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Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00723827
First Posted: July 29, 2008
Last Update Posted: January 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose

The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of Temodal capsule (temozolomide) under actual conditions of use, and to understand some of the following points that are in question and doubt:

  • Incidence of adverse events under actual conditions of use (Serious and Nonserious Adverse Events);
  • Adverse Drug Reactions not shown in the directions for use (will be stated as Unexpected Adverse Reaction);
  • Adverse Event caused by misuse, abuse, or drug interactions;
  • Other information concerned with safety or efficacy.

Condition Intervention
Glioblastoma Glioma Astrocytoma Drug: Temozolomide Radiation: Radiotherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Temodal (Temozolomide) Post Marketing Surveillance Protocol

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Complete study duration & 30 days after completion (up to approximately 7.5 months) ]
    An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of vaccine, whether or not considered related to the medicinal product.

  • Number of Participants Experiencing Unexpected Adverse Drug Reactions (ADRs) [ Time Frame: Complete study duration & 30 days after completion (up to approximately 7.5 months) ]
    An unexpected ADR was defined as an adverse reaction, whose nature, severity, specificity, or outcome is not consistent with the term or description used in the applicable product information.

  • Number of Temozolomide Misuse or Abuse Events [ Time Frame: Complete study duration & 30 days after completion (up to approximately 7.5 months) ]

    Drug abuse was defined as the use of the study drug for a non-therapeutic effect.

    Misuse was defined as use of the study medication in a way that was not prescribed.


  • Number of Temozolomide Drug Interactions [ Time Frame: Complete study duration & 30 days after completion (up to approximately 7.5 months) ]
    Drug interaction was defined as a chemical or physiological reaction that can occur when two different drugs are taken together.

  • Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD) [ Time Frame: Complete study duration (up to approximately 6.5 months) ]
    The response ratings were based on the judgment of the investigator.


Enrollment: 682
Study Start Date: March 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All Participants
Participants with newly diagnosed glioblastoma multiforme (treat with temozolomide & radiotherapy) or participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy (treat with temozolomide).
Drug: Temozolomide
Administration of temozolomide based on the product labeling.
Other Names:
  • Temodal
  • Temodar
  • SCH 052365
  • MK-7365
Radiation: Radiotherapy
Radiotherapy given concomitantly with temozolomide for newly diagnosed glioblastoma multiforme.
Other Names:
  • Radiation therapy
  • irradiation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Participants with newly diagnosed glioblastoma multiforme.

Participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Criteria

Inclusion Criteria:

  • Participants who are prescribed with temozolomide by local labeling:

    • participants with newly diagnosed glioblastoma multiforme;
    • participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Exclusion Criteria:

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00723827     History of Changes
Other Study ID Numbers: P05557
First Submitted: July 25, 2008
First Posted: July 29, 2008
Results First Submitted: December 5, 2012
Results First Posted: January 8, 2013
Last Update Posted: January 30, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents