Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 44 of 663 for:    OXYCODONE

A Study to Compare Oxycodone/Naloxone Prolonged Release Against Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis

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: NCT00784810
Recruitment Status : Completed
First Posted : November 4, 2008
Results First Posted : November 2, 2011
Last Update Posted : November 2, 2011
Sponsor:
Information provided by (Responsible Party):
Napp Pharmaceuticals Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Osteoarthritis
Back Pain
Interventions Drug: Oxycodone/Naloxone
Drug: Codeine/Paracetamol
Enrollment 247
Recruitment Details Patients were recruited in primary and secondary care in the UK from 6 Feb 2009 to 24 Mar 2010
Pre-assignment Details 3-7 day screening, following 7-14 day run-in and a 12 week double-blind treatment period.
Arm/Group Title Oxycodone/Naloxone Tablets (OXN) Codeine/Paracetamol Tablets
Hide Arm/Group Description Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg Codeine/Paracetamol 15/500 and 30/500 mg
Period Title: Overall Study
Started 124 123
Completed 61 74
Not Completed 63 49
Reason Not Completed
Adverse Event             32             20
Lack of Efficacy             14             11
Withdrawal by Subject             11             9
Administrative             5             8
Lost to Follow-up             1             1
Arm/Group Title Oxycodone/Naloxone Tablets (OXN) Codeine/Paracetamol Tablets Total
Hide Arm/Group Description Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg Codeine/Paracetamol 15/500 and 30/500 mg Total of all reporting groups
Overall Number of Baseline Participants 124 123 247
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 123 participants 247 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
66
  53.2%
70
  56.9%
136
  55.1%
>=65 years
58
  46.8%
53
  43.1%
111
  44.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 124 participants 123 participants 247 participants
64.3  (10.53) 63.9  (10.97) 64.1  (10.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 123 participants 247 participants
Female
77
  62.1%
81
  65.9%
158
  64.0%
Male
47
  37.9%
42
  34.1%
89
  36.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 124 participants 123 participants 247 participants
124 123 247
1.Primary Outcome
Title Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours)
Hide Description The primary objective was to demonstrate non inferiority of Oxycodone/Naloxone Prolonged Release (OXN PR) compared to codeine/paracetamol in moderate to severe pain as assessed by BS-11 average daily pain scores. The Box Scale-11 is a scale from 0 to 10 (i.e. 0, 1, 2...10), where the subject records their daily pain over the previous 24 hours, by circling the relevant box, where 0 = no pain and 10 = pain as bad as you can imagine. This value is the value recorded at week 12 (average pain over the last 24 hours)
Time Frame Average daily pain over last 24 hours (at Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
To achieve a study with 80% power at the 1-sided 5% sig level and define non-inferiority to be a relative different less than 1.2. A sample size of 98 subjects per treatment group was required, ie a total of 196 subjects completing the study. The lower number of participants is due to subject withdrawal or lack of data.
Arm/Group Title Oxycodone/Naloxone Tablets (OXN) Codeine/Paracetamol Tablets
Hide Arm/Group Description:
Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
Codeine/Paracetamol 15/500 and 30/500 mg
Overall Number of Participants Analyzed 60 80
Mean (Standard Deviation)
Unit of Measure: Units on a BS-11 scale at Week 12
4.2  (2.139) 4.64  (2.046)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxycodone/Naloxone Tablets (OXN), Codeine/Paracetamol Tablets
Comments To achieve a study with 80% power at the 1-sided 5% significance level, for the purposes of demonstrating non inferiority, a sample size of 98 subjects per treatment group was required, i.e. a total of 196 subjects completing the study.
Type of Statistical Test Non-Inferiority or Equivalence
Comments As above.
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.44
Confidence Interval (1-Sided) 90%
-5.65
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.19
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups.
Hide Description To compare the number of intakes of rescue medication use (ibuprofen) for breakthrough pain between OXN (Oxycodone/Naloxone) and codeine/paracetamol groups. Ibuprofen tablets (400mg up to 3 times per day) were available as rescue medication. This was recorded by the subject in their diary whenever it was taken. The discrepancy in numbers of patients at this stage (between Visit 8 and Visit 9) is due to subject withdrawal during the study. The mean values presented are the "number of intakes of rescue medication" for this period (ie between Visit 8 and Visit 9).
Time Frame Between visit 8 and 9
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis is less due to subject withdrawals or lack of data.
Arm/Group Title Oxycodone/Naloxone Tablets (OXN) Codeine/Paracetamol Tablets
Hide Arm/Group Description:
Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg
Codeine/Paracetamol 15/500 and 30/500 mg
Overall Number of Participants Analyzed 60 80
Mean (Standard Deviation)
Unit of Measure: Number of rescue medication intakes
13.2  (23.31) 9.4  (19.94)
Time Frame approximately 3 - 4 months, treatment and outcome
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oxycodone/Naloxone Tablets (OXN) Codeine/Paracetamol Tablets
Hide Arm/Group Description Oxycodone/Naloxone (OXN) tablets 5,10 and 20 mg Codeine/Paracetamol 15/500 and 30/500 mg
All-Cause Mortality
Oxycodone/Naloxone Tablets (OXN) Codeine/Paracetamol Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Oxycodone/Naloxone Tablets (OXN) Codeine/Paracetamol Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/124 (2.42%)      4/123 (3.25%)    
Blood and lymphatic system disorders     
Deep vein thrombosis * 1  0/124 (0.00%)  0 1/123 (0.81%)  1
Cardiac disorders     
carotid artery stenosis * 1  1/124 (0.81%)  1 0/123 (0.00%)  0
Atrial fibrillation * 1  0/124 (0.00%)  0 1/123 (0.81%)  1
Angina Pectoris * 1  0/124 (0.00%)  0 1/123 (0.81%)  2
Gastrointestinal disorders     
diarrhoea, rectal haemorrhage, abdominal pain * 1  1/124 (0.81%)  1 0/123 (0.00%)  0
General disorders     
Head injfury * 1  0/124 (0.00%)  0 1/123 (0.81%)  1
Musculoskeletal and connective tissue disorders     
joint effusion * 1  1/124 (0.81%)  1 0/123 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Oxycodone/Naloxone Tablets (OXN) Codeine/Paracetamol Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/124 (21.77%)      32/123 (26.02%)    
Gastrointestinal disorders     
Constipation * 1  8/124 (6.45%)  7/123 (5.69%) 
dyspepsia * 1  4/124 (3.23%)  6/123 (4.88%) 
nausea * 1  4/124 (3.23%)  3/123 (2.44%) 
haemorrhoids * 1  0/124 (0.00%)  4/123 (3.25%) 
Infections and infestations     
lower respiratory tract infection * 1  7/124 (5.65%)  4/123 (3.25%) 
urinary tract infection * 1  2/124 (1.61%)  5/123 (4.07%) 
bronchitis * 1  2/124 (1.61%)  3/123 (2.44%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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: Director of Medical Affairs
Organization: Napp Pharmaceuticals Ltd
Phone: 01223 424444
Layout table for additonal information
Responsible Party: Napp Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT00784810     History of Changes
Other Study ID Numbers: OXN4502 (2008-002426-10)
First Submitted: November 3, 2008
First Posted: November 4, 2008
Results First Submitted: July 14, 2011
Results First Posted: November 2, 2011
Last Update Posted: November 2, 2011