Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets

NCT02096458 | Completed Phase 1 Results

• 2 other identifiers: TAK-390MR(OD)_107U1111-1152-9255
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease; Erosive Esophagitis; Heartburn

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Time to In-Vivo Disintegration of Dexlansoprazole 30 mg Orally Disintegrating Tablets

  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.

  Day 1

Study Arms (1)

Dexlansoprazole 30 mg

EXPERIMENTAL

Dexlansoprazole 30 mg delayed-release orally disintegrating tablets at Assessment 1 Day 1, Assessment 2 Day 1, and Assessment 3 Day 1.

Drug: Dexlansoprazole

Interventions

Dexlansoprazole DRUG

Dexlansoprazole delayed-release orally disintegrating tablets

Dexlansoprazole 30 mg

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• 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.

You may not qualify if:

• 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.
• If female, the sensory panelist is pregnant, nursing, planning to become pregnant during the study.
• 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).
• Is currently taking any contraindicated medications.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Woburn, Massachusetts, 01801, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Interventions

Dexlansoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lansoprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Takeda Study Registration Call Center
• Organization: Takeda Development Center Americas, Inc.

medicalinformation@tpna.com

800-778-2860

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: March 26, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 6, 2015
• Results First Posted: March 6, 2015

Record last verified: 2015-02

Locations

US (1)