Nerve Pain
Conditions
Keywords
Analgesic effect
Brief summary
A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with posttraumatic neuralgia.
Interventions
DRUGAZD2423
20 mg tablet
DRUGPlacebo
Placebo
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Provision of signed informed consent form * Males and female patients aged 18 to 80 years * Patients with neuropathic pain due to peripheral nerve injury caused by trauma or surgery
Exclusion criteria
* Other paint that may confound assessment of neuropathic pain * History of treatment failure with more than three adequate trials of treatment for neuropathic pain * Central neuropathic pain conditions (caused by Central Nervous System injury/disease, eg. Stroke)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score. | Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28 | Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) scale 0-10. 0= No pain, 10= Worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score | Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28 | Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Worst Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable. |
| Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | Baseline (mean of Day -5 to Day -1) to Day 28 | LOCF- Last Observation Carried Forward. Numerical Rating Scale (NRS) Average Pain score reduction= (change from baseline at Day 28/baseline)\*100. Responder=NRS Average Pain score reduction ≥30% (yes/no) |
| Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28. | Baseline (mean of Day -5 to Day -1) to Day 28 | Last Observation Carried Forward (LOCF). Numerical Rating Scale (NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)\*100. Responder= NRS Average Pain score reduction ≥50% (yes/no) |
| Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score. | Baseline (Day 1) to Day 29 (Visit 7) | LOCF- Last Observation Carried Forward. At baseline and at end of treatment the participants filled in their Neuropathic Pain Symptom Inventory Scal (NPSI) pain symptom descriptors, recall period 24 hours. Each descriptor was rated on a NUmerical Rating Scale 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Higher total score is considered worse outcome. |
Countries
Bulgaria, Denmark, France, Poland, Russia, Sweden, United Kingdom
Participant flow
Recruitment details
The first participant was enrolled on 6th October 2010 and the last participant completed on 3rd April 2012. A total of 36 centres in France, Denmark, Poland, Russia, UK, Sweden and Bulgaria randomised 133 participants.
Pre-assignment details
The study had an enrolment phase of up to 30 days (including wash-out period), a 28-day treatment phase, and a follow-up phase of 7-14 days. Participants were randomly assigned to blinded treatment in a 1:1:1 ratio either to AZD2423 20 mg, AZD2423 150 mg or placebo.
Participants by arm
| Arm | Count |
|---|---|
| AZD2423, 150 mg AZD2423 : 3x50 mg tablet once daily in the morning | 41 |
| AZD2423, 20mg AZD2423 : 1x20 mg tablet once daily in the morning | 48 |
| Placebo Tablet to match the 20 mg and 50 mg AZD2423 active tablet
Placebo : Placebo | 44 |
| Total | 133 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Non availability of study nurse | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 3 |
Baseline characteristics
| Characteristic | AZD2423, 150 mg | AZD2423, 20mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 50.9 Years STANDARD_DEVIATION 10.9 | 53.1 Years STANDARD_DEVIATION 10.9 | 55.1 Years STANDARD_DEVIATION 10.9 | 53.1 Years STANDARD_DEVIATION 10.9 |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 41 Participants | 47 Participants | 44 Participants | 132 Participants |
| Sex: Female, Male Female | 17 Participants | 26 Participants | 19 Participants | 62 Participants |
| Sex: Female, Male Male | 24 Participants | 22 Participants | 25 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 41 | 14 / 48 | 10 / 44 |
| serious Total, serious adverse events | 0 / 41 | 0 / 48 | 0 / 44 |
Outcome results
Primary
Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.
Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) scale 0-10. 0= No pain, 10= Worst pain imaginable.
Time frame: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28
Population: mITT analysis set including only those that had adequate NRS data at baseline and Days 24-28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD2423, 150 mg | Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score. | -1.53 Scores on a scale | Standard Deviation 1.67 |
| AZD2423, 20mg | Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score. | -1.54 Scores on a scale | Standard Deviation 1.5 |
| Placebo | Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score. | -1.44 Scores on a scale | Standard Deviation 1.59 |
Secondary
Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score.
LOCF- Last Observation Carried Forward. At baseline and at end of treatment the participants filled in their Neuropathic Pain Symptom Inventory Scal (NPSI) pain symptom descriptors, recall period 24 hours. Each descriptor was rated on a NUmerical Rating Scale 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Higher total score is considered worse outcome.
Time frame: Baseline (Day 1) to Day 29 (Visit 7)
Population: mITT analysis set including only those that had adequate NPSI data at baseline and Day 29
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD2423, 150 mg | Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score. | -16.58 Scores on a scale | Standard Deviation 22.4 |
| AZD2423, 20mg | Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score. | -8.82 Scores on a scale | Standard Deviation 18.11 |
| Placebo | Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score. | -9.8 Scores on a scale | Standard Deviation 15.44 |
Secondary
Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score
Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Worst Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable.
Time frame: Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28
Population: mITT analysis set including only those that had adequate NRS data at baseline and Days 24-28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD2423, 150 mg | Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score | -1.8 Scores on a scale | Standard Deviation 2.09 |
| AZD2423, 20mg | Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score | -1.29 Scores on a scale | Standard Deviation 1.5 |
| Placebo | Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score | -1.4 Scores on a scale | Standard Deviation 1.66 |
Secondary
Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.
LOCF- Last Observation Carried Forward. Numerical Rating Scale (NRS) Average Pain score reduction= (change from baseline at Day 28/baseline)\*100. Responder=NRS Average Pain score reduction ≥30% (yes/no)
Time frame: Baseline (mean of Day -5 to Day -1) to Day 28
Population: mITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AZD2423, 150 mg | Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | 17 Participants |
| AZD2423, 20mg | Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | 15 Participants |
| Placebo | Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28. | 17 Participants |
Secondary
Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28.
Last Observation Carried Forward (LOCF). Numerical Rating Scale (NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)\*100. Responder= NRS Average Pain score reduction ≥50% (yes/no)
Time frame: Baseline (mean of Day -5 to Day -1) to Day 28
Population: mITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AZD2423, 150 mg | Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28. | 9 Participants |
| AZD2423, 20mg | Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28. | 8 Participants |
| Placebo | Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28. | 9 Participants |