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EN3285 for the Prevention or Delay of Oral Mucositis in Patients With Head and Neck Cancer

This study has been terminated.
(Additional research)
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00574860
First received: December 14, 2007
Last updated: September 17, 2013
Last verified: September 2013

December 14, 2007
September 17, 2013
December 2007
June 2009   (final data collection date for primary outcome measure)
NCI v3 to measure severity of OM [ Time Frame: At 50 Gy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00574860 on ClinicalTrials.gov Archive Site
WHO criteria for measuring severity of OM [ Time Frame: At 50 Gy ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
EN3285 for the Prevention or Delay of Oral Mucositis in Patients With Head and Neck Cancer
A Phase 3, Multi-center, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Efficacy and Safety of EN3285 for the Prevention or Delay to Onset of Severe Oral Mucositis in Patients With Head and Neck Cancer Receiving Chemoradiotherapy

Randomized, double-blind, placebo-controlled study for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM).

This randomized, double-blind, placebo-controlled study will be conducted in patients receiving chemoradiotherapy (ChemoRT) for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM). The study includes a treatment period of up to 8 weeks, based on the patients' prescribed treatment plan, with a follow-up period of 12 months following completion of radiotherapy (RT).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Oral Mucositis
  • Head and Neck Cancer
  • Drug: EN3285
    Oral rinse
  • Drug: Placebo
    Oral rinse
  • Other: Standard of care
    This will be the therapy most commonly used the the institution treating the patient
  • Experimental: EN3285 (NAC ProGelz)
    The EN3285 arm is the product under development
    Intervention: Drug: EN3285
  • Placebo Comparator: No active ingredients (placebo)
    This will be an oral product that contains no active ingredient
    Intervention: Drug: Placebo
  • Standard of Care
    This arm will reflect the typical standard of care for the patient
    Intervention: Other: Standard of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
240
June 2009
June 2009   (final data collection date for primary outcome measure)

Significant Inclusion Criteria:

  • 18 years and older
  • newly diagnosed SCC of the oral cavity and/or oropharynx, and are intended for treatment with ChemoRT.
  • Have a clinical plan to receive a minimum of 60 Gy to the oral cavity and/or oropharynx
  • Chemotherapy: cisplatin
  • Have a WBC ≥3500 per cubic millimeter
  • Have a platelet count ≥100,000 per cubic millimeter
  • Have adequate renal function as determined by the principal investigator prior to enrollment
  • Are willing and able to undergo oral assessments
  • Have a Karnofsky Performance Status score ≥70

Significant Exclusion Criteria:

  • Have OM or other oral conditions at study entry
  • Plan to use Amifostine, Pilocarpine, Cevimeline or Bethanechol
  • Are using a pre-existing feeding tube for nutritional support at study entry
  • Plan to use any drug for the treatment or prevention of OM
  • Have had any prior radiotherapy to the head and neck
  • Have had prior chemotherapy within 6 months preceding enrollment
  • Plan to have concurrent chemotherapy, other than those regimens specified under inclusioncriteria
  • Have received other investigational drugs in the 30 days preceding initiation of study drug or during administration of study drug
  • Have medical conditions that require the use of chronic steroid therapy
  • Have the inability to undergo repeat treatments,
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00574860
EN3285-301
Yes
Endo Pharmaceuticals
Endo Pharmaceuticals
Not Provided
Principal Investigator: Mark Chambers, MD M.D. Anderson Cancer Center
Endo Pharmaceuticals
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP