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Trial record 1 of 1 for:    TAK-390MR(OD)_107
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Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets

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ClinicalTrials.gov Identifier: NCT02096458
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : March 6, 2015
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to measure the in-vivo disintegration time of a single dexlansoprazole delayed-release orally disintegrating (OD) tablet.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Erosive Esophagitis Heartburn Drug: Dexlansoprazole Phase 1

Detailed Description:

The drug being tested in this study is called dexlansoprazole. An orally disintegrating (OD) form of dexlansoprazole is being tested to look at the average time that it takes for one tablet to disintegrate in the mouth of healthy volunteers. At the point at which the panelist would normally swallow the granules, they will record the time and expectorate the disintegrated tablet mass and not actually swallow the tablet or granules.

The study will enroll approximately 8 healthy volunteers. All participants will take one dexlansoprazole 30 mg OD tablet on up to three separate study days. No more than 60 mg of dexlansoprazole will be tested in any one day.

This single-centre trial will be conducted in the United States. The overall time to participate in this study is approximately 2 weeks. Participants will make up to 4 visits to the clinic, and will be contacted by telephone approximately 1 week after last dose of study drug for a follow-up assessment.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Subjects : TAK-390MR(OD)_107
Study Start Date : February 2014
Primary Completion Date : February 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Dexlansoprazole 30 mg
Dexlansoprazole 30 mg delayed-release orally disintegrating tablets at Assessment 1 Day 1, Assessment 2 Day 1, and Assessment 3 Day 1.
Drug: Dexlansoprazole
Dexlansoprazole delayed-release orally disintegrating tablets



Primary Outcome Measures :
  1. Time to In-Vivo Disintegration of Dexlansoprazole 30 mg Orally Disintegrating Tablets [ Time Frame: Day 1 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The male or female sensory panelist is between 25 and 80 years of age (inclusive), healthy volunteers for study participation, and is able to read, understand, and sign and date a written informed consent form (ICF) and any required privacy authorization before study participation.
  2. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  3. The sensory panelist is qualified based on documented training and experience: All panelists will be provided by Senopsys, LLC: Panelists have been trained to detect, identify, recognize, and accurately describe different taste elements and flavor combinations and to measure oral disintegration times. Training is initially accomplished by tasting model compounds and learning to recognize and describe these accurately. These abilities are then honed and refined through additional experience in performing product testing.

Exclusion Criteria:

  1. Has a history of any illness that, in the opinion of the investigator or the sensory panelist's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the sensory panelist. This may include but is not limited to: a history of relevant drug or food allergies; history of cardiovascular or central nervous system disease; history or presence of clinically significant pathology; recent history of disease involving head, neck, esophagus (especially malignancy, radiation therapy, fungal infection where taste perception can be altered) or history of mental disease.
  2. If female, the sensory panelist is pregnant, nursing, planning to become pregnant during the study.
  3. Has a known hypersensitivity to dexlansoprazole or any component of dexlansoprazole delayed-release orally disintegrating (OD) tablet or proton pump inhibitor (PPI) (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole).
  4. Is currently taking any contraindicated medications.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096458


Locations
United States, Massachusetts
Woburn, Massachusetts, United States, 01801
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Clinical Science Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02096458     History of Changes
Other Study ID Numbers: TAK-390MR(OD)_107
U1111-1152-9255 ( Other Identifier: World Health Organization )
First Posted: March 26, 2014    Key Record Dates
Results First Posted: March 6, 2015
Last Update Posted: March 6, 2015
Last Verified: February 2015

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Dexlansoprazole
Lansoprazole
Gastroesophageal Reflux
Esophagitis
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action