Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN) (NCT NCT01675531)

Last Updated: 2016-12-16

Results Overview

Change of pain intensity score via NRS after vist 4 weeks treatment from baseline (week 0). NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week4/ET minus mean score at Baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

73 participants

Primary outcome timeframe

4 weeks

Results posted on

2016-12-16

Participant Flow

Safety set: 72 subjects ITT set: 66 subjects PP set: 41 subjects.

73 Patients was enrolled. However, 1 patient was not administered investigational drug. So the patient excluded from safety set.

Participant milestones

Participant milestones
Measure	Oxycontin/Naloxone Targin(Oxycontin/Naloxone) Targin: Single arm for Targin
Overall Study STARTED	66
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Oxycontin/Naloxone Targin(Oxycontin/Naloxone) Targin: Single arm for Targin
Overall Study Adverse Event	9
Overall Study Withdrawal by Subject	7
Overall Study Lack of Efficacy	1
Overall Study Protocol Violation	8

Baseline Characteristics

A Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxycodone/Naloxone n=72 Participants Targin Targin: Single arm for Targin
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants
Age, Categorical >=65 years	36 Participants n=5 Participants
Age, Continuous	62.97 years STANDARD_DEVIATION 8.99 • n=5 Participants
Age, Customized 18~29	0 participants n=5 Participants
Age, Customized 30~39	1 participants n=5 Participants
Age, Customized 40~49	4 participants n=5 Participants
Age, Customized 50~59	20 participants n=5 Participants
Age, Customized 60~69	34 participants n=5 Participants
Age, Customized >70	13 participants n=5 Participants
Gender Female	21 Participants n=5 Participants
Gender Male	51 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Analysis of ITT population set. Missing data was handled as LOCF(Last Observation Carried Forward Method).

Outcome measures

Outcome measures
Measure	Oxycodone/Naloxone n=66 Participants Targin Targin: Single arm for Targin
NRS (Numeric Rating Scale)	-1.29 units on a scale Standard Deviation 1.84

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis of ITT population set.

Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FAICT-GOG/NTX). The mean changes in FACT/GOG-NTX total score and each FACT/GOG-NTX subscale score from Visit 1 (Week 0) to Visit 4 (Week 4 post-treatment) were analyzed. Missing data was handled as LOCF(Last Observation Carried Forward Method). FACT/GOG-NTX total score range was from 0 to 152. The average change score from baseline to visit 4 indicates thay a lower score on the FACT/GOG-NTX means lower quality of life and a greater impact of neurotoxic symptom on the patient's life.

Outcome measures

Outcome measures
Measure	Oxycodone/Naloxone n=66 Participants Targin Targin: Single arm for Targin
Mean Change in FACT-GOG/NTX From Visit1(Week 0) to Visit 4(Week 4 Post-treatment).	-2.78 units on a scale Standard Deviation 17.66

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis of ITT population set.

Physician's overall satisfaction was scored 7 scales from Very much worse to Very much improved. (Very much worse, much worse, minimally worse, No change, Minimally improved, much improved, very much improved).

Outcome measures

Outcome measures
Measure	Oxycodone/Naloxone n=66 Participants Targin Targin: Single arm for Targin
Physician's Overall Satisfaction Very much worse	0 participants
Physician's Overall Satisfaction much worse	3 participants
Physician's Overall Satisfaction minimally worse	2 participants
Physician's Overall Satisfaction No change	25 participants
Physician's Overall Satisfaction Minimally improved	19 participants
Physician's Overall Satisfaction Much improved	16 participants
Physician's Overall Satisfaction Very much improved	1 participants

SECONDARY outcome

Timeframe: 4weeks

Population: Analysis of ITT population set.

Patient's overall satisfaction was assessed 7 scales from very much worse to very much improved. (Very much worse, much worse, minimally worse, no change, minimally improved, much improved, very much improved)

Outcome measures

Outcome measures
Measure	Oxycodone/Naloxone n=66 Participants Targin Targin: Single arm for Targin
Patient's Overall Satisfaction Very much worse	0 participants
Patient's Overall Satisfaction Much worse	3 participants
Patient's Overall Satisfaction Minimally worse	2 participants
Patient's Overall Satisfaction No change	26 participants
Patient's Overall Satisfaction Minimally improved	15 participants
Patient's Overall Satisfaction Much improved	18 participants
Patient's Overall Satisfaction Very much improved	2 participants

Adverse Events

Oxycodone/Naloxone

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oxycodone/Naloxone n=72 participants at risk Targin(Oxycodone/Naloxone) Targin: Single arm for Targin
Investigations Neutrophil count decreased	1.4% 1/72 • Number of events 1 • 4weeks
Nervous system disorders Mental inpairment	1.4% 1/72 • Number of events 1 • 4weeks

Other adverse events

Other adverse events
Measure	Oxycodone/Naloxone n=72 participants at risk Targin(Oxycodone/Naloxone) Targin: Single arm for Targin
Nervous system disorders Dizziness	20.8% 15/72 • Number of events 17 • 4weeks
Nervous system disorders Somnolence	5.6% 4/72 • Number of events 4 • 4weeks
Nervous system disorders Hypersomnia	1.4% 1/72 • Number of events 1 • 4weeks
Nervous system disorders Lethargy	1.4% 1/72 • Number of events 1 • 4weeks
Gastrointestinal disorders Nausea	9.7% 7/72 • Number of events 7 • 4weeks
Gastrointestinal disorders Diarrhoea	1.4% 1/72 • Number of events 1 • 4weeks
Gastrointestinal disorders Constipation	4.2% 3/72 • Number of events 3 • 4weeks
Gastrointestinal disorders Vomiting	5.6% 4/72 • Number of events 4 • 4weeks
Gastrointestinal disorders Dyspepsia	1.4% 1/72 • Number of events 1 • 4weeks
General disorders Fatigue	1.4% 1/72 • Number of events 1 • 4weeks
General disorders Asthenia	1.4% 1/72 • Number of events 1 • 4weeks
General disorders Malaise	1.4% 1/72 • Number of events 1 • 4weeks
General disorders Oedema	1.4% 1/72 • Number of events 1 • 4weeks
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 1/72 • Number of events 1 • 4weeks
Skin and subcutaneous tissue disorders Hyperhidrosis	1.4% 1/72 • Number of events 1 • 4weeks
Cardiac disorders Palpitations	1.4% 1/72 • Number of events 1 • 4weeks
Metabolism and nutrition disorders Decreased appetite	1.4% 1/72 • Number of events 1 • 4weeks
Renal and urinary disorders Dysuria	1.4% 1/72 • Number of events 1 • 4weeks

Additional Information

Jin-Hyong Kang

Seoul ST.Mary's Hospital

Phone: 82-2-2258-6043

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place