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NCT01259128 · ClinicalTrials.gov registry record · Phase 3

Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia

A Phase 3 study, sponsored by Serenity Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
32
Enrollment target

NCT01259128: Completed Phase 3 study, sponsored by Serenity Pharmaceuticals.

NCT01259128 is a Phase 3 study that has completed, run by Serenity Pharmaceuticals. The registered enrollment target is 32 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01259128, a Phase 3 study, has completed, sponsored by Serenity Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
32 participants
Enrollment target

Study Summary

The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.

Primary Outcome

Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57.

Interventions

  • DRUG SER120 Nasal Spray 500 ng/day
  • DRUG SER120 nasal spray 750 ng/day

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2010-04
Est. Completion 2010-11
Phase Phase 3
Serenity Pharmaceuticals

6 total trials

What the finished NCT01259128 record still lists

NCT01259128 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which SER120 Nasal Spray 500 ng/day is the first listed.

NCT01259128 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01259128 about?

NCT01259128 is a clinical study titled "Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia". The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.

What is the current status of trial NCT01259128?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 32 participants. The study started on 2010-04. Estimated completion is 2010-11.

What interventions are being tested in trial NCT01259128?

The interventions under investigation include: SER120 Nasal Spray 500 ng/day (DRUG), SER120 nasal spray 750 ng/day (DRUG).

Who is sponsoring clinical trial NCT01259128?

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 NCT01259128's enrollment target sits among peer trials

32 1909th of 2000 higher than 87 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01259128, the US trial registry maintained by the National Library of Medicine. NCT01259128 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.