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Phase 2 Dose-Ranging Study of SKY0402 for Prolonged Postoperative Analgesia in Subject Undergoing Hemorrhoidectomy

NCT00529126 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-03-04

Study results available
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Summary

Phase 2 study to evaluate three dose levels of SKY0402 compared with 75 mg of bupivacaine HCl.

Conditions

  • Postoperative Pain

Interventions

DRUG

SKY0402

SKY0402

DRUG

Bupivacaine HCl

Bupivacaine HCl

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Erol Onel, MD · Pacira Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2007-12-31
Completion
2008-07-31

Countries

  • United States
  • Georgia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00529126 on ClinicalTrials.gov