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A Randomized Withdrawal Active- and Placebo-Controlled Double-Blind Multi-Center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 PR in Subjects With Moderate to Severe Chronic Malignant Tumor-Related Pain. PR Means Prolonged Release and is the Recommended Nomenclature for Use in EU. ER Means Extended Release and is the Recommended Nomenclature for Use in USA. 'PR' is Synonymous With 'ER' and is Interchangeable in the Protocol.

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Trial Profile

A Randomized Withdrawal Active- and Placebo-Controlled Double-Blind Multi-Center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 PR in Subjects With Moderate to Severe Chronic Malignant Tumor-Related Pain. PR Means Prolonged Release and is the Recommended Nomenclature for Use in EU. ER Means Extended Release and is the Recommended Nomenclature for Use in USA. 'PR' is Synonymous With 'ER' and is Interchangeable in the Protocol.

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 01 Apr 2022

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At a glance

  • Drugs Tapentadol (Primary) ; Morphine
  • Indications Cancer pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Grunenthal

    • Most Recent Events

    • 17 Jul 2009 Planned end date changed from 1 Apr 2009 to 1 Aug 2009 as reported by ClinicalTrials.gov.
    • 17 Jul 2009 Status changed from recruiting to discontinued as reported by ClinicalTrials.gov.
    • 08 Mar 2008 New trial locations added.
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