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Gastroesophageal Reflux DiseasePhase 2NCT01642602

Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules in Treating Symptomatic Non-Erosive Gastroesophageal Reflux Disease in Adolescents

A Phase 2 study testing Dexlansoprazole in people with Gastroesophageal Reflux Disease, run by Takeda at 64 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 was to assess the safety and effectiveness of once daily oral administration of dexlansoprazole delayed-release capsules in adolescent participants with symptomatic non-erosive gastroesophageal reflux disease (GERD). Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Gastroesophageal Reflux Disease
What is being tested?
Dexlansoprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
64 sitesin 8 countries
Study dates
Jul 2012to Jan 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 GERD for at least 3 months prior to Screening (signed informed consent 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.
  • The participant has non-erosive GERD with no evidence of definite endoscopic esophageal mucosal breaks as described in the Los Angeles Classification of Esophagitis at 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, or 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 a 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 the participant tests positive for tTG antibody.
  • The participant has active gastric or duodenal ulcers within 4 weeks prior to Day -1.
Show all 25Show 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 PPI within 1 week (7 days) prior to the Screening Visit.
  • 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 positive for human immunodeficiency virus (HIV).
  • 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

64 sites in 8 countries.

64 sites in 8 countries

United States35 sites

  • Study site

    Anaheim, California

  • Study site

    Atlanta, Georgia

  • 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

    Huntsville, North Carolina

  • 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

    Miami, Florida

  • 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

Hungary6 sites

  • Study site

    Debrecen

  • Study site

    Győr

  • Study site

    Miskolc

  • Study site

    Nyíregyháza

  • Study site

    Pécs

  • Study site

    Veszprém

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 Open-Label, Multicenter, 4-Week Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Relief of Heartburn, in Adolescent Subjects Aged 12 to 17 Years With Symptomatic Non-Erosive Gastroesophageal Reflux Disease

The purpose of this study was to assess the safety and effectiveness of once daily oral administration of dexlansoprazole delayed-release capsules in adolescent participants with symptomatic non-erosive gastroesophageal reflux disease (GERD).

Being tested
Dexlansoprazole
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, TAK-390MR

    Dexlansoprazole delayed-release capsules.

Study groups in NCT01642602
Study groupRoleWhat they receive
Dexlansoprazole 30 mgExperimentalDexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
Receives: Drug: Dexlansoprazole

What is being measured

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

  1. Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants While Receiving Dexlansoprazole During the 4 Week Treatment Period

    A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that started or worsened on or after Study Day 1 (defined as first dose day), and no more than 30 days after the last dose of study drug.

    Measured: 4 weeks

Secondary outcomes (1)

  1. The Percentage of Days With Neither Daytime Nor Nighttime Heartburn Over the 4 Weeks of Treatment

    Participants documented the presence or absence and the degree to which daytime and nighttime heartburn symptoms hurt daily in an electronic daily diary.

    Measured: 4 weeks

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 completionJan 2014
  4. Study completionJan 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01642602
Sponsor's protocol ID
TAK-390MR_206
Other IDs
U1111-1128-5977, 2012-001680-72
Status last verified
Jul 2014
First submitted
12 Jul 2012
Last updated
6 Aug 2014
Data monitoring committee
No

Publications

  • Gold BD, Pilmer B, Kierkus J, Hunt B, Perez MC, Gremse D. Dexlansoprazole for Heartburn Relief in Adolescents with Symptomatic, Nonerosive Gastro-esophageal Reflux Disease. Dig Dis Sci. 2017 Nov;62(11):3059-3068. doi: 10.1007/s10620-017-4743-3. Epub 2017 Sep 15.

    PubMed 28916953

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexlansoprazole in people with Gastroesophageal Reflux Disease, run by Takeda at 64 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 25 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 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 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 6 Aug 2014). 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?

Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants While Receiving Dexlansoprazole During the 4 Week Treatment Period (time frame: 4 weeks). 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 NCT01642602, which also lists 1 linked publication.

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 6 Aug 2014.

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