A Phase IIa, Double-blind, Randomised, Parallel-group, Multi-centre Study to Evaluate the Analgesic Efficacy of 28 Days Oral Administration of AZD2423 Compared to Placebo in Patients with Posttraumatic Neuralgia

Phase 1

• Conditions: Posttraumatic Neuralgia (neuropathic pain); MedDRA version: 12.1Level: LLTClassification code 10054095Term: Neuropathic pain

• Registration Number: EUCTR2010-019785-90-FR
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-09
• Study Completion: 2012-04-01
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

1. Provision of informed consent prior to any study specific procedures
2. Male, or female of non-child bearing potential (18-80 years, inclusive). Only
women of non-child bearing potential are included in the study, ie, women who are
permanently or surgically sterilised or post menopasual:
- Women will be considered post menopausal if they are amenorrheic for 12
months without an alternative medical cause.
The following age-specific requirements apply:
- Women under 50 years old will be considered post menopausal if they have
been amenorrhoeic for 12 months or more following cessation of exogenous
hormonal treatments and with LH and FSH levels in the post-menopausal
range.
- Women over 50 years of age will be considered postmenopausal if they have
been amenorrheic for 12 months or more following cessation of all exogenous
hormonal treatments.
Permanent sterilization includes hysterectomy and/or bilateral oopherectomy and/or
bilateral salpingectomy but excludes bilateral tubal occlusion.
3. Neuropathic pain due to peripheral nerve injury caused by trauma or surgery.
Duration of neuropathic pain must be at least three months and at most 5 years.
Complex Regional Pain Syndrome (CRPS) type II is accepted provided that pain is
due to a defined nerve injury. Nerve injuries at plexus or root level are excluded.
4. Pain intensity (7 days recall) of 4-9 (inclusive) on NRS - Average Pain (0-10) is
required for enrolment. At randomisation a 5-day mean baseline NRS - Average
Pain intensity (12 h recall twice daily, morning and evening) of 4-9 (inclusive) is
required. The patient is also required to complete at least 4 out of 5 morning and
evening baseline NRS - Average Pain assessments Day –5 to Day –1 to be eligible.
5. Be able to understand and comply with the requirements of the study as judged by the investigator.
For inclusion in the genetic research, patients must fulfil the following criterion:
6. Provision of informed consent for genetic research
If a patient declines to participate in the genetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this CSP, so long as they consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Involvement in the planning and/or conduct of the study (applies to both
AstraZeneca staff and/or staff at the study site).
2. Previous enrolment or randomisation in the present study.
3. Participation in another clinical study with an IP during the last 30 days prior to
enrolment.
4. Other pain that may confound assessment of neuropathic pain, as judged by the
investigator.
5. Central neuropathic pain conditions (caused by CNS injury/disease, eg, stroke,
multiple sclerosis or spinal cord injury).
6. Any prior treatment of neuropathic pain with intrathecal pump or spinal cord
stimulator.
7. History of treatment failure with =3 adequate trials of medications used to treat
neuropathic pain, as judged by the investigator.
8. Use of any prohibited medication (see Table 4) at Visit 2.
9. History of any unstable medical disease (eg,, cardiovascular, renal insufficiency,
hepatic insufficiency) which may interfere with the objectives of the study or with
the safety of the subject, as judged by the investigator.
10. History of gastric ulcer or haemorrhage
11. History of significant psychiatric disease/disorder that could preclude reliable
participation in the study, as judged by the investigator.
29(77)
- Patients with a diagnosis of depression who are in remission for at least 12 weeks before enrolment with or without stable SSRI treatment are allowed
in the study.
12. Patient with a cognitive disorder which could impair cooperation with study
procedures, as judged by the investigator.
13. Clinically significant illness within 2 weeks before the administration of the IP as
judged by the investigator.
14. Known malignancy within the past 5 years (with the exception of successfully
treated basal cell carcinoma).
15. Malabsorption, gastrointestinal disorder or surgery leading to impaired drug
absorption.
16. Donation of plasma from 2 weeks before Visit 1 (enrolment visit) or donation of
blood from 3 months before Visit 1.
17. Abnormal vital signs, laboratory test value or ECG of clinical significance, as
judged by the investigator.
- QTcF>450 ms or <340 ms, or a family history of long QT syndrome.
- Calculated Creatinine clearance =50 mL/min assessed by the Cockroft-Gault
method.
- ALT or AST >1.5xULN
- Bilirubin > 1xULN
18. Positive Tuberculosis screening (i.e. chest x-ray and QuantiFERON® – TB Gold
according to local requirements) as judged by investigator.
19. Immunisation with live vaccine within the previous 3 months, for other vaccines
within the past 30 days.
20. History of latent, chronic, or recurrent infections (eg, tuberculosis, recurrent
sinusitis, genital herpes, urinary tract infections) or at risk of infection (surgery,
trauma or significant infection, history of skin abscesses within 90 days prior to
Visit 1).
21. Women with a positive pregnancy test on enrolment or before randomisation or
lactating women.
22. History of alcohol or drug abuse within 2 years of entering the study.
23. Contraindication to ibuprofen/NSAIDs, such as ulcer and history of hypersensitivity
reactions (eg, asthma, rhinitis or urticaria).
24. History of or positive test of human immunodeficiency virus (HIV) or hepatitis B or
C.
25. Positive urine toxicology results for drugs of abuse including cannabis, cocaine,
ecstacy, heroin/morphine, amphetamine and phenocyclidine (PCP). Visit 1 urine
toxicology results indicating opiate or other prescribed analgesic (including
benzodiazepines) use in patients who had been receiving the medications for
therapeutic re

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days of oral administration in patients with PTN.;Secondary Objective: 1. To investigate the responder rate of patients receiving AZD2423 compared to<br>placebo in patients with PTN.<br>2. To investigate the analgesic efficacy of AZD2423 on different components of pain<br>compared to placebo in patients with PTN.<br>3. To investigate the effect of AZD2423 on different functional consequences of pain<br>compared to placebo in patients with PTN.<br>4. To investigate the PK of AZD2423 in patients with PTN.<br>5. To investigate the safety and tolerability of AZD2423 in patients with PTN.;Primary end point(s): Change from baseline in mean NRS Average Pain Score