Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 2, Double Blind Study to Assess Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis (EE) and Maintenance of Healed EE in Pediatric Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02615184
Recruitment Status : Not yet recruiting
First Posted : November 26, 2015
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to assess the safety and effectiveness of treatment with once daily (QD) oral administration of dexlansoprazole 30 or 60 mg for 8 to 12 weeks in pediatric subjects aged 1 to 11 years inclusive, with erosive esophagitis (EE) and to assess the safety and effectiveness of dexlansoprazole 15 or 30 mg compared to placebo in maintenance of healed EE for 16 weeks.

Condition or disease Intervention/treatment Phase
Erosive Esophagitis Drug: Dexlansoprazole Drug: Placebo Phase 2

Detailed Description:

The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to heal erosive esophagitis (EE) and maintain healing of EE in pediatric participants aged 1 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 80 patients will be enrolled in this study. Participants will be randomly assigned (by chance, like flipping a coin) to receive dexlansoprazole 60 mg or dexlansoprazole 30 mg for 8 to 12 weeks during the Healing of EE Period. Participants who have healed EE confirmed by endoscopy at week 8 or 12 will enter the Maintenance of Healed EE Period and will be randomly assigned to receive half their healing dose of dexlansoprazole,( i.e., either 30 mg, dexlansoprazole 15 mg), or placebo (this is a capsule that looks like the study drug but has no active ingredient).

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.

Subjects who complete the 16 weeks of the Maintenance of Healed EE Period (Week 24 or Week 28 as applicable) 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 subjects will continue to complete the symptom questionnaires daily in the eDiaries and return for a clinic visit each month. Subjects 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 40 weeks. 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double Blind, Up to 40 Week, Multicenter Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis (EE) and Maintenance of Healed EE in Pediatric Subjects Aged 1 to 11 Years With EE
Estimated Study Start Date : December 15, 2019
Estimated Primary Completion Date : September 15, 2026
Estimated Study Completion Date : September 15, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healing Period: Dexlansoprazole 60 mg
Dexlansoprazole 60 mg, capsules, orally, once, daily, for 8 to 12 weeks (healing of erosive esophagitis [EE] confirmed by endoscopy).
Drug: Dexlansoprazole
Dexlansoprazole capsules
Other Name: Dexilant

Experimental: Healing Period: Dexlansoprazole 30 mg
Dexlansoprazole 30 mg, capsules, orally, once, daily, for 8 to 12 weeks (healing of EE confirmed by endoscopy).
Drug: Dexlansoprazole
Dexlansoprazole capsules
Other Name: Dexilant

Experimental: Maintenance: Dexlansoprazole 30 mg
Participants in the Healing Period: Dexlansoprazole 60 mg treatment arm with healed EE confirmed by endoscopy will be re-randomized to receive dexlansoprazole 30 mg, capsules, orally, once, daily, for 16 weeks in the Maintenance Period.
Drug: Dexlansoprazole
Dexlansoprazole capsules
Other Name: Dexilant

Experimental: Maintenance: Dexlansoprazole 15 mg
Participants in the Healing Period: Dexlansoprazole 30 mg treatment arm with healed EE confirmed by endoscopy will be re-randomized to receive dexlansoprazole 15 mg, capsules, orally, once, daily, for 16 weeks in the Maintenance Period.
Drug: Dexlansoprazole
Dexlansoprazole capsules
Other Name: Dexilant

Placebo Comparator: Maintenance: Placebo
Participants who are eligible to enter the Maintenance of Healing period as confirmed by endoscopy will be re-randomized to receive placebo-matching capsules, orally, once, daily, for 16 weeks in the Maintenance Period.
Drug: Placebo
Dexlansoprazole placebo-matching capsules




Primary Outcome Measures :
  1. Percentage of Participants with Healing of Erosive Esophagitis (EE) by Week 12 [ Time Frame: Week 12 ]
    Healing of EE will be assessed by endoscopy.

  2. Percentage of Participants who Maintain Healing of EE from Week 12 to Week 28 [ Time Frame: Week 12 to Week 28 ]
    Percentage of participants who maintain healing of EE from Week 12 to Week 28 among the participants who were healed at Week 12 as assessed by endoscopy.


Secondary Outcome Measures :
  1. Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat Over the First 8 or 12 Weeks of Treatment [ Time Frame: Weeks 8 or 12 ]
    Daily electronic diaries (eDiaries) will be completed which contain Pediatric Gastroesophageal Reflux Disease Symptom Daily Diaries (PGSDD) questionnaires that document presence or absence of hurting or burning in the stomach, chest or throat vomiting, regurgitation and trouble eating. Parents or caregivers of participants aged 1 to 8 years will complete the PGSDD (parent) in the eDiary for their child and participants aged 9 to 11 years will complete PGSDD (child) in the eDiary themselves. The eDiaries will be completed on a daily basis reflecting a continuous 24-hour period.

  2. Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat Over Weeks 8 to 24 or Weeks 12 to 28 Among Participants Who were Healed by Week 12 [ Time Frame: Weeks 8 to 24 or Weeks 12 to 28 ]
    Daily electronic diaries (eDiaries) will be completed which contain Pediatric Gastroesophageal Reflux Disease Symptom Daily Diaries (PGSDD) questionnaires that document presence or absence of hurting or burning in the stomach, chest or throat vomiting, regurgitation and trouble eating. Parents or caregivers of participants aged 1 to 8 years will complete the PGSDD (parent) in the eDiary for their child and participants aged 9 to 11 years will complete PGSDD (child) in the eDiary themselves. The eDiaries will be completed on a daily basis reflecting a continuous 24-hour period.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. In the opinion of the investigator, the participant (as age appropriate) and/or parent(s) or legal guardian are capable of understanding and complying with protocol requirements.
  2. Prior to any study-specific procedures being performed, the informed consent and the assent form must be signed and dated by parent(s) or legal guardian and by the participant respectively, if appropriate.
  3. Has a medical history of symptoms of gastroesophageal reflux disease (GERD) for at least 3 months prior to Screening.
  4. Has medical history of at least 1 failed attempted withdrawal of prior proton pump inhibitor (PPI)/acid suppressive therapy with a return of symptoms upon withdrawal.
  5. Has met the electronic diary (eDiary) qualification criteria as assessed by the Pediatric GERD Symptom Daily Diaries (PGSDD), defined as hurting or burning in the stomach, chest, or throat on at least 3 of any 7 consecutive days during the Screening Period. (Note: If an endoscopy performed within 1 week of signing informed consent and assent is used to confirm diagnosis of erosive esophagitis (EE), the participant does not need to meet this criterion).
  6. Has endoscopic evidence of EE with Hetzel-Dent (HD) Grade ≥2 based on the screening endoscopy performed either during the Screening Period or within 1 week prior to signing informed consent and assent (as applicable). An endoscopy that was performed within 1 week prior to signing informed consent and assent, as applicable, is an acceptable replacement for the Screening endoscopy if EE is documented by HD classification scale criterion previously described, protocol-required biopsies were collected and endoscopic pictures were obtained.
  7. Is male or female and age 1 to 11 years inclusive at Screening.

Exclusion Criteria:

  1. Has evidence of cardiovascular, pulmonary, central nervous system, hepatic, hematopoietic, renal, or metabolic disorder, severe allergy, asthma, or allergic skin rash that suggests any uncontrolled, clinically significant 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.
  2. Has a coexisting 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.
  3. Has any findings 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.
  4. 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 antacids.
  5. Is required to take excluded medications or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during 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 endoscopic findings suggestive of EoE (≥15 eosinophils per high-powered field [HPF]).
  9. Has history of celiac disease, confirmed by histology or tests positive for tissue transglutaminase (tTG) antibody.
  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.
  12. 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.
  13. A female participant who has reached menarche.
  14. Is known to be positive for the human immunodeficiency virus (HIV).
  15. Has current or clinical history of Zollinger-Ellison syndrome or other hypersecretory condition.
  16. 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.
  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 has had a transfusion of any blood product within 90 days prior to the first dose of study drug.
  19. Has a known history of alcohol abuse or illegal drug use within the past 12 months prior to the first dose of study drug.
  20. Has any screening 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.
  21. 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.
  22. The participant, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.
  23. Has participated in another clinical study and/or has received any investigational compound within 30 days prior to Screening.
  24. Tests positive for H. pylori. However, participants who are positive and have received therapeutically approved eradication therapy within the past 6 months will be allowed to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615184


Contacts
Layout table for location contacts
Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

  Show 45 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Layout table for investigator information
Study Director: Medical Director Clinical Science Takeda

Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02615184     History of Changes
Other Study ID Numbers: TAK-390MR_205
2014-004507-73 ( EudraCT Number )
U1111-1166-8811 ( Registry Identifier: WHO )
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Dexlansoprazole
Lansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action