Terminated PHASE3 INTERVENTIONAL 2-arm NCT00813111

Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation

A Phase 3, Multicenter, Randomized, Double-blind Parallel-group, Active-control Study to Evaluate the Safety and Efficacy of Local Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Bilateral, Cosmetic Sub-muscular Breast Augmentation

Sponsor: Pacira Pharmaceuticals, Inc

Conditions Pain

Interventions Bupivacaine HCl SKY0402

Updated 8 times since 2017 Last updated: Nov 30, 2013 Started: Nov 30, 2008 Primary completion: Feb 28, 2009 Completion: Feb 28, 2009

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

Terminated

Sponsor decision, unrelated to safety

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This PHASE3 trial investigates Pain and is currently terminated or withdrawn. Pacira Pharmaceuticals, Inc leads this study, which shows 8 recorded versions since 2008 — 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 2024 — Present [monthly]

Terminated PHASE3
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE3
Jan 2023 — Jul 2024 [monthly]

Terminated PHASE3
Dec 2022 — Jan 2023 [monthly]

Terminated PHASE3
Jan 2021 — Dec 2022 [monthly]

Terminated PHASE3

▶ Show 3 earlier versions

Jun 2018 — Jan 2021 [monthly]

Terminated PHASE3
Feb 2017 — Jun 2018 [monthly]

Terminated PHASE3
Jan 2017 — Feb 2017 [monthly]

Terminated PHASE3

First recorded

Nov 2008

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Pacira Pharmaceuticals, Inc

Data source: Pacira Pharmaceuticals, Inc

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

Study Locations

Bellaire, United States , Birmingham, United States , Boston, United States , Columbus, United States , La Jolla, United States , Lexington, United States , Miami, United States , Mobile, United States , Pasadena, United States , Roswell, United States and 3 more locations