Moderate to Severe Pain Due to Diabetic Polyneuropathy
Conditions
Brief summary
To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone.
Detailed description
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.
Interventions
Oxycodone Naloxone tablets
DRUGPlacebo tablets
Placebo Oxycodone Naloxone tablets
Sponsors
Mundipharma Research GmbH & Co KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate to severe pain due diabetic polyneuropathy * Opioid-naive subjects
Exclusion criteria
* Females who are pregnant or lactating * Subjects with evidence of significant structural abnormalities of the gastrointestinal tract * Subjects with evidence of impaired liver/kidney function upon entry into the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Form McGill Pain Score. | Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal) | 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. |
Countries
Germany
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Tablets A placebo tablet to match the active reference treatment | 50 |
| OXN PR Tablet Oxycodone Naloxone Prolonged Release (OXN PR) tablets | 48 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative | 1 | 1 |
| Overall Study | Adverse Event | 0 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo Tablets | OXN PR Tablet | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 13 Participants | 31 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 35 Participants | 67 Participants |
| Age Continuous | 62.24 years STANDARD_DEVIATION 9.39 | 58.96 years STANDARD_DEVIATION 10.03 | 60.63 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment Czech Republic | 21 participants | 19 participants | 40 participants |
| Region of Enrollment Germany | 7 participants | 7 participants | 14 participants |
| Region of Enrollment Hungary | 11 participants | 11 participants | 22 participants |
| Region of Enrollment Romania | 11 participants | 11 participants | 22 participants |
| Sex: Female, Male Female | 23 Participants | 25 Participants | 48 Participants |
| Sex: Female, Male Male | 27 Participants | 23 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 50 | 36 / 48 |
| serious Total, serious adverse events | 0 / 50 | 4 / 48 |
Outcome results
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.
Time frame: Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Tablets | Short Form McGill Pain Score. | 49.56 units on a scale | Standard Deviation 29.62 |
| OXN PR Tablet | Short Form McGill Pain Score. | 47.65 units on a scale | Standard Deviation 30.27 |