Trial Outcomes & Findings for Study to Evaluate Safety and Efficacy of Rifamycin SV Multi-Matrix System (MMX) for the Treatment of Traveler's Diarrhea (TD) (NCT NCT01142089)

NCT ID: NCT01142089

Last Updated: 2018-06-08

Results Overview

The primary endpoint is TLUS defined as the interval in hours between the first dose of study drug and the last unformed stool passed just before the start of Clinical Cure. An unformed stool is defined as either a soft or watery stool. TLUS will be calculated for each patient in the following manner: Step 1: Identify when the patient achieves Clinical Cure. Step 2: Moving backwards from this time, identify the time of the last unformed stool. Step 3: The TLUS equals the time from the first dose of study drug to the time of the last unformed stool identified in Step 2.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

264 participants

Primary outcome timeframe

24 hours

Results posted on

2018-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo (two matching tablets) orally twice daily for 3 days (72 hours) Placebo: Placebo (two matching tablets) orally twice daily for 3 days (72 hours). Intent To Treat (ITT)	Rifamycin SV MMX Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours). Rifamycin SV MMX: Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours). Intent To Treat (ITT)
Overall Study STARTED	65	199
Overall Study COMPLETED	53	178
Overall Study NOT COMPLETED	12	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo (two matching tablets) orally twice daily for 3 days (72 hours) Placebo: Placebo (two matching tablets) orally twice daily for 3 days (72 hours). Intent To Treat (ITT)	Rifamycin SV MMX Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours). Rifamycin SV MMX: Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours). Intent To Treat (ITT)
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	1	2
Overall Study Use of prohibited medications	0	1
Overall Study Noncompliance with study procedures	2	1
Overall Study Patient required rescue medication	8	17

Baseline Characteristics

Study to Evaluate Safety and Efficacy of Rifamycin SV Multi-Matrix System (MMX) for the Treatment of Traveler's Diarrhea (TD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=65 Participants Placebo (two matching tablets) orally twice daily for 3 days (72 hours) Placebo: Placebo (two matching tablets) orally twice daily for 3 days (72 hours). Intent To Treat (ITT)	Rifamycin SV MMX n=199 Participants Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours). Rifamycin SV MMX: Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours). Intent To Treat (ITT)	Total n=264 Participants Total of all reporting groups
Age, Continuous	28.9 years STANDARD_DEVIATION 12.72 • n=5 Participants	28 years STANDARD_DEVIATION 11.43 • n=7 Participants	28.3 years STANDARD_DEVIATION 11.74 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	100 Participants n=7 Participants	133 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	99 Participants n=7 Participants	131 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) White	56 Participants n=5 Participants	175 Participants n=7 Participants	231 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Baseline Pathogen Identified Yes	48 Participants n=5 Participants	133 Participants n=7 Participants	181 Participants n=5 Participants
Baseline Pathogen Identified No	17 Participants n=5 Participants	66 Participants n=7 Participants	83 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Intent To Treat (ITT). Please note that the 75th percentile was not observed during the 120-hour study period for placebo patients. The percentile groups indicate the hour at which the appropriate percentage of the patient group had met the primary endpoint i.e. by 72 hours, 75% of Rifamycin SV MMX patients had met the endpoint.

Outcome measures

Outcome measures
Measure	Placebo n=65 Participants Placebo (two matching tablets) orally twice daily for 3 days (72 hours) Placebo: Placebo (two matching tablets) orally twice daily for 3 days (72 hours). Intent To Treat (ITT)	Rifamycin SV MMX n=199 Participants Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours). Rifamycin SV MMX: Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours). Intent To Treat (ITT)
Time to Last Unformed Stool (TLUS) 25th percentile	37.4 TLUS (hours) Interval 8.3 to 47.8	21. TLUS (hours) Interval 12.7 to 25.8
Time to Last Unformed Stool (TLUS) 50th percentile	68 TLUS (hours) Interval 48.7 to The 75th percentile was not observed during the 120-hour study period for placebo patients.	46 TLUS (hours) Interval 42.8 to 50.5
Time to Last Unformed Stool (TLUS) 75th percentile	NA TLUS (hours) the 75th percentile was not observed during the 120-hour study period for placebo patients.	72.2 TLUS (hours) Interval 69.0 to 91.7

SECONDARY outcome

Timeframe: 24 hours

Population: Intent to treat (ITT)

Clinical Cure is defined as either of the following: * Passage of two or fewer soft stools and no watery stools, no fever (\>100.4 ºF or 38 ºC), and no signs or symptoms of enteric infection (other than mild excess gas/flatulence) during a 24 hour interval in the 120-hr data collection period after the first dose of study drug * Passage of no stools or only formed stools and no fever during a 48-hour interval in the 120-hr data collection period after the first dose of study drug, with or without other signs or symptoms of enteric infection

Outcome measures

Outcome measures
Measure	Placebo n=65 Participants Placebo (two matching tablets) orally twice daily for 3 days (72 hours) Placebo: Placebo (two matching tablets) orally twice daily for 3 days (72 hours). Intent To Treat (ITT)	Rifamycin SV MMX n=199 Participants Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours). Rifamycin SV MMX: Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours). Intent To Treat (ITT)
Clinical Cure	35 Participants	162 Participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Rifamycin SV MMX

Serious events: 2 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=65 participants at risk Placebo (two matching tablets) orally twice daily for 3 days (72 hours) Placebo: Placebo (two matching tablets) orally twice daily for 3 days (72 hours). Intent To Treat (ITT)	Rifamycin SV MMX n=199 participants at risk Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours). Rifamycin SV MMX: Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours). Intent To Treat (ITT)
Infections and infestations Clostridium difficile colitis	1.5% 1/65 • Number of events 1 • The Investigator must completely and promptly record each new AE/SAE that occurs after the first dose of study drug through Visit 4 (i.e., treatment emergent AEs) on the appropriate CRF, even if the relationship of an AE to study drug is assessed by the Investigator to be "unlikely" or "not related". In addition, the investigator must document and follow SAEs that occur from Visit 4 through 30 days after the last dose of study drug.	0.00% 0/199 • The Investigator must completely and promptly record each new AE/SAE that occurs after the first dose of study drug through Visit 4 (i.e., treatment emergent AEs) on the appropriate CRF, even if the relationship of an AE to study drug is assessed by the Investigator to be "unlikely" or "not related". In addition, the investigator must document and follow SAEs that occur from Visit 4 through 30 days after the last dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroblastoma	0.00% 0/65 • The Investigator must completely and promptly record each new AE/SAE that occurs after the first dose of study drug through Visit 4 (i.e., treatment emergent AEs) on the appropriate CRF, even if the relationship of an AE to study drug is assessed by the Investigator to be "unlikely" or "not related". In addition, the investigator must document and follow SAEs that occur from Visit 4 through 30 days after the last dose of study drug.	0.50% 1/199 • Number of events 1 • The Investigator must completely and promptly record each new AE/SAE that occurs after the first dose of study drug through Visit 4 (i.e., treatment emergent AEs) on the appropriate CRF, even if the relationship of an AE to study drug is assessed by the Investigator to be "unlikely" or "not related". In addition, the investigator must document and follow SAEs that occur from Visit 4 through 30 days after the last dose of study drug.
Gastrointestinal disorders Abdominal pain/vomiting	0.00% 0/65 • The Investigator must completely and promptly record each new AE/SAE that occurs after the first dose of study drug through Visit 4 (i.e., treatment emergent AEs) on the appropriate CRF, even if the relationship of an AE to study drug is assessed by the Investigator to be "unlikely" or "not related". In addition, the investigator must document and follow SAEs that occur from Visit 4 through 30 days after the last dose of study drug.	0.50% 1/199 • Number of events 1 • The Investigator must completely and promptly record each new AE/SAE that occurs after the first dose of study drug through Visit 4 (i.e., treatment emergent AEs) on the appropriate CRF, even if the relationship of an AE to study drug is assessed by the Investigator to be "unlikely" or "not related". In addition, the investigator must document and follow SAEs that occur from Visit 4 through 30 days after the last dose of study drug.

Other adverse events

Additional Information

Richard Jones

Cosmo Technologies Ltd.

Phone: +35318170370

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Principal Investigator will provide Sponsor an opportunity of at least 30 days to review and comment on any proposed publication before it is disclosed and Sponsor shall have the right to require the removal of any Confidential Information. Sponsor shall have the right to require the publication be delayed for an additional period not to exceed 60 days to permit the filing of patent applications or to seek intellectual property protection related to information contained in such publication.
Publication restrictions are in place

Restriction type: OTHER