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

AstraZeneca AB0 sites135 target enrollmentJuly 16, 2010

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: AstraZeneca AB
Enrollment: 135
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 16, 2010

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

AstraZeneca AB

Eligibility Criteria

Inclusion Criteria

•1\. Provision of informed consent prior to any study specific procedures
•2\. Male, or non\-pregnant and non\-lactating female (18\-80 years, inclusive). Women considered to be of non\-child bearing potential included in the study must be permanently or surgically sterilised or post menopausal:
•\-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.
•Women of childbearing potential included in the study must use a contraceptive method capable of achieving a failure rate of less than 1 percent per year when used consistently and correctly such as: cupper IUD, intrauterine levonorgestrel system, medroxyprogesterone depot injections, etonogestrel implants or normal and low dose combination pills. Not acceptable methods includes, but is not restricted to: barrier methods, progesterone pills, non\-cupper IUD and coitus interruptus.
•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.

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.