Trial Outcomes & Findings for The Effects of Dexlansoprazole for the Treatment of Throat-Related Reflux (NCT NCT01317472)

Results Overview

The Reflux Symptom Index (RSI) is a 9-item measure with each symptom rated from 0 (no problem) to 5 (severe problem), for a total possible range of 0 (no problem) to 45 (severe problem). An RSI of \>13 is considered to be abnormal.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

Baseline to 2 months

Results posted on

2019-10-01

Participant Flow

Participant milestones

Participant milestones
Measure	Dexlansoprazole Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC). dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months	Sugar Pill Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC) or 1 tablet of placebo QAM (1 hour AC). dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months
Overall Study STARTED	9	2
Overall Study COMPLETED	7	2
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Dexlansoprazole Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC). dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months	Sugar Pill Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC) or 1 tablet of placebo QAM (1 hour AC). dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months
Overall Study Withdrawal by Subject	1	0
Overall Study Unrelated hospitalization	1	0

Baseline Characteristics

The Effects of Dexlansoprazole for the Treatment of Throat-Related Reflux

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexlansoprazole n=9 Participants Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC). dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months	Sugar Pill n=2 Participants Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC) or 1 tablet of placebo QAM (1 hour AC). dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months	Total n=11 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	9 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 2 months

The Reflux Symptom Index (RSI) is a 9-item measure with each symptom rated from 0 (no problem) to 5 (severe problem), for a total possible range of 0 (no problem) to 45 (severe problem). An RSI of \>13 is considered to be abnormal.

Outcome measures

Outcome measures
Measure	Dexlansoprazole n=7 Participants Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC). dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months	Sugar Pill n=2 Participants Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC) or 1 tablet of placebo QAM (1 hour AC). dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months
Change in Reflux Symptom Index (RSI)	18 units on a scale Standard Deviation 3.95	13 units on a scale Standard Deviation 4.54

Adverse Events

Dexlansoprazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill

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

Terese Stevens, Dept administrator

Indiana University

Phone: 317-278-3187

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place