Trial Outcomes & Findings for An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Cancer Participants With Inadequately Controlled Pain by Non-Narcotic Analgesics (NCT NCT01060124)

NCT ID: NCT01060124

Last Updated: 2014-04-29

Results Overview

Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 103 participants
• Primary outcome timeframe: Day 29
• Results posted on: 2014-04-29

Participant Flow

Participant milestones

Measure	Transdermal Therapeutic System (TTS)-Fentanyl D-trans Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
Overall Study STARTED	103
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	37

Reasons for withdrawal

Measure	Transdermal Therapeutic System (TTS)-Fentanyl D-trans Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
Overall Study Other	16
Overall Study Adverse Event	14
Overall Study Withdrawal by Subject	7

Baseline Characteristics

An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Cancer Participants With Inadequately Controlled Pain by Non-Narcotic Analgesics

Baseline characteristics by cohort

Measure	Transdermal Therapeutic System (TTS)-Fentanyl D-trans n=98 Participants Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
Age, Continuous	60.81 years STANDARD_DEVIATION 12.93 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 29

Population: Per-Protocol (PP) analysis population included all participants who completed the clinical trial without violating the protocol among the participant who participated in the clinical trial.

Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans.

Outcome measures

Measure	Transdermal Therapeutic System (TTS)-Fentanyl D-trans n=64 Participants Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
Percentage of Participants Satisfied With Pain Treatment	82.81 percentage of participants Interval 73.57 to 92.06

SECONDARY outcome

Timeframe: Day 1 and Day 29

Population: Full Analysis (FAS) population included all participants who meet the inclusion and exclusion criteria.

Pain intensity difference was measured by Visual Analog Scale (VAS) score, which ranges from 0 to 10 centimeter (cm) where 0 cm=no pain and 10 cm= unimaginably severe pain.

Outcome measures

Measure	Transdermal Therapeutic System (TTS)-Fentanyl D-trans n=98 Participants Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans Day 1	6.61 units on a scale Standard Deviation 1.62
Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans Day 29	3.66 units on a scale Standard Deviation 2.42

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 29

Population: Full Analysis (FAS) population included all participants who meet the inclusion and exclusion criteria. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.

Participants were assessed for satisfaction for pain treatment after the administration of the TTS-fentanyl D-trans in detail with satisfied reasons, which are excellent pain relieving effect, convenient administration, minor adverse event, generally satisfied and other.

Outcome measures

Measure	Transdermal Therapeutic System (TTS)-Fentanyl D-trans n=75 Participants Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment Excellent pain relieving effect	32 participants
Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment Convenient administration	24 participants
Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment Minor adverse event	4 participants
Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment Generally Satisfied	15 participants
Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment Other	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 and Day 29

Population: Safety population included all participants who were administered the TTS-fentanyl D-trans at least once.

Dose of TTS-fentanyl D-trans were monitored at start and end of the trial.

Outcome measures

Measure	Transdermal Therapeutic System (TTS)-Fentanyl D-trans n=103 Participants Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
Initial and End Point Dose of TTS-Fentanyl D-trans Initial dose	12.00 microgram per hour (mcg/hr) Standard Deviation 0.00
Initial and End Point Dose of TTS-Fentanyl D-trans End-point dose	26.47 microgram per hour (mcg/hr) Standard Deviation 19.05

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 29

Population: Full Analysis (FAS) population included all those participants who meet the inclusion and exclusion criteria. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.

Investigator assessed the participants for satisfaction on pain treatment after the administration of the TTS-fentanyl D-trans as very satisfied, satisfied, average, dissatisfied or very dissatisfied.

Outcome measures

Measure	Transdermal Therapeutic System (TTS)-Fentanyl D-trans n=69 Participants Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
Number of Participants With Investigator's Overall Evaluation on the Pain Treatment Very Satisfied	16 participants
Number of Participants With Investigator's Overall Evaluation on the Pain Treatment Satisfied	43 participants
Number of Participants With Investigator's Overall Evaluation on the Pain Treatment Average	9 participants
Number of Participants With Investigator's Overall Evaluation on the Pain Treatment Dissatisfied	0 participants
Number of Participants With Investigator's Overall Evaluation on the Pain Treatment Very Dissatisfied	1 participants

Adverse Events

Transdermal Therapeutic System (TTS)-Fentanyl D-trans

Serious events: 18 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	Transdermal Therapeutic System (TTS)-Fentanyl D-trans n=103 participants at risk Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
General disorders Death	1.9% 2/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
General disorders Pyrexia	1.9% 2/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
General disorders Disease Progression	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Gastrointestinal disorders Abdominal distention	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Gastrointestinal disorders Abdominal Pain	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Gastrointestinal disorders Diarrhoea	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Gastrointestinal disorders Nausea	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Gastrointestinal disorders Vomiting	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Infections and infestations Liver abscess	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Infections and infestations Pneumonia	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Infections and infestations Septic shock	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Infections and infestations Urinary tract infection	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder Cancer	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Haemorrhage	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Musculoskeletal and connective tissue disorders Camptocormia	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Blood and lymphatic system disorders Neutropenia	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Cardiac disorders Cerebral infraction	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Investigations Haemoglobin decreased	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Metabolism and nutrition disorders Decreased appetite	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Nervous system disorders Cervical cord compression	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Renal and urinary disorders Renal failure acute	0.97% 1/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.

Other adverse events

Measure	Transdermal Therapeutic System (TTS)-Fentanyl D-trans n=103 participants at risk Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
Gastrointestinal disorders Nausea	19.4% 20/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Gastrointestinal disorders Vomiting	10.7% 11/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
Nervous system disorders Dizziness	11.7% 12/103 • Day 1 to Day 29 An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.

Additional Information

CRA

Medical affairs, Janssen Korea, Ltd.

Phone: 82220944835

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place