Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus With Radiofrequency Ablation

NCT02162758 | Terminated Phase 2 Results

• 2 other identifiers: DEX-P4-003U1111-1152-6767
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 6

Brief Summary

This study is designed to evaluate the effect of dexlansoprazole once daily (QD) and twice daily (BID) dosing on the recurrence of intestinal metaplasia (IM) in participants who achieved complete eradication of Barrett's esophagus (BE) with high-grade dysplasia (HGD) following radiofrequency ablation (RFA).

Conditions

Barrett's Esophagus

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Recurrence of Intestinal Metaplasia (IM)

  Recurrence of IM was defined as an esophageal biopsy result indicating BE with or without dysplasia.

  Month 12

Secondary Outcomes (3)

• Percentage of Participants With Recurrence of IM With Dysplasia

  Month 12

• Percentage of Participants With Erosive Esophagitis (EE)

  Baseline up to Month 12

• Change From Baseline in the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Total Score

  Baseline and Month 12

Study Arms (2)

Dexlansoprazole 60 milligram (mg) QD

EXPERIMENTAL

Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole 60 mg placebo-matching capsules, orally, once daily for up to 12 months.

Drug: Dexlansoprazole; Drug: Dexlansoprazole Placebo

Dexlansoprazole 60 mg BID

EXPERIMENTAL

Dexlansoprazole 60 mg, delayed-release capsules, orally, BID for up to 12 months.

Drug: Dexlansoprazole

Interventions

Dexlansoprazole DRUG

Dexlansoprazole delayed-release capsules

Also known as: Dexilant

Dexlansoprazole 60 mg BID; Dexlansoprazole 60 milligram (mg) QD

Dexlansoprazole Placebo DRUG

Dexlansoprazole placebo-matching capsules

Dexlansoprazole 60 milligram (mg) QD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is male or female and aged 18 to 80 years, inclusive.
• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
• Has a history of initial CEIM following radiofrequency ablation (RFA) for Barrett's esophagus with high-grade dysplasia or low grade dysplasia within the past 3 years.
• Had attained CEIM within 18 months of receiving his or her first RFA treatment.
• Has endoscopic and histologic confirmed evidence of CEIM prior to randomization.
• A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
• A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study.

You may not qualify if:

• Has evidence of cardiovascular, pulmonary, central nervous system, hepatic, hematopoietic, renal, metabolic, endocrine or gastrointestinal disease, or serious allergy, asthma, or allergic skin rash that suggests clinically significant, uncontrolled underlying disease or condition (other than the disease being studied), which may impact the ability of the participant to participate or potentially confound the study results.
• Had previous ablative therapy with a modality other than RFA for Barrett's esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, or laser treatment) with the exception of up to 3 treatments of thermal/coagulation therapy for focal residual disease following otherwise successful RFA therapy.
• Has a co-existing disease affecting the esophagus (example, erosive esophagitis, esophageal varices, scleroderma, viral or fungal infection, or esophageal stricture), history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus.
• Has a known history of eosinophilic esophagitis or endoscopic findings suggestive of eosinophilic esophagitis.
• Has active gastric or duodenal ulcers within 4 weeks prior to Day -1.
• Has any finding in his/her medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of underlying disease that might interfere with the conduct of the trial.
• Has a history of hypersensitivity or allergies to dexlansoprazole or any component of dexlansoprazole or any proton pump inhibitor (PPI) (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole) or antacid.
• Is required to take excluded medications or it is anticipated that the participant will require treatment with at least one of the disallowed concomitant medications during the study evaluation period as specified in the Excluded Medications and Treatments Section..
• Has a history of malignant disease (except basal cell carcinoma) within 5 years prior to Screening.
• Has a condition that may require inpatient surgery during the course of the study.
• Requires dilatation of esophageal strictures and/or strictures preventing passage of the endoscope during the Screening endoscopy. Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter) is acceptable.
• Is known to have acquired immunodeficiency syndrome.
• Has current or clinical history of Zollinger-Ellison syndrome or other hypersecretory condition.
• Has a history of gastric, duodenal or esophageal surgery except simple oversew of an ulcer. A history of gastric tube and/or percutaneous endoscopic gastrostomy (PEG) placement is allowed.
• Had an acute upper gastrointestinal hemorrhage within 4 weeks prior to endoscopy.

Sponsors & Collaborators

• Takeda: lead

Study Sites (6)

Unknown Facility

Jacksonville, Florida, 32216, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Chapel Hill, North Carolina, 27599, United States

Location

Unknown Facility

Chapel Hill, North Carolina, United States

Location

Unknown Facility

Knoxville, Tennessee, 37909, United States

Location

Unknown Facility

Knoxville, Tennessee, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Dexlansoprazole

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

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: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 13, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 11, 2017
• Results First Posted: May 11, 2017

Record last verified: 2017-03

Locations

US (6)