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

• 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: Mundipharma Research GmbH & Co KG
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Placebo Tablets	OXN PR Tablet	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Short Form McGill Pain Score.
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Tablets	OXN PR Tablet
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)

Adverse Events

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
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	--/--		--/--
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.
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

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: info@contact-clinical-trials.com

• Responsible Party: Mundipharma Research GmbH & Co KG
• ClinicalTrials.gov Identifier: NCT00944697
• 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