63)	0.8 (1.42)
Day 8; (n=62)	0.7 (1.14)
Day 9; (n=62)	0.8 (1.33)
Day 10 or ED; (n=66)	0.5 (0.83)

7. Secondary Outcome

Title	Number of Participants With Response Based on Physician's Global Assessment Scale
Description	The treating physician assessed the therapeutic efficacy (effectiveness) of the study drug by 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.
Time Frame	Day 10 or ED

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Fentanyl
Arm/Group Description	Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
Measure Participants	66
Effective	63 95.5%
Ineffective	3 4.5%

Adverse Events

Time Frame	From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
Arm/Group Title	Fentanyl
Arm/Group Description	Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
All Cause Mortality
	Fentanyl
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Fentanyl
	Affected / at Risk (%)	# Events
Total	6/66 (9.1%)
Blood and lymphatic system disorders
Thrombocytopenia	1/66 (1.5%)
Gastrointestinal disorders
Ileus	1/66 (1.5%)
Intestinal obstruction	1/66 (1.5%)
Infections and infestations
Pneumonia	1/66 (1.5%)
Staphylococcal sepsis	1/66 (1.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes	1/66 (1.5%)
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration	1/66 (1.5%)
Other (Not Including Serious) Adverse Events
	Fentanyl
	Affected / at Risk (%)	# Events
Total	56/66 (84.8%)
Gastrointestinal disorders
Constipation	34/66 (51.5%)
Diarrhoea	16/66 (24.2%)
Nausea	25/66 (37.9%)
Vomiting	23/66 (34.8%)
General disorders
Application site erythema	4/66 (6.1%)
Application site pruritus	7/66 (10.6%)
Pyrexia	4/66 (6.1%)
Infections and infestations
Nasopharyngitis	4/66 (6.1%)
Nervous system disorders
Dizziness	4/66 (6.1%)
Somnolence	36/66 (54.5%)
Psychiatric disorders
Insomnia	5/66 (7.6%)
Skin and subcutaneous tissue disorders
Erythema	4/66 (6.1%)
Pruritus	6/66 (9.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The disclosure restriction on PI is that the Sponsor can review results communications prior to public release and can embargo communications regarding results for a period as the Sponsor requires.