A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Neuropathic Pain

Treatments: Drug: Placebo; Drug: AZD2423

Study type: Interventional

Funder types: Industry

Identifiers

NCT01201317

D2600C00005

Details and patient eligibility

About

A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with painful diabetic polyneuropathy.

Enrollment: 134 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of signed informed consent form
• Males and female of non-child bearing potential patients aged 18 to 80 years
• Patients with neuropathic pain due to painful diabetic polyneuropathy.

Exclusion criteria

• Other pain that may confound assessment of neuropathic pain
• History of treatment failure with more than three adequate trials of medication for neuropathic pain
• Central neuropathic pain conditions (caused by Central Nervous System injury/disease, eg. Stroke)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

134 participants in 3 patient groups, including a placebo group

AZD2423, 150 mg

Experimental group

Description:

Tablets, 150 mg once daily in the morning.

Treatment:

Drug: AZD2423

Drug: AZD2423

AZD2423, 20 mg

Experimental group

Description:

Tablets, 20 mg once daily in the morning.

Treatment:

Drug: AZD2423

Drug: AZD2423

Placebo

Placebo Comparator group

Description:

Tablets, placebo, once daily in the morning.

Treatment:

Drug: Placebo