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Oral mucositis (OM) is a common and debilitating toxicity induced by many chemotherapy (CT) regimens and by radiation to the head and neck. The purpose of this study is to determine the effectiveness of SNX-1012 in decreasing the duration of Grade 2, 3, or 4 oral mucositis (OM) according to World Health Organization (WHO) criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | SNX-1012 (meclocyline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg 4 times daily for 10 days |
|
| 2 | Placebo Comparator | placebo (matched to SNX-1012) tablets dissolved in water for oral swish and expectorate; 4 times daily for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNX-1012 (meclocycline sulfosalicylate) | Drug | tablets to be dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Ulcerative Oral Mucositis | All randomized subjects were directly observed by trained evaluators for at least 10 consecutive days during the chemotherapy cycle to document the duration for those that developed recurrent ulcerative oral mucositis | At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Ulcerative Oral Mucositis | All randomized subjects were directly observed by trained evaluators for at least 10 consecutive days during the chemotherapy cycle to identify recurrence of ulcerative oral mucositis. | At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle |
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Inclusion Criteria:
Hemoglobin (Hgb) level >= 9 g/dL Absolute neutrophil count (ANC) >= 1.5 x 10 to the 9/L Platelet count >= 100 x 10 to the 9/L Serum bilirubin level <= 1.5 times institutional upper limit of normal (ULN) Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) level <= 2 times above ULN
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desert Hematology Oncology Medical Group | Rancho Mirage | California | 92270 | United States | ||
| Bridgeport Hospital |
533 subjects were screened during a chemotherapy cycle and those that developed ulcerative oral mucositis and fully recovered were randomized to treatment with study drug during the next chemotherapy cycle
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| ID | Title | Description |
|---|---|---|
| FG000 | SNX-1012 | SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days |
| FG001 | Placebo | Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Drug | Tablets to be dissolved in water for oral swish and expectorate; placebo, 4 times daily for 10 days |
|
| Bridgeport |
| Connecticut |
| 06610 |
| United States |
| Eastern Connecticut Hematology & Oncology Associates | Norwich | Connecticut | 06360 | United States |
| Florida Research Cancer Institute | Davie | Florida | 33328 | United States |
| Park Nicollet Clinic | Saint Louis Park | Minnesota | 55416 | United States |
| Capitol Comprehensive Cancer Care Clinic | Jefferson City | Missouri | 65109 | United States |
| Cancer Specialists of South Texas | Corpus Christi | Texas | 78412 | United States |
| Cancer Outreach Associates | Abingdon | Virginia | 24211 | United States |
| Morgantown Internal Medicine Group | Morgantown | West Virginia | 26505 | United States |
| Vedanta Institute of Medical Sciences | Navrangpura | Ahmedabad, Gujarat | 380009 | India |
| Jawaharlal Nehru Cancer Hospital and Research Centre | Post Box No. 32, Idgah Hills | Bhopal, Madhya Pradesh | 462001 | India |
| Apollo Speciality Hospital | 320, Mount Road, Teynampet | Chennai, Tamil Nadu | 600035 | India |
| Apollo Hospitals | Jubilee Hills | Hyderabad, Andhra Pradesh | 500033 | India |
| Nizams Institute of Medical Sciences | Punjagutta | Hyderabad, Andhra Pradesh | 500082 | India |
| Bhagwan Mahavir Cancer Hospital and Research Centre, | Jawaharlal Nehru Marg | Jaipur, Rajasthan | 302017 | India |
| S.K Sony Hospital, Vidyadhar Nagar, | Sector-5 Sikar Road | Jaipur, Rajasthan | 302013 | India |
| Netaji Subhash Chandra Bose Cancer Hospital & Research Institute | 16A Park Lane | Kolkatta, West Bengal | 700016 | India |
| Chittaranjan National Cancer Institute | 37, S.P. Mukherjee Rd. | Kolkatta, West Bengal | 700026 | India |
| Dayanand Medical College & Hospital | Tagore Nagar, Civil Lines | Ludhiana, Punjab | 141001 | India |
| Jaslok Hospital & Research Centre | 15-Dr. G. Deshmukh Marg | Mumbai, Maharashtra | 400026 | India |
| Dharamshila Cancer Hospital and Research Centre, | Dharamshila Marg, Vasundhara Enclave | National Capital Territory of Delhi | 110096 | India |
| Jehangir Hospital, | 32 Sassoon Road | Pune, Maharashtra | 411001 | India |
| Ruby Hall Clinic, | 40, Sassoon Road | Pune, Maharashtra | 411001 | India |
| Seth Ramdas Shah Memorial Hospital & Research Centre | Fp-402, Gokhle Nagar Road, Shivaji Nagar | Pune, Maharashtra | 411016 | India |
| North Bengal Oncology Centre, | Pradhan Nagar | Siliguri, Dist- Darjeeling, West Bengal | 734003 | India |
| Regional Cancer Centre | Medical College Campus, Post Bag No. 2417 | Trivandrum, Kerala | 695011 | India |
| Christian Medical College & Hospital | IDA Scuddar Road | Vellore, Tamil Nadu | 632004 | India |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SNX-1012 | SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days |
| BG001 | Placebo | Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Ulcerative Oral Mucositis | All randomized subjects were directly observed by trained evaluators for at least 10 consecutive days during the chemotherapy cycle to document the duration for those that developed recurrent ulcerative oral mucositis | Analysis only includes subjects randomized to the 30mg dose of SNX-1012 | Posted | Mean | Standard Deviation | Days | At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Ulcerative Oral Mucositis | All randomized subjects were directly observed by trained evaluators for at least 10 consecutive days during the chemotherapy cycle to identify recurrence of ulcerative oral mucositis. | Posted | Number | Participants | At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle |
|
|
Individual investigators are restricted from disclosure of results until 24 months after the completion of the Study at all participating research centers. Sponsor can review results communication 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eward G. Fey, PhD | Mucosal Therapeutics, LLC | 857-228-1100 |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C100122 | meclocycline |
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| >=65 years |
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| Male |
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| India |
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