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Efficacy of SNX-1012 in the Treatment of Oral Mucositis

This study has been completed.
Sponsor:
Information provided by:
Mucosal Therapeutics
ClinicalTrials.gov Identifier:
NCT00385515
First received: October 5, 2006
Last updated: April 8, 2009
Last verified: April 2009
History of Changes
Results First Received: January 19, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Stomatitis
Oral Mucositis
Interventions: Drug: SNX-1012 (meclocycline sulfosalicylate)
Drug: placebo

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
SNX-1012 SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
Placebo Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
Total Total of all reporting groups

Baseline Measures
    SNX-1012     Placebo     Total  
Number of Participants  
[units: participants]
 		  57     24     81  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     48     18     66  
>=65 years     9     6     15  
Age  
[units: years]
Mean ± Standard Deviation 		  51.3  ± 12.9     54.5  ± 12.0     52.3  ± 12.6  
Gender  
[units: participants]
 		     
Female     53     24     77  
Male     4     0     4  
Region of Enrollment  
[units: participants]
 		     
United States     39     17     56  
India     18     7     25  



  Outcome Measures
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1.  Primary:   Duration of Ulcerative Oral Mucositis   [ Time Frame: At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle ]
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2.  Secondary:   Number of Participants With Ulcerative Oral Mucositis   [ Time Frame: At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Eward G. Fey, PhD
Organization: Mucosal Therapeutics, LLC
phone: 857-228-1100


No publications provided


Responsible Party: Marna Doucette, Coserics
ClinicalTrials.gov Identifier: NCT00385515     History of Changes
Other Study ID Numbers: SNX-1012-CLN2-006
Study First Received: October 5, 2006
Results First Received: January 19, 2009
Last Updated: April 8, 2009
Health Authority: United States: Food and Drug Administration