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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005815-17 |
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To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone.
Study OXN2502 is a pilot, exploratory, randomised, placebo-controlled, double-blind, single-dummy, parallel group study to assess efficacy and safety of OXN PR in addition to a patient's current dose of 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tablets | Placebo Comparator | A placebo tablet to match the active reference treatment |
|
| Tablet | Active Comparator | Oxycodone Naloxone tablets |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone Naloxone | Drug | Oxycodone Naloxone tablets |
| |
| Placebo tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form McGill Pain Score. | 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. | Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal) |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Oliver Emrich | Ludwigshafen | 67069 | Germany |
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| Label | URL |
|---|---|
| Results available on website | View source |
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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.
Recruitment was 13 July 2009 to 26 March 2010. There were 29 sites in General Practice, hospitals and SMOs.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Tablets | A placebo tablet to match the active reference treatment |
| FG001 | OXN PR Tablet | Oxycodone Naloxone Prolonged Release (OXN PR) tablets |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
Placebo Oxycodone Naloxone tablets |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Tablets | A placebo tablet to match the active reference treatment |
| BG001 | OXN PR Tablet | Oxycodone Naloxone Prolonged Release (OXN PR) tablets |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Short Form McGill Pain Score. | 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. | Posted | Mean | Standard Deviation | units on a scale | Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal) |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Tablets | A placebo tablet to match the active reference treatment | 0 | 50 | 22 | 50 | ||
| EG001 | OXN PR Tablet | Oxycodone Naloxone Prolonged Release (OXN PR) tablets | 4 | 48 | 36 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Disease | Cardiac disorders | MedDRA | Non-systematic Assessment | This subject also had an SAE (Serious Adverse Event) of Iliac Artery Stenosis. Unrelated to study drug. |
|
| Iliac Artery Stenosis | Vascular disorders | MedDRA | Non-systematic Assessment | This patient also had an SAE (Serious Adverse Event) of Coronary Artery Disease. Unrelated to study drug. |
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| Cystitis | Infections and infestations | MedDRA | Non-systematic Assessment | Unrelated to study drug. |
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| Wound Abscess | Infections and infestations | MedDRA | Non-systematic Assessment | Unrelated to study drug. |
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| Atrial Fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment | "Unlikely" relationship to study drug |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Disorders | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Ear and Labyrinth disorder | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
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| Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| General Disorders and Administration Site Conditions | General disorders | MedDRA | Non-systematic Assessment |
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| Hepatobiliary Disorders | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
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| Infections and Infestations | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Injury, Poisoning and Procedural Complications | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Investigations | Investigations | MedDRA | Non-systematic Assessment |
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| Metabolism and Nutrition Disorders | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Nervous System disorders | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Psychiatric Disorders | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Renal and Urinary Disorders | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
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| Respiratory, Thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Vascular Disorders | Vascular disorders | MedDRA | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Medical Operations | Mundipharma Research GmbH | 44 01223424900 | info@contact-clinical-trials.com |
| ID | Term |
|---|---|
| C557247 | oxycodone naloxone combination |
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| >=65 years |
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| Male |
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| Germany |
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| Hungary |
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| Romania |
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