Trial Outcomes & Findings for Scheduled Prophylactic Antiemetics for Reduction of Emesis With Doxycycline (SPARED) Trial (NCT NCT02456662)

NCT ID: NCT02456662

Last Updated: 2020-04-16

Results Overview

Number of participants experiencing symptoms (vomiting or nausea+vomiting) at the time of or after doxycycline

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 319 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2020-04-16

Participant Flow

757 participants were screened. 438 were excluded because they were not eligible or declined to participate. 319 were randomized to either placebo or Ondansetron.

Participant milestones

Measure	Placebo 160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive placebo tablet 30 minutes prior to taking 200mg PO doxycycline Placebo: placebo (identical to study medication- ondansetron) PO 30 minutes prior to 200mg PO doxycycline	Ondansetron 160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive 8mg ondansetron tablet 30 minutes prior to taking 200mg PO doxycycline Ondansetron: 8mg PO ondansetron 30 minutes prior to 200mg PO doxycycline
Overall Study STARTED	159	160
Overall Study COMPLETED	157	159
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Placebo 160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive placebo tablet 30 minutes prior to taking 200mg PO doxycycline Placebo: placebo (identical to study medication- ondansetron) PO 30 minutes prior to 200mg PO doxycycline	Ondansetron 160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive 8mg ondansetron tablet 30 minutes prior to taking 200mg PO doxycycline Ondansetron: 8mg PO ondansetron 30 minutes prior to 200mg PO doxycycline
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

Age data was not collected on one participant in the placebo arm.

Baseline characteristics by cohort

Measure	Placebo n=159 Participants 160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive placebo tablet 30 minutes prior to taking 200mg PO doxycycline Placebo: placebo (identical to study medication- ondansetron) PO 30 minutes prior to 200mg PO doxycycline	Ondansetron n=160 Participants 160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive 8mg ondansetron tablet 30 minutes prior to taking 200mg PO doxycycline Ondansetron: 8mg PO ondansetron 30 minutes prior to 200mg PO doxycycline	Total n=319 Participants Total of all reporting groups
Age, Continuous	26.0 years STANDARD_DEVIATION 5.8 • n=158 Participants • Age data was not collected on one participant in the placebo arm.	26.4 years STANDARD_DEVIATION 5.8 • n=160 Participants • Age data was not collected on one participant in the placebo arm.	26.2 years STANDARD_DEVIATION 5.79 • n=318 Participants • Age data was not collected on one participant in the placebo arm.
Sex: Female, Male Female	159 Participants n=159 Participants	160 Participants n=160 Participants	319 Participants n=319 Participants
Sex: Female, Male Male	0 Participants n=159 Participants	0 Participants n=160 Participants	0 Participants n=319 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=159 Participants	12 Participants n=160 Participants	27 Participants n=319 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	141 Participants n=159 Participants	147 Participants n=160 Participants	288 Participants n=319 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=159 Participants	1 Participants n=160 Participants	4 Participants n=319 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=159 Participants	3 Participants n=160 Participants	5 Participants n=319 Participants
Race (NIH/OMB) Asian	0 Participants n=159 Participants	3 Participants n=160 Participants	3 Participants n=319 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=159 Participants	1 Participants n=160 Participants	2 Participants n=319 Participants
Race (NIH/OMB) Black or African American	58 Participants n=159 Participants	57 Participants n=160 Participants	115 Participants n=319 Participants
Race (NIH/OMB) White	79 Participants n=159 Participants	81 Participants n=160 Participants	160 Participants n=319 Participants
Race (NIH/OMB) More than one race	13 Participants n=159 Participants	11 Participants n=160 Participants	24 Participants n=319 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=159 Participants	4 Participants n=160 Participants	10 Participants n=319 Participants
Region of Enrollment United States	159 participants n=159 Participants	160 participants n=160 Participants	319 participants n=319 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: This was an intent to treat analysis so all participants were included.

Number of participants experiencing symptoms (vomiting or nausea+vomiting) at the time of or after doxycycline

Outcome measures

Measure	Placebo n=159 Participants 160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive placebo tablet 30 minutes prior to taking 200mg PO doxycycline Placebo: placebo (identical to study medication- ondansetron) PO 30 minutes prior to 200mg PO doxycycline	Ondansetron n=160 Participants 160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive 8mg ondansetron tablet 30 minutes prior to taking 200mg PO doxycycline Ondansetron: 8mg PO ondansetron 30 minutes prior to 200mg PO doxycycline
Number of Participants Experiencing Symptoms	45 Participants	19 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ondansetron

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sarah Betstadt, MD, MPH

University of Rochester

Phone: 585-276-5367

Email: sarah_betstadt@urmc.rochester.edu

Results disclosure agreements

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