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Immediate-Release Oxycodone Capsules Study in Cancer Pain

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ClinicalTrials.gov Identifier: NCT01675622
Recruitment Status : Completed
First Posted : August 30, 2012
Results First Posted : May 21, 2018
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Mundipharma (China) Pharmaceutical Co. Ltd

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cancer
Interventions Drug: Oxycodone
Drug: Morphine
Enrollment 242
Recruitment Details A total of 242 subjects were enrolled from 20 centers in which 192 subjects completed the study and 50 subjects did not completed the study. All the subjects were recruited from medical clinic.The recruitment period is from 2011 Jan to 2012 Mar.
Pre-assignment Details Patients with moderate to severe cancer pain requiring oral opioid therapy were screened. All the patients who meets the inclusion/exclusion criteria were enrolled to double blind treatment phase. No wash our or run-in period required by protocol.
Arm/Group Title Oxycodone Capsules for Cancer Pain Morphine Tablets for Cancer Pain
Hide Arm/Group Description

Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days. All patients completed the double-blind treatment entered into period 2.

period 2 is open treatment phase. Patients received two weeks treatment of oxycodone hydrochloride controlled-release tablets.

Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours. All patients completed the double-blind treatment entered into period 2.

period 2 is open treatment phase. Patients received two weeks treatment of oxycodone hydrochloride controlled-release tablets.

Period Title: Overall Study
Started 122 120
Completed 96 96
Not Completed 26 24
Reason Not Completed
Withdrawal by Subject             2             2
Adverse Event             12             10
Protocol Violation             4             1
Lack of Efficacy             2             4
Lost to Follow-up             1             3
not specified             5             4
Arm/Group Title Oxycodone Capsules for Cancer Pain Morphine Tablets for Cancer Pain Total
Hide Arm/Group Description Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours Total of all reporting groups
Overall Number of Baseline Participants 120 118 238
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 118 participants 238 participants
56.62  (12.96) 57.05  (12.07) 56.83  (12.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 118 participants 238 participants
Female
58
  48.3%
59
  50.0%
117
  49.2%
Male
62
  51.7%
59
  50.0%
121
  50.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 118 participants 238 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
119
  99.2%
117
  99.2%
236
  99.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
1
   0.8%
1
   0.8%
2
   0.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
China Number Analyzed 120 participants 118 participants 238 participants
120
 100.0%
118
 100.0%
238
 100.0%
height  
Mean (Standard Deviation)
Unit of measure:  Centimeter
Number Analyzed 120 participants 118 participants 238 participants
164.5  (7.45) 164.99  (8.20) 164.74  (7.82)
weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 120 participants 118 participants 238 participants
58.64  (10.79) 58.34  (11.01) 58.49  (10.88)
1.Primary Outcome
Title Numerical Rating Scale (NRS)
Hide Description The numerical rating scale is the tool to assess pain level using a numerical rating scale. The primary outcome measurement is the average change of NRS score after double blind treatment between the two treatment groups. The NRS evaluates the pain level using number scale from 0 to 10. 0 means not painful and 10 means extremely painful. 1 to 3 is lightly pain, 4-6 is moderate pain and 7 to 10 is severe pain. There is no subscales used for NRS reporting.
Time Frame baseline up to 5-8 days (double blind period)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone Capsules for Cancer Pain Morphine Tablets for Cancer Pain
Hide Arm/Group Description:
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
Overall Number of Participants Analyzed 120 118
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.91  (2.31) 3.87  (2.22)
2.Secondary Outcome
Title The Average Dose of Study Medicine Used During Double Blind Treatment Period
Hide Description the average dose of study medicine used during double blind treatment period between the two treatment groups.
Time Frame baseline up to 5-8 days (double blind period)
Hide Outcome Measure Data
Hide Analysis Population Description
The average total dosage during double-blind treatment was defined as a primary efficacy endpoint in the protocol, but this study was a non-inferiority study, and non-inferiority analysis could not be performed in average total dosage in data processing and statistics.
Arm/Group Title Oxycodone Capsules for Cancer Pain Morphine Tablets for Cancer Pain
Hide Arm/Group Description:
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
Overall Number of Participants Analyzed 120 118
Mean (Standard Deviation)
Unit of Measure: mg
Average total dosage during double-blind titration 83.29  (82.87) 141.61  (112.10)
Ave. total dosage during double-blind maintenance 167.41  (103.92) 308.63  (189.93)
3.Secondary Outcome
Title Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period
Hide Description The secondary outcome measurement is the change between BPI score at baseline and after completion of double blind treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in the passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items.
Time Frame baseline up to 5-8 days (double blind period)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone Capsules for Cancer Pain Morphine Tablets for Cancer Pain
Hide Arm/Group Description:
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
Overall Number of Participants Analyzed 120 118
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Highest pain intensity in 24 hrs 4.25  (1.98) 4.03  (2.20)
Lowest pain intensity in 24 hrs 2.62  (2.08) 2.53  (1.98)
Average pain intensity in 24 hrs 3.39  (1.80) 3.35  (1.73)
Current Pain intensity 3.78  (1.94) 3.70  (1.88)
4.Secondary Outcome
Title Times of Breakthrough Pain Occurrence
Hide Description the times of breakthrough pain occurrence during double blind treatment phase between the two treatment groups
Time Frame Within 8 days after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone Capsules for Cancer Pain Morphine Tablets for Cancer Pain
Hide Arm/Group Description:
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
Overall Number of Participants Analyzed 120 118
Measure Type: Number
Unit of Measure: breakthrough pain events
15 20
5.Secondary Outcome
Title Patient Assessments of Satisfaction for Pain Management
Hide Description the number of patients of satisfaction for pain management between the two treatment groups at the end of double blind treatment and the open label treatment period.
Time Frame baseline up to 19-22 days (open label treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone Capsules for Cancer Pain Morphine Tablets for Cancer Pain
Hide Arm/Group Description:
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
Overall Number of Participants Analyzed 120 118
Measure Type: Count of Participants
Unit of Measure: Participants
Very satisfied
35
  29.2%
37
  31.4%
Satisfied
64
  53.3%
61
  51.7%
Neutral
9
   7.5%
5
   4.2%
Dissatisfied
1
   0.8%
4
   3.4%
Missing
11
   9.2%
11
   9.3%
6.Secondary Outcome
Title Average Number of Titrations
Hide Description the average times to change the dose in order to find the proper dose between two treatment groups
Time Frame baseline up to 1-3 days(double blind period)
Hide Outcome Measure Data
Hide Analysis Population Description
Dosing change frequency for complete titration
Arm/Group Title Oxycodone Capsules for Cancer Pain Morphine Tablets for Cancer Pain
Hide Arm/Group Description:
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
Overall Number of Participants Analyzed 120 118
Mean (Standard Deviation)
Unit of Measure: dose changes
8.25  (4.52) 7.89  (3.43)
7.Secondary Outcome
Title Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment
Hide Description The secondary outcome measurement is the change of BPI score from baseline to the end of open label treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items.
Time Frame baseline up to 19-22 days (open label treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone Capsules for Cancer Pain Morphine Tablets for Cancer Pain
Hide Arm/Group Description:
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
Overall Number of Participants Analyzed 120 118
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Highest pain intensity in 24 hrs 3.98  (2.09) 3.95  (1.92)
Lowest pain intensity in 24 hrs 2.57  (2.05) 2.64  (1.98)
Average pain intensity in 24 hrs 3.33  (1.83) 3.48  (1.57)
Current Pain intensity 3.62  (1.87) 3.71  (1.57)
8.Secondary Outcome
Title the Total Dose of Rescue Medicine for Breakthrough Pain.
Hide Description the total dose of rescue medicine for breakthrough pain during double blind phase between the two treatment groups
Time Frame baseline up to 22 days (double blind period)
Hide Outcome Measure Data
Hide Analysis Population Description
The double-blind titration period was the dose adjusting phase, so breakthrough pain occurrences in this period were not included in statistical analysis. After titration was completed, subjects entered into maintenance treatment with the titrated dose.
Arm/Group Title Oxycodone Capsules for Cancer Pain Morphine Tablets for Cancer Pain
Hide Arm/Group Description:
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
Overall Number of Participants Analyzed 120 118
Mean (Standard Deviation)
Unit of Measure: mg
the total dose of rescue medicine -day1 10.63  (7.76) 7.00  (4.83)
the total dose of rescue medicine -day2 10.00  (8.29) 6.00  (2.07)
the total dose of rescue medicine-day3 10.63  (8.21) 6.82  (2.52)
the total dose of rescue medicine-day4 20.00  (8.94) 7.86  (3.93)
the total dose of rescue medicine-day5 11.00  (10.84) 6.67  (4.08)
the total dose of rescue medicine -day6 0  (0) 5.00  (0.00)
the total dose of rescue medicine after day6 5.00  (0) 5.00  (0.00)
9.Secondary Outcome
Title Degree of Pain Relief Within 24hrs After Treatment
Hide Description Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period. The BPI is the average number of above 4 BPI Pain Items. For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).
Time Frame baseline up to 5-8 days (double blind period)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone Capsules for Cancer Pain Morphine Tablets for Cancer Pain
Hide Arm/Group Description:
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
Overall Number of Participants Analyzed 120 118
Mean (Standard Deviation)
Unit of Measure: percentage of pain relief
35.23  (28.27) 34.19  (30.85)
10.Secondary Outcome
Title Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment
Hide Description For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).
Time Frame baseline up to 19-22 days (open label treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxycodone Capsules for Cancer Pain Morphine Tablets for Cancer Pain
Hide Arm/Group Description:
Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
Overall Number of Participants Analyzed 120 118
Mean (Standard Deviation)
Unit of Measure: percentage of pain relief
32.31  (30.80) 31.64  (29.73)
Time Frame up to 36 days
Adverse Event Reporting Description The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.
 
Arm/Group Title Oxycodone Capsules for Cancer Pain Morphine Tablets for Cancer Pain
Hide Arm/Group Description Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours
All-Cause Mortality
Oxycodone Capsules for Cancer Pain Morphine Tablets for Cancer Pain
Affected / at Risk (%) Affected / at Risk (%)
Total   2/120 (1.67%)      2/118 (1.69%)    
Show Serious Adverse Events Hide Serious Adverse Events
Oxycodone Capsules for Cancer Pain Morphine Tablets for Cancer Pain
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/120 (3.33%)      2/118 (1.69%)    
Gastrointestinal disorders     
ileus * [1]  1/120 (0.83%)  1 0/118 (0.00%)  0
Nervous system disorders     
Brain metastases * [2]  1/120 (0.83%)  1 0/118 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory and circulatory failure * [3]  2/120 (1.67%)  2 2/118 (1.69%)  2
*
Indicates events were collected by non-systematic assessment
[1]
1 patient had ileus, which was possibly related to the study drug determined by the investigator, and the associated symptoms completely disappeared at the end of follow-up period.
[2]
1 patient was hospitalized for brain metastases, which was unrelated to the study drug determined by the investigator, and the associated symptoms still persisted at the end of follow-up period;
[3]
4 patients died of respiratory/circulatory failure due to progression of the underlying disease, which were not related to the study drug determined by the investigator
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.0%
Oxycodone Capsules for Cancer Pain Morphine Tablets for Cancer Pain
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   76/120 (63.33%)      75/118 (63.56%)    
Blood and lymphatic system disorders     
Anemia *  3/120 (2.50%)  3 1/118 (0.85%)  1
Low platelet count *  3/120 (2.50%)  3 0/118 (0.00%)  0
Hypertension *  3/120 (2.50%)  3 1/118 (0.85%)  1
Gastrointestinal disorders     
Constipation *  38/120 (31.67%)  41 43/118 (36.44%)  47
Nausea *  25/120 (20.83%)  31 26/118 (22.03%)  30
Vomiting *  25/120 (20.83%)  27 24/118 (20.34%)  25
Diarrhea *  4/120 (3.33%)  4 2/118 (1.69%)  2
Immune system disorders     
Fever *  8/120 (6.67%)  9 4/118 (3.39%)  6
Nervous system disorders     
Dizziness *  9/120 (7.50%)  10 6/118 (5.08%)  6
Drowsiness *  8/120 (6.67%)  8 4/118 (3.39%)  4
Loss of appetite *  5/120 (4.17%)  5 3/118 (2.54%)  3
Psychiatric disorders     
Fatigue *  4/120 (3.33%)  4 2/118 (1.69%)  2
Renal and urinary disorders     
Dysuria *  3/120 (2.50%)  3 6/118 (5.08%)  6
Respiratory, thoracic and mediastinal disorders     
Cough *  4/120 (3.33%)  4 4/118 (3.39%)  4
Pulmonary infection *  3/120 (2.50%)  3 4/118 (3.39%)  4
Dyspnea *  3/120 (2.50%)  3 1/118 (0.85%)  1
*
Indicates events were collected by non-systematic assessment
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
Name/Title: Director of R&D
Organization: Mundipharma (China) phamaceutical CO. LTD
Phone: 0086-10-65636800
Responsible Party: Mundipharma (China) Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT01675622     History of Changes
Other Study ID Numbers: OXYC10-CN-303
First Submitted: April 25, 2012
First Posted: August 30, 2012
Results First Submitted: November 17, 2017
Results First Posted: May 21, 2018
Last Update Posted: May 21, 2018