Completed PHASE2 INTERVENTIONAL 7-arm NCT01084161

Study to Evaluate the Efficacy, Safety and Tolerability of N1539

A Randomized Double-Blind, Placebo- and Active-Controlled, Dose-Ranging Study to Evaluate the Analgesic, Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Open Abdominal Hysterectomy

Sponsor: Alkermes, Inc.

Conditions Hysterectomy

Interventions Morphine N1539 placebo

Updated 8 times since 2017 Last updated: Nov 28, 2011 Started: Mar 31, 2010 Primary completion: Jan 31, 2011 Completion: Jan 31, 2011

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Hysterectomy and is currently completed. Alkermes, Inc. leads this study, which shows 8 recorded versions since 2010 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

8 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Apr 2022 — Jul 2024 [monthly]

Completed PHASE2
Jan 2021 — Apr 2022 [monthly]

Completed PHASE2

▶ Show 3 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE2
Feb 2017 — Jun 2018 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Mar 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Alkermes, Inc.

Data source: Alkermes, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Belgrade, Serbia , Bialystok, Poland , Gdansk, Poland , Kragujevac, Serbia , Lodz, Poland , Lublin, Poland , Novi Sad, Serbia , Poznan, Poland , Ruda Śląska, Poland , Szczecin, Poland and 1 more location