Safety and Efficacy of RK0202 in Oral Mucositis
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ClinicalTrials.gov Identifier: NCT00230191 |
Recruitment Status
:
Completed
First Posted
: September 30, 2005
Last Update Posted
: January 15, 2007
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Sponsor:
RxKinetix
Information provided by:
RxKinetix
Tracking Information | |||||||||||||||||||||||||||||||
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First Submitted Date ICMJE | September 28, 2005 | ||||||||||||||||||||||||||||||
First Posted Date ICMJE | September 30, 2005 | ||||||||||||||||||||||||||||||
Last Update Posted Date | January 15, 2007 | ||||||||||||||||||||||||||||||
Study Start Date ICMJE | January 2003 | ||||||||||||||||||||||||||||||
Primary Completion Date | Not Provided | ||||||||||||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
The primary objective of the study is to assess the effect of RK-0202 versus placebo on the incidence and severity of oral mucositis. | ||||||||||||||||||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||
Change History | Complete list of historical versions of study NCT00230191 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
The secondary objectives of the study are to assess the safety and tolerability of RK-0202 in these subjects and to explore whether the ProGelz™ vehicle alone is active in these subjects. | ||||||||||||||||||||||||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||||||||||||
Brief Title ICMJE | Safety and Efficacy of RK0202 in Oral Mucositis | ||||||||||||||||||||||||||||||
Official Title ICMJE | Phase II, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of the Effects of RK-0202 on Oral Mucositis in Patients Receiving Radiation Therapy for Tumors of the Oral Cavity, Oropharynx, Nasopharynx, Salivary Glands or Supraglottic Region | ||||||||||||||||||||||||||||||
Brief Summary | The primary objective of the study is to assess the effect of RK-0202 versus placebo on the incidence and severity of oral mucositis in subjects receiving radiation therapy for head and neck cancer. Concurrent chemotherapy is not allowed in the study. | ||||||||||||||||||||||||||||||
Detailed Description | Approximately 42,000 new cases of head and neck squamous cell carcinoma occur annually in the United States. Radiotherapy (“RT”) plays a significant role in the management of head and neck cancer. The most common and clinically significant toxicities arising from head and neck radiation therapy are acute mucositis and acute and chronic xerostomia (dry mouth or salivary gland changes). In subjects receiving RT for cancers of the oral cavity or oropharynx the incidence of acute mucositis can exceed 90%. The painful ulceration of the oral mucosa produced by the radiation often leads to the requirement for narcotics to control pain, inability to eat, dehydration, the need for parenteral nutrition and, sometimes, breaks in RT. In addition to its symptomatic cost, the presence of mucositis has been associated with a number of other adverse outcomes including higher costs and more frequent hospitalizations. | ||||||||||||||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||||||||||||||
Study Phase | Phase 2 | ||||||||||||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Drug: RK-0202 | ||||||||||||||||||||||||||||||
Study Arms | Not Provided | ||||||||||||||||||||||||||||||
Publications * | Not Provided | ||||||||||||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||||||||||||||
Enrollment ICMJE |
110 | ||||||||||||||||||||||||||||||
Original Enrollment ICMJE | Same as current | ||||||||||||||||||||||||||||||
Study Completion Date | December 2005 | ||||||||||||||||||||||||||||||
Primary Completion Date | Not Provided | ||||||||||||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||||||||||||||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||||
Listed Location Countries ICMJE | Canada, United States | ||||||||||||||||||||||||||||||
Removed Location Countries | |||||||||||||||||||||||||||||||
Administrative Information | |||||||||||||||||||||||||||||||
NCT Number ICMJE | NCT00230191 | ||||||||||||||||||||||||||||||
Other Study ID Numbers ICMJE | RK:0202-02 | ||||||||||||||||||||||||||||||
Has Data Monitoring Committee | Not Provided | ||||||||||||||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||||||||||||||||||
IPD Sharing Statement | Not Provided | ||||||||||||||||||||||||||||||
Responsible Party | Not Provided | ||||||||||||||||||||||||||||||
Study Sponsor ICMJE | RxKinetix | ||||||||||||||||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||||||||||||||||
Investigators ICMJE |
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PRS Account | RxKinetix | ||||||||||||||||||||||||||||||
Verification Date | October 2005 | ||||||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |