Safety and Efficacy Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn. - Full Text View

Sponsored by:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00251758

Purpose

The purpose of this study is to assess the efficacy and safety of daily treatment with Dexlansoprazole MR(60 mg or 90 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with GERD.

Condition	Intervention	Phase
Gastroesophageal Reflux Disease (GERD)	Drug: Dexlansoprazole Drug: Placebo	Phase III

MedlinePlus related topics: GERD Heartburn

Drug Information available for: Dexlansoprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR(60 mg QD and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

The mean percentage of days with neither daytime nor nighttime heartburn during treatment as assessed by daily electronic diary. [ Time Frame: Day -1(baseline) - Week 4 visit ] [ Designated as safety issue: No ]
Safety Assessment [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The mean percentage of days without nighttime heartburn during treatment as assessed by daily electronic diary. [ Time Frame: Day-1 (baseline) - Week 4 visit ] [ Designated as safety issue: No ]

Enrollment:	492
Study Start Date:	December 2005
Study Completion Date:	May 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Dexlansoprazole Dexlansoprazole 60 mg, capsules, orally, once daily for up to 28 days.
2: Experimental	Drug: Dexlansoprazole Dexlansoprazole 90 mg, capsules, orally, once daily for up to 28 days.
3: Placebo Comparator	Drug: Placebo Dexlansoprazole placebo-matching capsules, orally, once daily for up to 28 days.

Detailed Description:

This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of daily Dexlansoprazole MR(60 mg and 90 mg) with that of placebo when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate symptom relief in subjects with symptomatic non-erosive GERD. Approximately 450 subjects will be enrolled at approximately 120 U.S. and potentially ex U.S. sites. The study consists of two periods; a Screening Period, which will last a minimum of 7 days and a maximum of 21 days, and a treatment period, which will last 4 weeks.

Because the development plan for Dexlansoprazole MR was revised, the results of two identical studies, T-GD04-082 and T-GD04-083, were combined and analyzed as a single larger study, referred to as study T-GD04-082.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom as heartburn.
- History of episodes of heartburn for 6 months or longer prior to screening.
- History of episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the electronic diary.

Exclusion Criteria:

Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study
Erosive Esophagitis seen on endoscopy during study screening.
Co-existing diseases affecting the esophagus.
Abnormal laboratory values that suggest significant clinical disease.
Known AIDS
Females pregnant or lactating.
History of Alcohol abuse.
History of Cancer within 3 years prior to screening.
Chronic (>12 doses per month) use of NSAIDs or COX 2 inhibitors
Use of antacids [except for study supplied Gelusil® ]
Use of drugs with significant anticholinergic effects
Need for continuous anticoagulant (blood thinner) therapy
Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition
History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer
Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251758

Show 99 Study Locations

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

Medical Director

Takeda Global Research & Development Center, Inc.

More Information

Responsible Party:	Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science )
Study ID Numbers:	T-GD04-083
Study First Received:	November 8, 2005
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00251758
Health Authority:	United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:

Non-Erosive Gastroesophageal Reflux Disease(GERD),heartburn

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Pyrosis
Digestive System Diseases
Esophageal disorder

Gastrointestinal Diseases
Heartburn
Esophageal Diseases
Gastroesophageal Reflux

ClinicalTrials.gov processed this record on January 16, 2009