Trial Outcomes & Findings for 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 (NCT NCT00944697)

Last Updated: 2012-08-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

98 participants

Primary outcome timeframe

Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal)

Results posted on

2012-08-17

Participant Flow

Recruitment was 13 July 2009 to 26 March 2010. There were 29 sites in General Practice, hospitals and SMOs.

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.

Participant milestones

Participant milestones
Measure	Placebo Tablets A placebo tablet to match the active reference treatment	OXN PR Tablet Oxycodone Naloxone Prolonged Release (OXN PR) tablets
Overall Study STARTED	50	48
Overall Study COMPLETED	48	43
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Tablets A placebo tablet to match the active reference treatment	OXN PR Tablet Oxycodone Naloxone Prolonged Release (OXN PR) tablets
Overall Study Withdrawal by Subject	1	1
Overall Study Adverse Event	0	3
Overall Study Administrative	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Tablets n=50 Participants A placebo tablet to match the active reference treatment	OXN PR Tablet n=48 Participants Oxycodone Naloxone Prolonged Release (OXN PR) tablets	Total n=98 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	35 Participants n=7 Participants	67 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	13 Participants n=7 Participants	31 Participants n=5 Participants
Age Continuous	62.24 years STANDARD_DEVIATION 9.39 • n=5 Participants	58.96 years STANDARD_DEVIATION 10.03 • n=7 Participants	60.63 years STANDARD_DEVIATION 9.80 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	23 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment Czech Republic	21 participants n=5 Participants	19 participants n=7 Participants	40 participants n=5 Participants
Region of Enrollment Germany	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment Hungary	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants
Region of Enrollment Romania	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal)

Outcome measures

Outcome measures
Measure	Placebo Tablets n=50 Participants A placebo tablet to match the active reference treatment	OXN PR Tablet n=46 Participants Oxycodone Naloxone Prolonged Release (OXN PR) tablets
Short Form McGill Pain Score.	49.56 units on a scale Standard Deviation 29.62	47.65 units on a scale Standard Deviation 30.27

Adverse Events

Placebo Tablets

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

OXN PR Tablet

Serious events: 4 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Tablets n=50 participants at risk A placebo tablet to match the active reference treatment	OXN PR Tablet n=48 participants at risk Oxycodone Naloxone Prolonged Release (OXN PR) tablets
Cardiac disorders Coronary Artery Disease	0.00% 0/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	2.1% 1/48 • Number of events 1 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
Vascular disorders Iliac Artery Stenosis	0.00% 0/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	2.1% 1/48 • Number of events 1 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
Infections and infestations Cystitis	0.00% 0/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	2.1% 1/48 • Number of events 1 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
Infections and infestations Wound Abscess	0.00% 0/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	2.1% 1/48 • Number of events 1 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
Cardiac disorders Atrial Fibrillation	0.00% 0/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	2.1% 1/48 • Number of events 1 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.

Other adverse events

Additional Information

Director of Medical Operations

Mundipharma Research GmbH

Phone: 44 01223424900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo Tablets n=50 participants at risk A placebo tablet to match the active reference treatment	OXN PR Tablet n=48 participants at risk Oxycodone Naloxone Prolonged Release (OXN PR) tablets
Cardiac disorders Cardiac Disorders	0.00% 0/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	4.2% 2/48 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
Ear and labyrinth disorders Ear and Labyrinth disorder	8.0% 4/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	6.2% 3/48 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
Gastrointestinal disorders Gastrointestinal Disorders	20.0% 10/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	35.4% 17/48 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
General disorders General Disorders and Administration Site Conditions	2.0% 1/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	14.6% 7/48 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
Hepatobiliary disorders Hepatobiliary Disorders	0.00% 0/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	2.1% 1/48 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
Infections and infestations Infections and Infestations	6.0% 3/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	18.8% 9/48 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
Injury, poisoning and procedural complications Injury, Poisoning and Procedural Complications	2.0% 1/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	0.00% 0/48 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
Investigations Investigations	12.0% 6/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	12.5% 6/48 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
Metabolism and nutrition disorders Metabolism and Nutrition Disorders	8.0% 4/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	6.2% 3/48 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	4.0% 2/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	0.00% 0/48 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
Nervous system disorders Nervous System disorders	10.0% 5/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	25.0% 12/48 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
Psychiatric disorders Psychiatric Disorders	2.0% 1/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	4.2% 2/48 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
Renal and urinary disorders Renal and Urinary Disorders	0.00% 0/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	2.1% 1/48 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic and mediastinal disorders	2.0% 1/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	0.00% 0/48 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	4.0% 2/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	8.3% 4/48 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.
Vascular disorders Vascular Disorders	0.00% 0/50 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.	6.2% 3/48 • From after consent to 7 days after Last Patient Last Visit (105 days) Screening phase = 14 days, Treatment for 12 weeks (84 days) and 7 day follow up.