Barrett's EsophagusPhase 2NCT02162758
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
A Phase 2 study testing Dexlansoprazole in people with Barrett's Esophagus, run by Takeda at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- Dexlansoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2014to Apr 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 23Show fewer
- 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.
- Has donated or lost greater than or equal to (>=)300 milliliter (mL) blood volume, undergone plasmapheresis, or has had a transfusion of any blood product within 90 days prior to the first dose of study drug.
- Has a known history of alcohol abuse or illegal drug use within the past 12 months prior to the first dose of study drug, or is unwilling to agree to abstain from alcohol or illegal drug use throughout the study.
- If female, the participant is pregnant or lactating or intending to become pregnant before, during or within 30 days after last dose of study medication; or intending to donate ova during such time period.
- If male, the participant intends to donate sperm during the course of this study or within 30 days after last dose of study drug.
- Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study or may consent and assent under duress. Students of the institution/research facility who are under the supervision of, or in a subordinate role to, the investigator are also ineligible.
- In the opinion of the investigator, is unlikely to comply with the protocol requirements or is unsuitable for any other reason.
- Has been previously randomized in this study and received at least one dose of double blind study drug treatment.
- Has received any investigational compound within 30 days prior to Screening.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Chapel Hill, North Carolina, 27599
Study site
Chapel Hill, North Carolina
Study site
Jacksonville, Florida, 32216
Study site
Jacksonville, Florida
Study site
Knoxville, Tennessee, 37909
Study site
Knoxville, Tennessee
About this study
Official title: A Randomized, Double-Blind, Phase 4 Study to Evaluate the 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
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).
Read the detailed description
The drug being tested in this study is called dexlansoprazole. The purpose of this study is to evaluate the effect of 12 months of treatment with dexlansoprazole 60 mg QD or dexlansoprazole 60 mg BID on the recurrence of IM in participants who have achieved complete eradication of intestinal metaplasia (CEIM) and dysplasia (CED) with RFA. The study will enroll approximately 150 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- Dexlansoprazole 60 mg once a day and placebo (this is a capsule that looks like the study drug but has no active ingredient) once a day
- Dexlansoprazole 60 mg twice a day.
All participants will be asked to take one capsule twice a day at the same time each day throughout the study.
This randomized, double-blind, multi-center, parallel group trial will be conducted in North America. The overall time to participate in this study is up to 13 months. Participants will make 5 visits to the clinic, and will undergo a safety follow-up assessment 30 days after the last dose of study drug.
- Conditions
- Barrett's Esophagus
- Being tested
- Dexlansoprazole, Dexlansoprazole Placebo
- Keywords
- Drug therapy
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexlansoprazoleDrug
Also called Dexilant
Dexlansoprazole delayed-release capsules
Dexlansoprazole PlaceboDrug
Dexlansoprazole placebo-matching capsules
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dexlansoprazole; Drug: Dexlansoprazole Placebo |
| Dexlansoprazole 60 mg BID | Experimental | Dexlansoprazole 60 mg, delayed-release capsules, orally, BID for up to 12 months. Receives: Drug: Dexlansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 12
Secondary outcomes (3)
Percentage of Participants With Recurrence of IM With Dysplasia
Recurrence of IM with dysplasia was defined as an esophageal biopsy result indicating BE with dysplasia.
Measured: Month 12
Percentage of Participants With Erosive Esophagitis (EE)
The severity of EE was classified into following grades: Grade A: one or more mucosal breaks no longer than 5 millimeter (mm), none of which extends between the tops of the mucosal folds; Grade B: one or more mucosal breaks more than 5 mm long, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve less than 75 percent (%) of the esophageal circumference; Grade D: mucosal breaks which involve at least 75% of the esophageal circumference.
Measured: Baseline up to Month 12
Change From Baseline in the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Total Score
The GERD-HRQL score consisted of 10 questions, where participants were required to answer each question on a scale of 0 to 5 (0: no symptoms; 1: symptoms noticeable but not bothersome; 2: symptoms noticeable and bothersome but not every day; 3: symptoms bothersome every day; 4: symptoms affect daily activity; 5: symptoms are incapacitating to do daily activities). The total score was derived by simply adding the individual score of each question. The total score ranged from 0 to 50 where a higher score indicated more severe disease. The best possible total GERD-HRQL score was 0 (asymptomatic in all questions) and the worst possible score is 50 (incapacitated in all questions).
Measured: Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Business Decisions; No Safety Concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162758
- Sponsor's protocol ID
- DEX-P4-003
- Other IDs
- U1111-1152-6767
- Status last verified
- Mar 2017
- First submitted
- 10 Jun 2014
- Last updated
- 11 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase 4 Study to Evaluate the 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
- ClinicalTrials.gov ID
- NCT02162758
- Acronym / sponsor ID
- DEX-P4-003
- Conditions
- Barrett's Esophagus
- Keywords
- Drug therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decisions; No Safety Concerns
- Enrolment
- 6 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Posted 11 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The drug being tested in this study is called dexlansoprazole. The purpose of this study is to evaluate the effect of 12 months of treatment with dexlansoprazole 60 mg QD or dexlansoprazole 60 mg BID on the recurrence of IM in participants who have achieved complete eradication of intestinal metaplasia (CEIM) and dysplasia (CED) with RFA. The study will enroll approximately 150 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- Dexlansoprazole 60 mg once a day and placebo (this is a capsule that looks like the study drug but has no active ingredient) once a day
- Dexlansoprazole 60 mg twice a day.
All participants will be asked to take one capsule twice a day at the same time each day throughout the study.
This randomized, double-blind, multi-center, parallel group trial will be conducted in North America. The overall time to participate in this study is up to 13 months. Participants will make 5 visits to the clinic, and will undergo a safety follow-up assessment 30 days after the last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexlansoprazole 60 milligram (mg) QD | Experimental | Drug: Dexlansoprazole, Drug: Dexlansoprazole PlaceboDexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole 60 mg placebo-matching capsules, orally, once daily for up to 12 months. |
| Dexlansoprazole 60 mg BID | Experimental | Drug: DexlansoprazoleDexlansoprazole 60 mg, delayed-release capsules, orally, BID for up to 12 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexlansoprazoleAlso: DexilantDexlansoprazole delayed-release capsules | Drug | Dexlansoprazole 60 mg BID, Dexlansoprazole 60 milligram (mg) QD |
| Dexlansoprazole PlaceboDexlansoprazole placebo-matching capsules | Drug | Dexlansoprazole 60 milligram (mg) QD |
Primary outcome
Percentage of Participants With Recurrence of Intestinal Metaplasia (IM)
Time frame: Month 12
Recurrence of IM was defined as an esophageal biopsy result indicating BE with or without dysplasia.
3 secondary outcomes
Percentage of Participants With Recurrence of IM With Dysplasia
Time frame: Month 12
Percentage of Participants With Erosive Esophagitis (EE)
Time frame: Baseline up to Month 12
Change From Baseline in the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Total Score
Time frame: Baseline and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Barrett's Esophagus
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Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
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"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
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Lucid BE Biomarkers Study
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Impact of RFA on Esophageal Distensibility and Mucosal Impedance
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director Clinical Science study director
Takeda
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexlansoprazole in people with Barrett's Esophagus, run by Takeda at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Recurrence of Intestinal Metaplasia (IM) (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.