Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Objectives:
Objective of main interest
- To assess the drop-out rate caused by adverse event* after 6 weeks treatment
Further objectives
Study Design (Methodology):
This will be a single center, open-label, randomised, phase IV, exploratory interventional study to compare the efficacy and tolerability of current titration patterns and slow titration pattern with Targin® (Oxycodone/Naloxone) in the treatment of moderate to severe non-malignant chronic pain patients who are dissatisfied with their current analgesic medication World Health Organisation (WHO) step II analgesics).
Upon providing written informed consent, subject will be screened in the study and assessment will be performed at that time such as safety laboratory assessments, physical examination, vital sign, medical history taking, 24 hours pain intensity score. If the patient is eligible in inclusion/exclusion criteria at the time of visit 1, the patient will be randomized in a 1:1 ratio to allocate in Group A or Group B. Re-screening, study drug dose interruption is not allowed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d. |
|
| Group B | Other | Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone/naloxone | Drug | Oxycodone/naloxone titration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment | To assess the drop-out rate caused by adverse event* after 6 weeks treatment | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Drop-out Rate Due to an Adverse Event After 1 Week Treatment With the Study Drug. | The drop-out rate due to an adverse event after treatment (1 week) by treatment arm were summarized and presented as frequency and percentage, and the inter-group difference were compared by using a Chi-square test or Fisher's exact test. | 1 week |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hoseong Lee, Dr. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMC | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Safety set: 261 patients were enrolled. ITT set was 258, 3 patients of the 261 patients deviated from inclusion/exclusion criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Start Oxycodone/Naloxone 10/5mg b.i.d. | Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d. |
| FG001 | Start Oxycodone/Naloxone 5/2.5mg b.i.d | Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety set: 261 ITT set: 258(3 patients were deviated inclusion/exclusion criteria among 261)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Start Oxycodone/Naloxone 10/5mg b.i.d | Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d. |
| BG001 | Start Oxycodone/Naloxone 5/2.5mg b.i.d |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment | To assess the drop-out rate caused by adverse event* after 6 weeks treatment | Intent to treat analysis set: 258 patients (Last Observation Carried Forward) | Posted | Number | percentage of participants | 6 weeks |
|
Safety set: Safety set included data obtained from all subjects who administered at least one dose of the study drug. Patients were followed by 6 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Start Oxycodone/Naloxone 10/5mg b.i.d | Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Duodenal stenosis | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment | They all resolved during the study and they were all evaluated as 'Unrelated' to the study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hoseong Lee | Asan Medical Center | 82-2-3010-3521 | hosng@amc.seoul.kr |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D009270 | Naloxone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| The Change of Pain Intensity Scores(NRS) From Baseline After 6 Weeks Treatment With the Study. |
Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline to 6weeks. NRS score was measured from 0 (No pain) to 10(worst pain imaginable). |
| 6 weeks |
| Change of Quality of Life (EQ-5D) Score After 6 Weeks Treatment With the Study Drug | 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. | 6 weeks |
| Assessment of Investigator's Overall Satisfaction After 6 Weeks Treatment With the Study Drug | Investigator's overall satisfaction after treatment (6 weeks) (Clinical Global Impression of Change Scale(CGIC) 7 point scale) by treatment arm were summarized and presented as frequency and proportion, and the inter-group difference were compared by using a Chi-square test or Fisher's exact test. | 6 weeks |
| Assessment of Subject's Overall Satisfaction After 6 Weeks Treatment With the Study Drug | At each visit, the subject assessed the overall satisfaction for efficacy by using the 7 point scale of Patient Global Impression of Change Scale(PGIC). | 6weeks |
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | The Drop-out Rate Due to an Adverse Event After 1 Week Treatment With the Study Drug. | The drop-out rate due to an adverse event after treatment (1 week) by treatment arm were summarized and presented as frequency and percentage, and the inter-group difference were compared by using a Chi-square test or Fisher's exact test. | Intent to treat analysis set: 258(Last observation Carried Forward) | Posted | Number | percentage of participants | 1 week |
|
|
|
| Secondary | The Change of Pain Intensity Scores(NRS) From Baseline After 6 Weeks Treatment With the Study. | Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline to 6weeks. NRS score was measured from 0 (No pain) to 10(worst pain imaginable). | ITT analysis set: 258 | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| Secondary | Change of Quality of Life (EQ-5D) Score After 6 Weeks Treatment With the Study Drug | 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. | ITT analysis set. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| Secondary | Assessment of Investigator's Overall Satisfaction After 6 Weeks Treatment With the Study Drug | Investigator's overall satisfaction after treatment (6 weeks) (Clinical Global Impression of Change Scale(CGIC) 7 point scale) by treatment arm were summarized and presented as frequency and proportion, and the inter-group difference were compared by using a Chi-square test or Fisher's exact test. | ITT analysis set: 171. Last visit(Visit 5) data was handled as LOCF. However, Missing Number as visit 3 for assessment of Investigator's overall satisfaction after 6 weeks treatment with the study drug was Group A = 50, Group B=37. | Posted | Number | participants | 6 weeks |
|
|
|
| Secondary | Assessment of Subject's Overall Satisfaction After 6 Weeks Treatment With the Study Drug | At each visit, the subject assessed the overall satisfaction for efficacy by using the 7 point scale of Patient Global Impression of Change Scale(PGIC). | ITT analysis set: 171. Last visit(Visit 5) data was handled as LOCF. However, Missing Number as visit 3 for assessment of Investigator's overall satisfaction after 6 weeks treatment with the study drug was Group A = 50, Group B=37. | Posted | Number | participants | 6weeks |
|
|
|
| 0 |
| 133 |
| 115 |
| 133 |
| EG001 | Start Oxycodone/Naloxone 5/2.5mg b.i.d | Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d. | 2 | 128 | 104 | 128 |
|
| Inflammation | General disorders | MedDRA (15.1) | Systematic Assessment | system organ class: General disorders and administration site conditions |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Duodenal stenosis | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Mental impairment | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Essential tremor | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (15.1) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (15.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (15.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (15.1) | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA (15.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (15.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (15.1) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
|
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA (15.1) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (15.1) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (15.1) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (15.1) | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
|
| Hyperaemia | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
|
Not provided
Not provided
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Minimally improved |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| very much worse |
|
| Minimally improved |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|