Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Diabetic Neuropathy; Pain

Treatments: Drug: Placebo; Drug: AZD2066

Study type: Interventional

Funder types: Industry

Identifiers

NCT00857623

D0475C00009

Details and patient eligibility

About

The purpose of this study is to investigate if AZD2066 can relieve the pain arising from painful diabetic neuropathy compared to placebo.

Enrollment: 127 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of informed consent prior to any study specific procedures.
• Clinical diagnosis of painful diabetic neuropathy.
• non-fertile females

Exclusion criteria

• Other pain that may confound assessment of neuropathic pain.
• Ongoing significant peripheral arterial diseases, skin ulcers, or amputation in the lower extremities.
• History of psychotic disorders among first degree relatives.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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127 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD2066

2

Placebo Comparator group

Treatment:

Drug: Placebo