Trial Outcomes & Findings for Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets (NCT NCT02096458)

Results Overview

The disintegration time is the total time from when the participant places the tablet on their tongue until the time at which the participant would normally swallow the remaining materials from the disintegrated tablet. The average disintegration time will be calculated for each participant based on 3 separate tests.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

8 participants

Primary outcome timeframe

Day 1

Results posted on

2015-03-06

Participant Flow

A total of 8 participants were screened for the study, and all participants subsequently enrolled.

Participant milestones

Participant milestones
Measure	Dexlansoprazole Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexlansoprazole n=8 Participants Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
Age, Continuous	56.5 Years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: The populations consisted of all enrolled participants.

The disintegration time is the total time from when the participant places the tablet on their tongue until the time at which the participant would normally swallow the remaining materials from the disintegrated tablet. The average disintegration time will be calculated for each participant based on 3 separate tests.

Outcome measures

Outcome measures
Measure	Dexlansoprazole n=8 Participants Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
Time to In-Vivo Disintegration of Dexlansoprazole 30 mg Orally Disintegrating Tablets	36.0 Seconds Interval 30.7 to 39.3

Adverse Events

Dexlansoprazole

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

Takeda Study Registration Call Center

Takeda Development Center Americas, Inc.

Phone: 800-778-2860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
Publication restrictions are in place

Restriction type: OTHER