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NCT00609466 · ClinicalTrials.gov registry record · Phase 3

A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy

A Phase 3 study, sponsored by Grünenthal.

Completed
Registry status
Phase 3
Development phase
291
Enrollment target

NCT00609466 is a Phase 3 study that has completed, run by Grünenthal. The registered enrollment target is 291 participants.

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The verdict

NCT00609466, a Phase 3 study, has completed, sponsored by Grünenthal.

COMPLETED
Registry status
Phase 3
Development phase
291 participants
Enrollment target

Study Summary

The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose application of oral application of CG5503 IR 75mg compared to placebo and to assess safety and tolerability of CG5503 IR 75mg in subjects following bunionectomy. This trial was performed based on a previously performed double-blind, placebo-controlled, multiple-dose trial in the same indication investigating 3 dose strengths CG5503 IR (50, 75 and 100 mg) published under PMID: 18851776.

Interventions

  • DRUG Placebo
  • DRUG Morphine
  • DRUG CG5503 IR

Trial Details

FieldValue
Enrollment Target 291 participants
Start Date 2007-09
Est. Completion 2008-02
Phase Phase 3

Sponsor

Grünenthal

16 total trials

What the Registry Record Tells You About NCT00609466

The ClinicalTrials.gov registry entry for NCT00609466 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 291 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grünenthal, which has 16 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00609466 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00609466 about?

NCT00609466 is a clinical study titled "A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy". The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose application of oral application of CG5503 IR 75mg compared to placebo and to assess safety and tolerability of CG5503 IR 75mg in subjects following bunionectomy. This trial was performed based on a previousl...

What is the current status of trial NCT00609466?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 291 participants. The study started on 2007-09. Estimated completion is 2008-02.

What interventions are being tested in trial NCT00609466?

The interventions under investigation include: Placebo (DRUG), Morphine (DRUG), CG5503 IR (DRUG).

Who is sponsoring clinical trial NCT00609466?

This trial is sponsored by Grünenthal, which has 16 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.