Long Term Safety Assessment of SER120 in Patients With Nocturia

Serenity Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Nocturia

Treatments: Drug: SER120

Study type: Interventional

Funder types: Industry

Identifiers

NCT00981682

SPC-SER120-OL1-200903

Details and patient eligibility

About

The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic patients.

Enrollment: 376 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients completed SPC-SER120-DB1-200901 and SPC-SER120-DB2-200902 studies
• Willing to provide consent for the study

Exclusion criteria

• Incontinence
• Diabetes Insipidus, Diabetes Mellitus
• CHF
• Renal Insufficiency
• Significant medical history which make participation unacceptable

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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376 participants in 1 patient group

SER120 (desmopressin)

Experimental group

Treatment:

Drug: SER120