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A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy

NCT00478023 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 854

Last updated 2019-10-28

Study results available
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Summary

The main objective of this study is to demonstrate the efficacy and safety of multiple-dose application of three different oral doses of CG5503 IR (tapentadol immediate release) compared to placebo in women undergoing abdominal hysterectomy.

Conditions

  • Hysterectomy
  • Postoperative

Interventions

DRUG

Morphine

20 mg IR; 4 - 6 hourly; Total 72 hours

DRUG

CG5503 IR

50mg; 4 - 6 hourly; Total 72 hours

DRUG

CG5503 IR

75mg; 4 -6 hourly; Total 72 hours

DRUG

CG5503 IR

100mg, 4 - 6 hourly; Total 72 hours

DRUG

Placebo

4 - 6 hourly; Total 72 hours

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    collaborator INDUSTRY

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Tomasz Rechberger, Prof. · Samodzielny Publiczny Szpital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-02-29
Completion
2008-04-30

Countries

  • Hungary
  • Latvia
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • Slovenia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

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 NCT00478023 on ClinicalTrials.gov