Current partner codePEPTIDESDE
NCT00981682·Phase 3·INTERVENTIONAL

Long Term Safety Assessment of SER120 in Patients With Nocturia

Status

Completed

Phase

Phase 3

Enrollment

376

Locations

1

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

DRUG

SER120

once a day treatment of nocturia

Timeline

From registration to results.

  1. First posted

    Sep 22, 2009

  2. Study start

    Aug 2009

  3. Primary completion

    Jun 2011

  4. Study completion

    Aug 2011

  5. Results posted

    Jan 20, 2021

  6. Registry updated

    Jan 20, 2021

Outcomes

What the study measures.

Primary outcomes

Mean Serum Sodium

Time frame · 40 weeks

Change in mean serum sodium on Day 8, Day 15, Day 22, Week 4, Week 8, Week 12, Week 20, Week 28 and Week 40 compared to Baseline

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
50 Years
Maximum age
90 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Stephen M. Auerbach, MD

Newport Beach, California, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Desmopressin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.