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NCT01357356 · ClinicalTrials.gov registry record · Phase 2

Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia

A Phase 2 study, sponsored by Serenity Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
750
Enrollment target

NCT01357356: Completed Phase 2 study, sponsored by Serenity Pharmaceuticals.

NCT01357356 is a Phase 2 study that has completed, run by Serenity Pharmaceuticals. The registered enrollment target is 750 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (464% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01357356, a Phase 2 study, has completed, sponsored by Serenity Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
750 participants
Enrollment target

Study Summary

The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia for a total duration of 14 weeks.

Primary Outcome

Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12

Interventions

  • DRUG Placebo
  • DRUG SER120 (750 ng/day)
  • DRUG SER120 (1000 ng/day)
  • DRUG SER120 (1500 ng/day)

Trial Details

FieldValue
Enrollment Target 750 participants
Start Date 2011-05
Est. Completion 2014-12
Phase Phase 2
Serenity Pharmaceuticals

6 total trials

What the finished NCT01357356 record still lists

NCT01357356 is an interventional study that assigns participants to a tested intervention. The registered 750 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (464% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT01357356 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01357356 about?

NCT01357356 is a clinical study titled "Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia". The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia for a total duration of 14 weeks.

What is the current status of trial NCT01357356?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 750 participants. The study started on 2011-05. Estimated completion is 2014-12.

What interventions are being tested in trial NCT01357356?

The interventions under investigation include: Placebo (DRUG), SER120 (750 ng/day) (DRUG), SER120 (1000 ng/day) (DRUG), SER120 (1500 ng/day) (DRUG).

Who is sponsoring clinical trial NCT01357356?

This trial is sponsored by Serenity Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01357356's enrollment target sits among peer trials

750 43rd of 2000 higher than 1,957 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01357356, the US trial registry maintained by the National Library of Medicine. NCT01357356 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.