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Trial record 61 of 663 for:    OXYCODONE

A Study to Evaluate Efficacy and Safety of Oxycodone/Naloxone Compared to OxyContin in Korean Cancer Patients (TOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01313780
Recruitment Status : Completed
First Posted : March 14, 2011
Results First Posted : October 27, 2016
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Mundipharma Korea Ltd

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cancer
Interventions Drug: Oxycodone/Naloxone
Drug: Oxycodone(single compound)
Enrollment 128
Recruitment Details ITT set(Safety analysis) was 128(64:64) patients, but Missing primary efficacy data: 7 patients, Violation of inclusion/exclusion criteria: 4. So, FAS(Efficacy analysis) set population was 117(oxycodone/naloxone group: 58: Oxycodone: 59).
Pre-assignment Details  
Arm/Group Title Oxycodone and Naloxone Oxycodone
Hide Arm/Group Description Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D. Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
Period Title: Overall Study
Started 58 [1] 59 [1]
Completed 33 [2] 31 [2]
Not Completed 25 28
Reason Not Completed
Lack of Efficacy             4             2
Adverse Event             6             11
Withdrawal by Subject             2             8
Protocol Violation             10             4
missing data             3             3
[1]
FAS
[2]
PPS
Arm/Group Title Oxycodone and Naloxone Oxycodone Total
Hide Arm/Group Description Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D. Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D. Total of all reporting groups
Overall Number of Baseline Participants 58 59 117
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 59 participants 117 participants
<39years 1 3 4
40~49years 7 5 12
50~59years 19 17 36
60~69 years 14 23 37
70~79 years 17 11 28
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 59 participants 117 participants
Female
15
  25.9%
20
  33.9%
35
  29.9%
Male
43
  74.1%
39
  66.1%
82
  70.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 58 participants 59 participants 117 participants
58 59 117
1.Primary Outcome
Title Change of Pain Intensity From Baseline(visit1) to 4weeks.(visit3)
Hide Description Change of pain intensity from 0(No pain) to 10(worst pain imaginable) after 4 weeks treatment .
Time Frame 4weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of FAS: 117.
Arm/Group Title Oxycodone and Naloxone Oxycodone
Hide Arm/Group Description:
Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
Overall Number of Participants Analyzed 58 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.586  (2.217) 1.559  (2.215)
2.Secondary Outcome
Title Change in Bowel Habits.
Hide Description The change of bowel habits from baseline (Visit 1) in bowel habits at Week 4 was investigated, and was categorized as ‘improved’, ‘unchanged’, and ‘worsened’.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS analysis, but Oxycodone/naloxone group was missed 15 patients data and Oxycodone group was missed 23 patients data.
Arm/Group Title Oxycodone and Naloxone Oxycodone
Hide Arm/Group Description:
Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
Overall Number of Participants Analyzed 43 36
Measure Type: Number
Unit of Measure: participants
Unchanged 31 20
worsened 7 11
Improved 5 5
Time Frame 4 weeks
Adverse Event Reporting Description Subjects will be asked to voluntarily report adverse event information any time, and the information will be also checked at phone visits and regular visits during the treatment period through interviews and medical examination by the investigator.
 
Arm/Group Title Oxycodone and Naloxone Oxycodone
Hide Arm/Group Description Oxycodone and naloxone: Trade name is TARGIN. oxycodone : Trade name is Oxycontin
All-Cause Mortality
Oxycodone and Naloxone Oxycodone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Oxycodone and Naloxone Oxycodone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/64 (23.44%)      28/64 (43.75%)    
Blood and lymphatic system disorders     
left neck neoplasm (lymph node)  1  0/64 (0.00%)  0 1/64 (1.56%)  1
leg edema  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Endocrine disorders     
Disorder of adrenal gland  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Gastrointestinal disorders     
aggravated abdominal distension  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Anorexia  1  1/64 (1.56%)  1 1/64 (1.56%)  1
ascitis  1  0/64 (0.00%)  0 1/64 (1.56%)  1
colonic obstruction  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Distension/bloating, abdominal  1  1/64 (1.56%)  1 0/64 (0.00%)  0
protruding mass in oral cavity  1  0/64 (0.00%)  0 1/64 (1.56%)  1
rectal cancer progression  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Vomiting  1  0/64 (0.00%)  0 1/64 (1.56%)  1
worsening vomitting  1  0/64 (0.00%)  0 1/64 (1.56%)  2
General disorders     
Fever  1  1/64 (1.56%)  1 0/64 (0.00%)  0
General condition worse  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Sweating  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Pain  1  1/64 (1.56%)  1 2/64 (3.13%)  2
Pain aggresive  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Hepatobiliary disorders     
cancer progression(gallbladder)  1  1/64 (1.56%)  1 0/64 (0.00%)  0
jaundice  1  0/64 (0.00%)  0 1/64 (1.56%)  1
progress of disease  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Immune system disorders     
anaphylactic shock  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Infections and infestations     
pneumonia  1  2/64 (3.13%)  2 0/64 (0.00%)  0
Investigations     
leukocytosis  1  0/64 (0.00%)  0 1/64 (1.56%)  1
neutropenia  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Thrombocytopenia  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Metabolism and nutrition disorders     
Bilirubin (hyperbilirubinemia)  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Elevation of ALT  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Elevation of AST  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Glucose, serum-low (hypoglycemia)  1  2/64 (3.13%)  2 0/64 (0.00%)  0
Electro imbalance  1  0/64 (0.00%)  0 1/64 (1.56%)  2
Musculoskeletal and connective tissue disorders     
lower extremity weakness  1  0/64 (0.00%)  0 1/64 (1.56%)  2
Rt. Clavicle metasis  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Nervous system disorders     
Anxiety  1  0/64 (0.00%)  0 1/64 (1.56%)  1
both, limb numbness  1  0/64 (0.00%)  0 1/64 (1.56%)  2
delirium  1  1/64 (1.56%)  1 1/64 (1.56%)  1
Dizziness  1  0/64 (0.00%)  0 1/64 (1.56%)  1
hand tremor  1  0/64 (0.00%)  0 1/64 (1.56%)  1
HYPERALGESIA  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Seizure  1  0/64 (0.00%)  0 1/64 (1.56%)  2
somnolence  1  0/64 (0.00%)  0 1/64 (1.56%)  1
headache  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Renal and urinary disorders     
obstruction, ureter  1  1/64 (1.56%)  1 0/64 (0.00%)  0
PCN malfunction  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Urinary retention  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Respiratory, thoracic and mediastinal disorders     
aggravation of lung metastasis  1  0/64 (0.00%)  0 1/64 (1.56%)  1
cancer proression(lung)  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Dyspnea (shortness of breath)  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Pneumonitis/pulmonary infiltrates  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Surgical and medical procedures     
stent insertion site pain  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oxycodone and Naloxone Oxycodone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   55/64 (85.94%)      57/64 (89.06%)    
Blood and lymphatic system disorders     
Anemia  1  2/64 (3.13%)  2 1/64 (1.56%)  1
Anemia  1  1/64 (1.56%)  2 0/64 (0.00%)  0
leukocytosis  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Megablastic anemia  1  1/64 (1.56%)  1 0/64 (0.00%)  0
neutropenia  1  2/64 (3.13%)  2 0/64 (0.00%)  0
Thrombocytopenia  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Epistaxis  1  0/64 (0.00%)  0 1/64 (1.56%)  1
hematochezia  1  2/64 (3.13%)  2 0/64 (0.00%)  0
hemoptysis  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Edema ; both leg  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Edema of legs  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Edema: limb  1  2/64 (3.13%)  3 1/64 (1.56%)  1
left neck neoplasm (lymph node)  1  0/64 (0.00%)  0 1/64 (1.56%)  1
leg edema  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Cardiac disorders     
Hypotension  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Endocrine disorders     
Disorder of adrenal gland  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Gastrointestinal disorders     
Abdominal palpable mass  1  0/64 (0.00%)  0 1/64 (1.56%)  1
aggravated abdominal distension  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Anorexia  1  8/64 (12.50%)  14 4/64 (6.25%)  4
ascitis  1  0/64 (0.00%)  0 1/64 (1.56%)  1
colonic obstruction  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Constipation  1  30/64 (46.88%)  36 35/64 (54.69%)  37
Diarrhea  1  4/64 (6.25%)  4 1/64 (1.56%)  1
Distension/bloating, abdominal  1  1/64 (1.56%)  1 1/64 (1.56%)  1
heartburn  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Heartburn/dyspepsia  1  0/64 (0.00%)  0 3/64 (4.69%)  3
indigestion  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Nausea  1  10/64 (15.63%)  11 18/64 (28.13%)  19
protruding mass in oral cavity  1  0/64 (0.00%)  0 1/64 (1.56%)  1
rectal cancer progression  1  0/64 (0.00%)  0 1/64 (1.56%)  1
reducing oral intake  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Vomiting  1  8/64 (12.50%)  9 7/64 (10.94%)  7
worsening vomitting  1  0/64 (0.00%)  0 1/64 (1.56%)  2
abdominal pain  1  1/64 (1.56%)  1 2/64 (3.13%)  3
Epigastric pain  1  1/64 (1.56%)  1 3/64 (4.69%)  3
oral pain  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Pain ; abdomen  1  0/64 (0.00%)  0 1/64 (1.56%)  1
worsing abdomen pain  1  1/64 (1.56%)  1 0/64 (0.00%)  0
General disorders     
cold sweating  1  1/64 (1.56%)  1 1/64 (1.56%)  1
Fatigue  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Fatigue (asthenia, lethargy, malaise)  1  3/64 (4.69%)  3 3/64 (4.69%)  3
Fever  1  1/64 (1.56%)  1 1/64 (1.56%)  1
General condition worse  1  0/64 (0.00%)  0 1/64 (1.56%)  1
General weakness  1  1/64 (1.56%)  2 0/64 (0.00%)  0
night fever  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Sweating  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Sweating (diaphoresis)  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Weight loss  1  1/64 (1.56%)  2 0/64 (0.00%)  0
Pain aggresive  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Hepatobiliary disorders     
jaundice  1  0/64 (0.00%)  0 1/64 (1.56%)  1
progress of disease  1  1/64 (1.56%)  1 1/64 (1.56%)  1
Immune system disorders     
anaphylactic shock  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Investigations     
Albumin, serum-low (hypoalbuminemia)  1  0/64 (0.00%)  0 1/64 (1.56%)  1
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Bilirubin (hyperbilirubinemia)  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Calcium, serum-high (hypercalcemia)  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Elevated creatininte  1  1/64 (1.56%)  4 0/64 (0.00%)  0
Elevation of ALT  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Elevation of AST  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Glucose, serum-high (hyperglycemia)  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Glucose, serum-low (hypoglycemia)  1  2/64 (3.13%)  5 0/64 (0.00%)  0
Liver enzyme increase  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Potassium, serum-high (hyperkalemia)  1  1/64 (1.56%)  3 1/64 (1.56%)  1
Potassium, serum-low (hypokalemia)  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Sodium, serum-low (hyponatremia)  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Electro imbalance  1  0/64 (0.00%)  0 1/64 (1.56%)  2
Metabolism and nutrition disorders     
hypercalcemia  1  1/64 (1.56%)  1 1/64 (1.56%)  1
Musculoskeletal and connective tissue disorders     
lower extremity weakness  1  0/64 (0.00%)  0 1/64 (1.56%)  2
progress of disease  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Rt. Clavicle metasis  1  1/64 (1.56%)  1 0/64 (0.00%)  0
low back pain  1  0/64 (0.00%)  0 1/64 (1.56%)  1
lt shoulder pain  1  0/64 (0.00%)  0 1/64 (1.56%)  1
lt.knee pain  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Pain  1  1/64 (1.56%)  1 2/64 (3.13%)  2
Pain (Right Upper Quadrant)  1  1/64 (1.56%)  1 0/64 (0.00%)  0
pantalgia  1  0/64 (0.00%)  0 1/64 (1.56%)  1
peivic pain  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Nervous system disorders     
Insomnia  1  3/64 (4.69%)  3 1/64 (1.56%)  1
Anxiety  1  1/64 (1.56%)  1 2/64 (3.13%)  2
both, limb numbness  1  0/64 (0.00%)  0 1/64 (1.56%)  2
Confusion  1  0/64 (0.00%)  0 1/64 (1.56%)  1
delirium  1  1/64 (1.56%)  1 1/64 (1.56%)  1
Dizziness  1  6/64 (9.38%)  7 14/64 (21.88%)  15
hand tremor  1  0/64 (0.00%)  0 1/64 (1.56%)  1
head trauma  1  1/64 (1.56%)  1 0/64 (0.00%)  0
HYPERALGESIA  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Neuropathy: sensory  1  1/64 (1.56%)  1 0/64 (0.00%)  0
peripheral neuropathy  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Sedation  1  0/64 (0.00%)  0 1/64 (1.56%)  2
Seizure  1  0/64 (0.00%)  0 1/64 (1.56%)  2
somnolence  1  3/64 (4.69%)  3 3/64 (4.69%)  3
headache  1  1/64 (1.56%)  1 2/64 (3.13%)  2
Renal and urinary disorders     
cancer progression(gallbladder)  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Urinary tract infection  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Dysuria  1  3/64 (4.69%)  3 3/64 (4.69%)  3
Difficult urination  1  0/64 (0.00%)  0 1/64 (1.56%)  1
obstruction, ureter  1  1/64 (1.56%)  1 0/64 (0.00%)  0
PCN malfunction  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Urinary retention  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Voiding difficulty  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
pneumonia  1  2/64 (3.13%)  2 0/64 (0.00%)  0
Upper respiratory infection  1  2/64 (3.13%)  2 0/64 (0.00%)  0
aggravation of lung metastasis  1  0/64 (0.00%)  0 1/64 (1.56%)  1
cancer proression(lung)  1  0/64 (0.00%)  0 1/64 (1.56%)  1
cough  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Dyspnea  1  1/64 (1.56%)  1 2/64 (3.13%)  2
Dyspnea (shortness of breath)  1  0/64 (0.00%)  0 4/64 (6.25%)  4
Dyspnea on exercise  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Pneumonitis/pulmonary infiltrates  1  1/64 (1.56%)  1 0/64 (0.00%)  0
progress of disease  1  0/64 (0.00%)  0 1/64 (1.56%)  1
sputum  1  1/64 (1.56%)  1 0/64 (0.00%)  0
Skin and subcutaneous tissue disorders     
itching sense(WB)  1  1/64 (1.56%)  2 0/64 (0.00%)  0
Pruritus/itching  1  2/64 (3.13%)  3 3/64 (4.69%)  5
skin lesion on ear  1  1/64 (1.56%)  1 0/64 (0.00%)  0
skin nodule  1  0/64 (0.00%)  0 1/64 (1.56%)  1
whole body itching  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Surgical and medical procedures     
stent insertion site pain  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Infusion related reaction  1  0/64 (0.00%)  0 1/64 (1.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Taewon Kim
Organization: Seoul Asan Hospital
Phone: 82-2-3010-3910
EMail: twkimmd@amc.seoul.kr
Layout table for additonal information
Responsible Party: Mundipharma Korea Ltd
ClinicalTrials.gov Identifier: NCT01313780     History of Changes
Other Study ID Numbers: OXN10-KR-002
First Submitted: March 8, 2011
First Posted: March 14, 2011
Results First Submitted: July 13, 2016
Results First Posted: October 27, 2016
Last Update Posted: December 22, 2017