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Trial record 11 of 20 for:    2502 AND dose

A Study to Demonstrate the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Addition to Pregabalin Compared to Pregabalin Alone in Opioid-naïve Subjects Treated With Pregabalin Suffering From Moderate to Severe Pain Due to Diabetic Polyneuropathy

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ClinicalTrials.gov Identifier: NCT00944697
Recruitment Status : Completed
First Posted : July 23, 2009
Results First Posted : February 28, 2012
Last Update Posted : August 17, 2012
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research GmbH & Co KG

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Moderate to Severe Pain Due to Diabetic Polyneuropathy
Interventions Drug: Oxycodone Naloxone
Drug: Placebo tablets
Enrollment 98
Recruitment Details Recruitment was 13 July 2009 to 26 March 2010. There were 29 sites in General Practice, hospitals and SMOs.
Pre-assignment Details Patients had to have moderate to severe pain due to diabetic/idiopathic polyneuropathy. This was shown by a pain score of >= 5 (average pain over 24 hours)and an MNSI (Michigan Neuropathy Screening Instrument) of >= 2.5 at screening. Subjects were then randomised to OXN (Oxycodone/Naloxone) or placebo.
Arm/Group Title Placebo Tablets OXN PR Tablet
Hide Arm/Group Description A placebo tablet to match the active reference treatment Oxycodone Naloxone Prolonged Release (OXN PR) tablets
Period Title: Overall Study
Started 50 48
Completed 48 43
Not Completed 2 5
Reason Not Completed
Withdrawal by Subject             1             1
Adverse Event             0             3
Administrative             1             1
Arm/Group Title Placebo Tablets OXN PR Tablet Total
Hide Arm/Group Description A placebo tablet to match the active reference treatment Oxycodone Naloxone Prolonged Release (OXN PR) tablets Total of all reporting groups
Overall Number of Baseline Participants 50 48 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 98 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
32
  64.0%
35
  72.9%
67
  68.4%
>=65 years
18
  36.0%
13
  27.1%
31
  31.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 48 participants 98 participants
62.24  (9.39) 58.96  (10.03) 60.63  (9.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 98 participants
Female
23
  46.0%
25
  52.1%
48
  49.0%
Male
27
  54.0%
23
  47.9%
50
  51.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 98 participants
Czech Republic 21 19 40
Germany 7 7 14
Hungary 11 11 22
Romania 11 11 22
1.Primary Outcome
Title Short Form McGill Pain Score.
Hide Description The McGill Pain Score is the sum of the answers to three questions: A - describe your pain during the last week, 15 descriptors, (from 0 to 45 total), B – rate your pain during the last week (from 0 to 100), C: present pain intensity (0 to 5). Total pain score will be out of 150, with 0 being least pain and 150 being most pain.
Time Frame Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tablets OXN PR Tablet
Hide Arm/Group Description:
A placebo tablet to match the active reference treatment
Oxycodone Naloxone Prolonged Release (OXN PR) tablets
Overall Number of Participants Analyzed 50 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
49.56  (29.62) 47.65  (30.27)
Time Frame From after consent to 7 days after Last Patient Last Visit (105 days)
Adverse Event Reporting Description Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
 
Arm/Group Title Placebo Tablets OXN PR Tablet
Hide Arm/Group Description A placebo tablet to match the active reference treatment Oxycodone Naloxone Prolonged Release (OXN PR) tablets
All-Cause Mortality
Placebo Tablets OXN PR Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Tablets OXN PR Tablet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      4/48 (8.33%)    
Cardiac disorders     
Coronary Artery Disease * 1 [1]  0/50 (0.00%)  0 1/48 (2.08%)  1
Atrial Fibrillation * 1 [2]  0/50 (0.00%)  0 1/48 (2.08%)  1
Infections and infestations     
Cystitis * 1 [3]  0/50 (0.00%)  0 1/48 (2.08%)  1
Wound Abscess * 1 [3]  0/50 (0.00%)  0 1/48 (2.08%)  1
Vascular disorders     
Iliac Artery Stenosis * 1 [4]  0/50 (0.00%)  0 1/48 (2.08%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
[1]
This subject also had an SAE (Serious Adverse Event) of Iliac Artery Stenosis. Unrelated to study drug.
[2]
"Unlikely" relationship to study drug
[3]
Unrelated to study drug.
[4]
This patient also had an SAE (Serious Adverse Event) of Coronary Artery Disease. Unrelated to study drug.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Tablets OXN PR Tablet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/50 (44.00%)      36/48 (75.00%)    
Cardiac disorders     
Cardiac Disorders * 1  0/50 (0.00%)  0 2/48 (4.17%) 
Ear and labyrinth disorders     
Ear and Labyrinth disorder * 1  4/50 (8.00%)  3/48 (6.25%) 
Gastrointestinal disorders     
Gastrointestinal Disorders * 1  10/50 (20.00%)  17/48 (35.42%) 
General disorders     
General Disorders and Administration Site Conditions * 1  1/50 (2.00%)  7/48 (14.58%) 
Hepatobiliary disorders     
Hepatobiliary Disorders * 1  0/50 (0.00%)  0 1/48 (2.08%) 
Infections and infestations     
Infections and Infestations * 1  3/50 (6.00%)  9/48 (18.75%) 
Injury, poisoning and procedural complications     
Injury, Poisoning and Procedural Complications * 1  1/50 (2.00%)  0/48 (0.00%)  0
Investigations     
Investigations * 1  6/50 (12.00%)  6/48 (12.50%) 
Metabolism and nutrition disorders     
Metabolism and Nutrition Disorders * 1  4/50 (8.00%)  3/48 (6.25%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorders * 1  2/50 (4.00%)  0/48 (0.00%)  0
Nervous system disorders     
Nervous System disorders * 1  5/50 (10.00%)  12/48 (25.00%) 
Psychiatric disorders     
Psychiatric Disorders * 1  1/50 (2.00%)  2/48 (4.17%) 
Renal and urinary disorders     
Renal and Urinary Disorders * 1  0/50 (0.00%)  0 1/48 (2.08%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory, Thoracic and mediastinal disorders * 1  1/50 (2.00%)  0/48 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin and subcutaneous tissue disorders * 1  2/50 (4.00%)  4/48 (8.33%) 
Vascular disorders     
Vascular Disorders * 1  0/50 (0.00%)  0 3/48 (6.25%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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 Medical Operations
Organization: Mundipharma Research GmbH
Phone: 44 01223424900
Responsible Party: Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier: NCT00944697     History of Changes
Other Study ID Numbers: OXN2502
2008-005815-17
First Submitted: July 22, 2009
First Posted: July 23, 2009
Results First Submitted: November 22, 2011
Results First Posted: February 28, 2012
Last Update Posted: August 17, 2012