A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old

Last updated: September 25, 2024
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

2

Condition

Esophageal Disorders

Heartburn (Pediatric)

Heartburn

Treatment

Dexlansoprazole

Clinical Study ID

NCT02615184
TAK-390MR_205
U1111-1166-8811
2014-004507-73
2022-501350-11
  • Ages 2-11
  • All Genders

Study Summary

Gastroesophageal reflux disease (GERD) is caused by food or acid coming up from the stomach into the esophagus, repeatedly. The esophagus is the tube that carries food and liquids from the mouth to the stomach. The body uses stomach acid to break down food, but when acid rises up into the esophagus it can hurt or damage it. People with GERD often feel food coming back up into the throat and mouth and have a burning feeling in their stomach, chest, or throat, called heartburn. Other symptoms of GERD include pain in the stomach or throat, difficulty eating, and throwing up. Sometimes GERD damages the lining of the esophagus, creating breaks. This is called erosive esophagitis (EE).

Dexlansoprazole is a type of medicine that helps lower the amount of acid made in the stomach. It has been shown to heal EE and maintain (keep) healing of EE in adults and teenagers. This study is being done to find out if dexlansoprazole can also heal EE and maintain the healing of EE in children.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. In the opinion of the investigator, the participant (as age appropriate) and/orparent(s) or legal guardian are capable of understanding and complying with protocolrequirements.

  2. Prior to any study-specific procedures being performed, the appropriate screeninginformed consent and the assent forms (as applicable) must be signed and dated byparent(s) or legal guardian and by the participant respectively, if appropriate.

  3. Has a medical history of symptoms of GERD for at least 3 months prior to Screening.

  4. Has met the eDiary qualification criteria as assessed by the PGSDD, defined ashurting or burning in the stomach, chest, or throat on at least 3 of any 7consecutive days during the Screening Period. (Note: If an endoscopy performedwithin 1 week of signing screening informed consent and assent [as applicable] isused to confirm diagnosis of EE, the participant does not need to meet thiscriterion).

  5. Has endoscopic evidence of EE with Los Angeles (LA) Grade A to D based on thescreening endoscopy performed either during the Screening Period or within 1 weekprior to signing screening informed consent and assent (as applicable). An endoscopythat was performed within 1 week prior to signing screening informed consent andassent, as applicable, is an acceptable replacement for the Screening endoscopy ifEE is documented by LA classification scale criterion previously described,protocol-required biopsies were collected and endoscopic pictures were obtained.

  6. Is male or female and age 2 to 11 years, inclusive, at the time of screeninginformed consent.

Exclusion

Exclusion Criteria:

  1. Has evidence of cardiovascular, pulmonary, central nervous system, hepatic,hematopoietic, renal, or metabolic disorder, severe allergy, asthma, or allergicskin rash that suggests any uncontrolled, clinically significant underlying diseaseor condition (other than the disease being studied), which may impact the ability ofthe participant to participate or potentially confound the study results.

  2. Has a coexisting disease affecting the esophagus (eg, esophageal varices,scleroderma, viral or fungal infection, or esophageal stricture), history ofradiation therapy or cryotherapy to the esophagus, caustic or physiochemical traumasuch as sclerotherapy to the esophagus.

  3. Has any findings in his/her medical history, physical examination, or safetyclinical laboratory tests giving reasonable suspicion of underlying disease thatmight interfere with the conduct of the trial.

  4. Has a history of hypersensitivity or allergies to dexlansoprazole or any componentof dexlansoprazole capsules or any PPI (including lansoprazole, omeprazole,rabeprazole, pantoprazole, or esomeprazole) or antacids.

  5. Is required to take excluded medications or it is anticipated that the participantwill require treatment with at least 1 of the disallowed concomitant medicationsduring the study evaluation period.

  6. Has a condition that may require inpatient surgery during the course of the study.

  7. Has a known history of Barrett's with dysplastic changes in the esophagus.

  8. Has a known history of eosinophilic esophagitis (EoE) or histologic findingssuggestive of EoE (≥15 eosinophils per high-powered field [HPF]).

  9. Has history of celiac disease, tests positive for tissue transglutaminase (tTG)antibody, or has confirmed disease by histology.

  10. Has history of inflammatory bowel disease, or irritable bowel syndrome.

  11. Has active gastric or duodenal ulcers within 4 weeks prior to Day -1. If present >4weeks prior to Day -1, ulcers must not be present upon screening endoscopy.

  12. Requires dilatation of esophageal strictures and/or strictures preventing passage ofthe endoscope during the Screening endoscopy. Schatzki's ring (a ring of mucosaltissue near the lower esophageal sphincter) is acceptable.

  13. A female participant who has reached menarche by Day -1.

  14. Is known to be positive for the human immunodeficiency virus (HIV).

  15. Has current or clinical history of Zollinger-Ellison syndrome or otherhypersecretory condition.

  16. Has a history of gastric, duodenal, or esophageal surgery except simple oversew ofan ulcer. A history of gastric tube and/or percutaneous endoscopic gastrostomy (PEG)placement is allowed.

  17. Had an acute upper gastrointestinal hemorrhage within 4 weeks prior to endoscopy.

  18. Has donated or lost >10% of the total blood volume, undergone plasmapheresis, or hashad a transfusion of any blood product within 90 days prior to the first dose ofstudy drug.

  19. Has a known history of alcohol abuse or illegal drug use within the past 12 monthsprior to the first dose of study drug.

  20. Has any screening abnormal laboratory value that suggests a clinically significantunderlying disease or condition that may prevent the participant from entering thestudy; or the participant has: creatinine >1.5 milligrams per deciliter (mg/dL),alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 times theupper limit of normal (×ULN), or total bilirubin >2.0 mg/dL with AST/ALT elevatedabove the limits of normal values.

  21. Is an immediate family member, study site employee, or is in a dependentrelationship with a study site employee who is involved in the conduct of this studyor may consent and assent under duress. Students of the institution/researchfacility who are under the supervision of, or in a subordinate role to, theinvestigator are also ineligible.

  22. The participant, in the opinion of the investigator, is unlikely to comply with theprotocol or is unsuitable for any other reason.

  23. Has participated in another clinical study (not including screening for StudyTAK-390MR_204 [NCT02616302]) and/or has received any investigational compound within 30 days prior to Screening.

  24. Tests positive for Helicobacter pylori.

Study Design

Total Participants: 76
Treatment Group(s): 1
Primary Treatment: Dexlansoprazole
Phase: 2
Study Start date:
May 23, 2023
Estimated Completion Date:
October 31, 2027

Study Description

The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to heal EE and maintain healing of EE in pediatric participants aged 2 to 11 years. This study will look at the healing of EE followed by maintained healing of EE in children who take dexlansoprazole.

The study will be conducted in two periods; a Healing of EE Period and a Maintenance of Healed EE Period. Approximately 76 patients will be enrolled in this study. Participants will be randomly assigned (by chance, like flipping a coin) to receive dexlansoprazole 60 milligrams (mg) or dexlansoprazole 30 mg for 8 weeks during the Healing of EE Period. Following Week 8, participants will enter the Maintenance of Healed EE Period and will receive half their healing dose of dexlansoprazole, (i.e., either 30 mg, dexlansoprazole 15 mg).

All participants will be asked to take one capsule at the same time each day throughout the study. All participants will be asked to record any time they have heartburn symptoms in a diary.

Participants who complete the 16 weeks of the Maintenance of Healed EE Period (Week 24) and have maintained healing of EE as confirmed by endoscopy, will enter a Post-Treatment Follow up Period for up to 3 months after the last dose of study drug. During this period participants will continue to complete the symptom questionnaires daily in the eDiaries and return for a clinic visit each month. Participants who require an invasive procedure or treatment with a proton pump inhibitor (PPI) or histamine 2-receptor antagonist (H2RA) for gastroesophageal reflux disease (GERD)/EE will be discontinued from the Post-Treatment Follow-up Period and a Final Study Visit will be performed.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 10 months. Participants will make multiple visits to the clinic including a final visit 3 months after last dose of study drug for a follow-up assessment.

Connect with a study center

  • Universitair Ziekenhuis Brussel

    Bruxelles, 1090
    Belgium

    Site Not Available

  • CHC - Cliniques de l'Esperance

    Montegnee, 4420
    Belgium

    Site Not Available

  • Hospital Sao Vicente de Paulo

    Passo Fundo, Rio Grande Do Sul 99010-080
    Brazil

    Site Not Available

  • Hospital Israelita Albert Einstein

    Sao Paulo, 05651-901
    Brazil

    Site Not Available

  • Women and Children's Health Research Institute

    Edmonton, Alberta T6G 1C9
    Canada

    Site Not Available

  • London Health Sciences Centre (LHSC) - Children's Hospital

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • Hospital Universitario San Ignacio

    Bogota, 110231
    Colombia

    Site Not Available

  • Centro Medico Imbanaco de Cali S.A

    Cali, 760042
    Colombia

    Site Not Available

  • Fundacion Valle del Lili

    Cali, 760032
    Colombia

    Site Not Available

  • HaEmek Medical Center

    Afula, 18341
    Israel

    Site Not Available

  • Soroka University Medical Center

    Beer Sheva, 8410101
    Israel

    Site Not Available

  • Assaf Harofeh M.C

    Beer Yaakov, 70300
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa, 3109601
    Israel

    Site Not Available

  • Hadassah University Hospital-Mt. Scopus

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Site Not Available

  • The Baruch Padeh MC, Poriya

    Tiberias, 1520800
    Israel

    Site Not Available

  • Azienda Ospedaliera Universitaria "Federico II"

    Napoli, 80131
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambino Gesu

    Roma, 00165
    Italy

    Site Not Available

  • Hospital of Lithuanian University of Health Sciences Kauno Klinikos

    Kaunas, LT-50161
    Lithuania

    Active - Recruiting

  • Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos, Public Institution

    Vilnius, LT-08661
    Lithuania

    Active - Recruiting

  • Boca Clinical Trials Mexico SC

    Colonia Las Americas, Distrito Federal 1120
    Mexico

    Site Not Available

  • Mexico Centre for Clinical Research S.A de C.V

    Mexico, Distrito Federal 3100
    Mexico

    Site Not Available

  • Clinical Research Institute S.C.

    Tlalnepantla, Estado De Mexico 54055
    Mexico

    Active - Recruiting

  • Centro de Investigacion Clinica Chapultepec S.A. de C.V.

    Morelia, Michoacan 58260
    Mexico

    Site Not Available

  • Inspirepharma S. de R.L. de C.V.

    Monterrey, Nuevo Leon 64660
    Mexico

    Site Not Available

  • El Cielo Medical Center

    Puebla, 72160
    Mexico

    Active - Recruiting

  • SMIQ S. de R.L. de C.V.

    Queretaro, 76070
    Mexico

    Active - Recruiting

  • Sociedad de Metabolismo y Corazon, S.C.

    Veracruz, 91910
    Mexico

    Site Not Available

  • In Vivo Osrodek Badan Klinicznych

    Bydgoszcz, Kuyavia 85-048
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow, Malopolskie 30-663
    Poland

    Site Not Available

  • Instytut "Pomnik - Centrum Zdrowia Dziecka"

    Warszawa, Masovia 04-730
    Poland

    Site Not Available

  • Gabinet Lekarski Bartosz Korczowski

    Rzeszow, Podkarpackie 35-302
    Poland

    Active - Recruiting

  • Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu

    Worclaw, 50-369
    Poland

    Site Not Available

  • Hospital de Braga

    Braga, 4710-243
    Portugal

    Site Not Available

  • Hospital Pediatrico de Coimbra

    Coimbra, 3000-602
    Portugal

    Site Not Available

  • Centro Hospitalar de Lisboa Central, E.P.E. - Hospital Dona Estefania- Servico de Gastroenterologia

    Lisboa, 1169-045
    Portugal

    Site Not Available

  • Centro Hospitalar de Sao Joao, E.P.E.

    Porto, 4200-319
    Portugal

    Site Not Available

  • University of South Alabama

    Mobile, Alabama 36604
    United States

    Active - Recruiting

  • Arizona Center for Clinical Trials LLC

    Phoenix, Arizona 85003
    United States

    Site Not Available

  • University of Arizona

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94158
    United States

    Site Not Available

  • D&H National Research Centers

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Children's Center for Digestive Health Care, LLC

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Willis-Knighton Physician Network

    Shreveport, Louisiana 71101
    United States

    Site Not Available

  • Gastrointestinal Associates, PA

    Flowood, Mississippi 39232
    United States

    Active - Recruiting

  • University of Mississippi

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Children's Mercy Hospital

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Pediatric Pharmacology Research Center

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Measurable Outcome Research

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • GI for Kids

    Knoxville, Tennessee 37922
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Cook Children's Medical Center

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Texas Children's Hospital -Research Resource Office

    Houston, Texas 77030
    United States

    Site Not Available

  • Envision Clinical Research, LLC

    Laredo, Texas 78041
    United States

    Active - Recruiting

  • Primary Children's Medical Center

    Salt Lake City, Utah 84108
    United States

    Site Not Available

  • The Children's Hospital of The King's Daughters

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

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