Trial Outcomes & Findings for Efficacy of SNX-1012 in the Treatment of Oral Mucositis (NCT NCT00385515)

Last Updated: 2009-05-07

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

81 participants

Primary outcome timeframe

At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle

Results posted on

2009-05-07

Participant Flow

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

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	57	24
Overall Study COMPLETED	53	21
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of SNX-1012 in the Treatment of Oral Mucositis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SNX-1012 n=57 Participants SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days	Placebo n=24 Participants Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days	Total n=81 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants	18 Participants n=7 Participants	66 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Age Continuous	51.3 years STANDARD_DEVIATION 12.9 • n=5 Participants	54.5 years STANDARD_DEVIATION 12.0 • n=7 Participants	52.3 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	24 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	17 participants n=7 Participants	56 participants n=5 Participants
Region of Enrollment India	18 participants n=5 Participants	7 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle

Population: Analysis only includes subjects randomized to the 30mg dose of SNX-1012

Outcome measures

Outcome measures
Measure	SNX-1012 n=44 Participants SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days	Placebo n=21 Participants Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
Duration of Ulcerative Oral Mucositis	2.3 Days Standard Deviation 3.04	3.2 Days Standard Deviation 4.68

SECONDARY outcome

Timeframe: At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle

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.

Outcome measures

Outcome measures
Measure	SNX-1012 n=44 Participants SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days	Placebo n=21 Participants Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
Number of Participants With Ulcerative Oral Mucositis	22 Participants	11 Participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eward G. Fey, PhD

Mucosal Therapeutics, LLC

Phone: 857-228-1100

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER