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Gastroesophageal Reflux DiseasePhase 2NCT01642615

Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents

A Phase 2 study testing Dexlansoprazole in people with Gastroesophageal Reflux Disease and Erosive Esophagitis, run by Takeda at 60 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules in adolescents with erosive esophagitis (EE) and for maintenance of healed EE and relief of heartburn. Read more about this study

Who is it for?
Ages 12 to 17 years
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
63 participants
Where
60 sitesin 8 countries
Study dates
Jul 2012to Nov 2014
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 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • In the opinion of the investigator, the participant and parent(s) or legal guardian are capable of understanding and complying with protocol requirements.
  • Prior to any study-specific procedures being performed, the informed consent and the assent form, according to local country requirements, must be signed and dated by parent(s) or legal guardian and by the participant respectively.
  • The participant has a medical history of symptoms of Gastroesophageal Reflux Disease (GERD) for at least 3 months prior to Screening (signed informed consent form and assent, if applicable) as assessed by the investigator.
  • The participant has met the electronic diary qualification criteria as assessed by the electronic daily diary defined as follows: heartburn (burning or hurting in your throat, chest, or stomach) on at least 3 of 7 days.(Note: if an endoscopy done within 1 week of signing informed consent and assent is used to confirm diagnosis of EE, the subject does not need to meet this criterion).
  • The participant has endoscopic evidence of EE (LA Grade A-D) based on the screening endoscopy.
  • The participant is male or female and aged 12 to 17 years, inclusive.
  • 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 and assent throughout the duration of the study and for 30 days after last dose of study medication.
  • A female participant of childbearing potential who is or may become sexually active agrees to routinely use adequate contraception from the time of signing the informed consent and assent until 30 days after the last dose of study medication.

Who cannot join

  • Participant 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.
  • The participant has a co-existing disease affecting the esophagus (eg, 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.
  • The participant has known history of Barrett's with dysplastic changes in the esophagus.
  • The participant has a known history of eosinophilic esophagitis (EoE) or endoscopic findings suggestive of EoE.
  • The participant has a history of celiac disease or participant tests positive for tissue transglutaminase (tTG) antibody.
  • The participant has active gastric or duodenal ulcers within 4 weeks prior to Day -1.
Show all 26Show fewer
  • Participant 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.
  • Participant has taken any proton pump inhibitor (PPI) within 1 week (7 days) prior to the Screening Visit.
  • Participant tests positive for H. pylori.
  • The participant has a history of hypersensitivity or allergies to dexlansoprazole or any component of dexlansoprazole or any PPI (including lansoprazole, omeprazole, rabeprazole, pantoprazole, or esomeprazole) or antacid containing Mg(OH)2 and/or Al(OH)3 or simethicone.
  • The participant 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 7.3.
  • The participant has a history of malignant disease (except basal cell carcinoma) within 5 years prior to Screening.
  • The participant has a condition that may require inpatient surgery during the course of the study.
  • The participant 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.
  • The participant is known to be human immunodeficiency virus (HIV) positive.
  • The participant has current or clinical history of Zollinger-Ellison syndrome or other hypersecretory condition.
  • The participant 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.
  • The participant had an acute upper gastrointestinal hemorrhage within 4 weeks prior to endoscopy.
  • The participant has donated or lost ≥300 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.
  • The participant has a known history of alcohol abuse or illegal drug use within the past 12 months prior to the first dose of study drug.
  • The participant has any Screening Visit 1 abnormal laboratory value that suggests a clinically significant underlying disease or condition that may prevent the participant from entering the study; or the participant has: creatinine >1.5 mg/dL, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 times the upper limit of normal (×ULN), or total bilirubin >2.0 mg/dL with AST/ALT elevated above the limits of normal values.
  • 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.
  • The participant, participant's Parent(s) or Legal Guardian 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.
  • The participant or participant's Parent(s) or Legal Guardian, in the opinion of the investigator, is unlikely to comply with the protocol requirements or is unsuitable for any other reason.
  • The participant has participated in another clinical study and/or has received any investigational compound within 30 days prior to Screening.

Trial locations and contacts

60 sites in 8 countries.

60 sites in 8 countries

United States32 sites

  • Study site

    Anaheim, California

  • Study site

    Boston, Massachusetts

  • Study site

    Brooklyn, New York

  • Study site

    Centennial, Colorado

  • Study site

    Chicago, Illinois

  • Study site

    Fairfax, Virginia

  • Study site

    Flint, Michigan

  • Study site

    Fort Worth, Texas

  • Study site

    Greenville, South Carolina

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Indianapolis, Indiana

  • Study site

    Jackson, Mississippi

  • Study site

    Kansas City, Missouri

  • Study site

    Kingsport, Tennessee

  • Study site

    Laredo, Texas

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Mays Landing, New Jersey

  • Study site

    Mobile, Alabama

  • Study site

    Norfolk, Virginia

  • Study site

    Ogden, Utah

  • Study site

    Park Ridge, Illinois

  • Study site

    Phoenix, Arizona

  • Study site

    Plymouth, Minnesota

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Francsco, California

  • Study site

    Thornton, Colorado

  • Study site

    Toledo, Ohio

  • Study site

    Tucson, Arizona

  • Study site

    Youngstown, Ohio

Other trials in United States

Poland7 sites

  • Study site

    Bydgoszcz

  • Study site

    Krakow

  • Study site

    Rzeszów

  • Study site

    Szczecin

  • Study site

    Torun

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Hungary5 sites

  • Study site

    Debrecen

  • Study site

    Győr

  • Study site

    Miskolc

  • Study site

    Nyíregyháza

  • Study site

    Pécs

Other trials in Hungary

Portugal5 sites

  • Study site

    Amadora

  • Study site

    Braga

  • Study site

    Coimbra

  • Study site

    Lisbon

  • Study site

    Porto

Other trials in Portugal

Brazil4 sites

  • Study site

    Passo Fundo, Rio Grande do Sul

  • Study site

    Porto Alegre, Rio Grande do Sul

  • Study site

    Santo André, São Paulo

  • Study site

    São José do Rio Preto, São Paulo

Other trials in Brazil

Italy3 sites

  • Study site

    Bari, Bari

  • Study site

    Messina, Messina

  • Study site

    Roma, Roma

Other trials in Italy

Mexico3 sites

  • Study site

    Culiacán, Sinaloa

  • Study site

    Mexico City, Mexico City

  • Study site

    Monterrey, Nuevo León

Other trials in Mexico

Belgium1 site

  • Study site

    Brussels

Other trials in Belgium

About this study

Official title: A Phase 2 Multicenter, 36-Week Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn, in Adolescent Subjects Aged 12 to 17 Years

The purpose of this study is to assess the safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules in adolescents with erosive esophagitis (EE) and for maintenance of healed EE and relief of heartburn.

Read the detailed description

The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to treat adolescents who have erosive esophagitis and heartburn and maintenance of healing of EE.

The study planned to enroll approximately 60 patients.

The study consisted of 3 periods:

  1. Screening ((21 [+5] days)
  2. Treatment (8 weeks for healing, 16 weeks for maintenance),
  3. Post-Treatment Follow-up (up to 3 months).

During screening, participants used an electronic diary (eDiary) daily to document the presence of daytime and nighttime heartburn symptoms and the degree to which heartburn hurt (hereinafter referred to as severity), and to record their use of rescue medication (antacid).

During the first 8 week treatment period, all participants received dexlansoprazole 60 mg, once daily (QD). At the Week 8 visit, participants underwent endoscopy to assess healing of EE. Participants whose EE had not healed were discontinued from the study.

Participants whose EE had healed were 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 30 mg QD
  • Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient

All participants were asked to take one tablet each morning without regard to food throughout the study. Throughout both phases of the Treatment Period, all participants continued to use the eDiary to document the presence or absence and severity of daytime and nighttime heartburn symptoms and the use of rescue medication.

This multi-center trial was conducted worldwide. The overall time to participate in this study was 39 weeks. Participants made multiple visits to the clinic, and were contacted by telephone during the study

Being tested
Dexlansoprazole, Placebo
Keywords
Drug therapy
Medical subject headings
Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexlansoprazoleDrug

    Also called Dexilant

    Dexlansoprazole capsules

  • DexlansoprazoleDrug

    Also called Dexilant

    Dexlansoprazole capsules

  • PlaceboDrug

    Dexlansoprazole placebo-matching capsules

Study groups in NCT01642615
Study groupRoleWhat they receive
Healing Phase: Dexlansoprazole 60 mgExperimentalDexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
Receives: Drug: Dexlansoprazole
Maintenance Phase: Dexlansoprazole 30 mgExperimentalParticipants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
Receives: Drug: Dexlansoprazole
Maintenance Phase: PlaceboExperimentalParticipants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period

    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose.

    Measured: 8 weeks

  2. Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period

    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose.

    Measured: From Week 8 to Week 24

Secondary outcomes (4)

  1. Percentage of Participants With Healing of Erosive Esophagitis (EE) by Week 8

    Healing of EE was assessed by endoscopy.

    Measured: 8 weeks

  2. Percentage of Participants Who Maintain Healing of EE From Week 8 to Week 24

    Percentage of participants who maintain healing of EE from Week 8 to Week 24 among the patients who were healed at Week 8 as assessed by endoscopy.

    Measured: From Week 8 to Week 24

  3. Percent of Days With Neither Daytime Nor Nighttime Heartburn Over the First 8 Weeks of Treatment

    Percent of days with neither daytime nor nighttime heartburn over the first 8 weeks of treatment as assessed by electronic daily diary. The percent of days with neither daytime or nighttime heartburn = (total number of days that are heartburn free)/(total number of days for which either a daytime or nighttime result is marked) x 100%.

    Measured: 8 weeks

  4. Percent of Days With Neither Daytime Nor Nighttime Heartburn Over Weeks 8 to 24

    The percent of days with neither daytime nor nighttime heartburn over Weeks 8 to 24 as assessed by electronic daily diary among the participants who were healed at Week 8. The percent of days with neither daytime or nighttime heartburn = (total number of days that are heartburn free)/(total number of days for which either a daytime or nighttime result is marked) x 100%.

    Measured: Weeks 8 to 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

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
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01642615
Sponsor's protocol ID
TAK-390MR_207
Other IDs
U1111-1128-6117, 2012-001681-15
Status last verified
May 2015
First submitted
12 Jul 2012
Last updated
27 May 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexlansoprazole in people with Gastroesophageal Reflux Disease and Erosive Esophagitis, run by Takeda at 60 sites in 8 countries.

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 26 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: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Poland, Hungary, Portugal, Brazil and 3 more countries. 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 27 May 2015). 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 Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01642615.

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 27 May 2015.

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