Trial Outcomes & Findings for An Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Spinal Disorders (NCT NCT01811238)

Last Updated: 2016-05-12

Results Overview

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 Week 8/ET minus mean score at Baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

240 participants

Primary outcome timeframe

Baseline, 8 week

Results posted on

2016-05-12

Participant Flow

The 10 general hospitals were recruited patients from 26 Sep. 2012 to 02 Aug. 2013.

Participant milestones

Participant milestones
Measure	Oxycodone/Naloxone Single-arm study Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone
Overall Study STARTED	240
Overall Study Safety Set	220
Overall Study ITT Set	209
Overall Study PP Set	120
Overall Study COMPLETED	159
Overall Study NOT COMPLETED	81

Reasons for withdrawal

Reasons for withdrawal
Measure	Oxycodone/Naloxone Single-arm study Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone
Overall Study Withdrawal by Subject	42
Overall Study Adverse Event	25
Overall Study Protocol Violation	4
Overall Study Lack of Efficacy	4
Overall Study subject refused study medication	6

Baseline Characteristics

An Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Spinal Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxycodone/Naloxone n=220 Participants Single-arm study Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone
Age, Continuous	62.25 years STANDARD_DEVIATION 10.42 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	86 Participants n=5 Participants
Age, Categorical >=65 years	134 Participants n=5 Participants
Sex: Female, Male Female	136 Participants n=5 Participants
Sex: Female, Male Male	84 Participants n=5 Participants
Region of Enrollment Korea, Republic of	220 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 8 week

Population: The 209 is IIT set population. ITT set included all subjects who participated in the study and had at least one dose of the study drug and had at least one primary efficacy endpoint data available. Missing values were imputed by LOCF.

Outcome measures

Outcome measures
Measure	Oxycodone/Naloxone n=209 Participants Single-arm study Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone
Change From Baseline in Pain Intensity of Patient With Spinal Disorder as Measured by NRS.	-1.69 scores on a scale Standard Deviation 2.18

SECONDARY outcome

Timeframe: Baseline, 8 week

Population: ITT set included all subjects who participated in the study and had at least one dose of the study drug and had at least one primary efficacy endpoint data available.Missing values were imputed by LOCF.

EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)). Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2) \*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents) EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by "1" means that the healthy condition and high quality of life.

Outcome measures

Outcome measures
Measure	Oxycodone/Naloxone n=209 Participants Single-arm study Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone
The Change in Quality of Life (EQ-5D) at Week 8 of Treatment With the Study Drug From Baseline	0.15 scores on a scale Standard Deviation 0.37

SECONDARY outcome

Timeframe: Baseline, 8 week

Population: ITT Population. Below results : Visit 4(8week)(LOCF): n(%)

The number of patients who choose the best opinion of overall satisfaction among Clinical Global Impression of Change Scale(CGIC) among 7 point scale. Missing data was imputed by LOCF. Very much improved much improved minimally improved no change minimally worse much worse very much worse

Outcome measures

Outcome measures
Measure	Oxycodone/Naloxone n=209 Participants Single-arm study Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone
Clinical Global Impression of Change(CGIC) Very much improved	20 participants
Clinical Global Impression of Change(CGIC) Much improved	49 participants
Clinical Global Impression of Change(CGIC) Minimally improved	70 participants
Clinical Global Impression of Change(CGIC) No change	57 participants
Clinical Global Impression of Change(CGIC) Minimally worse	6 participants
Clinical Global Impression of Change(CGIC) much worse	5 participants
Clinical Global Impression of Change(CGIC) Very much worse	2 participants

SECONDARY outcome

Timeframe: Baseline, 4 week

Population: IIT set.

Outcome measures

Outcome measures
Measure	Oxycodone/Naloxone n=209 Participants Single-arm study Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone
Change of Pain Intensity in Patient With Spinal Disorder at Week 4 of Treatment With the Study Drug From Baseline	-1.36 units on a scale Standard Deviation 2.04

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Population: ITT set, Missing values were imputed by LOCF. Difference (Visti 4(8w)-Baseline)

The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' (score = 100) and 'Worst imaginable health state' (score = 0). Higher points were positive results and positive points of difference gap means improvement results.

Outcome measures

Outcome measures
Measure	Oxycodone/Naloxone n=209 Participants Single-arm study Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone
Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)	10.57 scores on a scale Standard Deviation 22.11

SECONDARY outcome

Timeframe: Baseline, 8week

Population: IIT set, Missing values were imputed by LOCF.

Number of participants with categorical change in overall satisfaction. PGIC: a participant-rated instrument assessing change in participant's overall satisfaction from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).

Outcome measures

Outcome measures
Measure	Oxycodone/Naloxone n=209 Participants Single-arm study Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone
Patient Global Impression of Change(PGIC) Very much improved	16 participants
Patient Global Impression of Change(PGIC) Much improved	49 participants
Patient Global Impression of Change(PGIC) Minimally improved	69 participants
Patient Global Impression of Change(PGIC) No change	60 participants
Patient Global Impression of Change(PGIC) Minimally worse	6 participants
Patient Global Impression of Change(PGIC) Much worse	6 participants
Patient Global Impression of Change(PGIC) Very much worse	3 participants

Adverse Events

Oxycodone/Naloxone

Serious events: 3 serious events

Other events: 77 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oxycodone/Naloxone n=220 participants at risk Single-arm study Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone
Musculoskeletal and connective tissue disorders Femur fracture	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Musculoskeletal and connective tissue disorders osteoarthritis	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Renal and urinary disorders Renal cancer	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.

Other adverse events

Other adverse events
Measure	Oxycodone/Naloxone n=220 participants at risk Single-arm study Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone
Gastrointestinal disorders Nausea	9.5% 21/220 • Number of events 21 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Gastrointestinal disorders constipation	5.5% 12/220 • Number of events 12 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Gastrointestinal disorders Dyspepsia	2.7% 6/220 • Number of events 6 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Gastrointestinal disorders Vomiting	2.3% 5/220 • Number of events 5 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Gastrointestinal disorders Abdominal pain	2.3% 5/220 • Number of events 5 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Gastrointestinal disorders Abdominal discomfort	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Gastrointestinal disorders Dry mouth	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Gastrointestinal disorders Gastritis	0.91% 2/220 • Number of events 2 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Gastrointestinal disorders Gastrointestinal disorder	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Nervous system disorders Dizziness	6.4% 14/220 • Number of events 14 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Nervous system disorders Somnolence	2.7% 6/220 • Number of events 6 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Nervous system disorders Headache	1.8% 4/220 • Number of events 4 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Nervous system disorders Parosmia	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Skin and subcutaneous tissue disorders Pruritus	5.0% 11/220 • Number of events 11 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Skin and subcutaneous tissue disorders Urticaria	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
General disorders Oedema peripheral	1.4% 3/220 • Number of events 3 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
General disorders Thirst	0.91% 2/220 • Number of events 2 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
General disorders Face oedema	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
General disorders Oedema	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
General disorders Pain	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Metabolism and nutrition disorders Decreased appetite	3.2% 7/220 • Number of events 7 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Infections and infestations Nasopharyngitis	1.4% 3/220 • Number of events 3 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Infections and infestations Cystitis	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Psychiatric disorders Insomnia	0.91% 2/220 • Number of events 2 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Renal and urinary disorders Dysuria	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Renal and urinary disorders Pollakiuria	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Ear and labyrinth disorders Otorrhoea	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Hepatobiliary disorders Jaundice	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Injury, poisoning and procedural complications Femur fracture	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.45% 1/220 • Number of events 1 • Follow up 8 weeks In the safety set, a total of 120 AEs were reported in 77 subjects (35.0%, 77/220 subjects), regardless of causal relationship to the study drug. Of those, 95 events in 61 subjects (27.7%,61/220 subjects) were ADRs of which causal relationship to the study drug cannot be ruled out.

Additional Information

Dr.Sungsoo Chung

Samsung Medical Center

Phone: 82-3410-1226

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place