A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients

Astellas

Status and phase: Completed; Phase 3

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Drug: placebo; Drug: zolpidem MR; Drug: nitrazepam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00374777

6199-CL-0008

Details and patient eligibility

About

A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo and nitrazepam as a comparative drug.

Enrollment: 450 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Nonorganic insomnia associated with schizophrenia and manic-depressive psychosis.

Exclusion criteria

• Patients with allergic reactions to zolpidem or nitrazepam; Patients with serious cardiac disorders; serious hepatic impairment; serious renal diseases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

450 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: zolpidem MR

2

Experimental group

Treatment:

Drug: zolpidem MR

3

Active Comparator group

Treatment:

Drug: nitrazepam

4

Placebo Comparator group

Treatment:

Drug: placebo