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
Primary Purpose
Gastroesophageal Reflux Disease, Erosive Esophagitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dexlansoprazole
Dexlansoprazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring Drug therapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Healing Phase: Dexlansoprazole 60 mg
Maintenance Phase: Dexlansoprazole 30 mg
Maintenance Phase: Placebo
Arm Description
Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
Participants 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.
Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Percentage of Participants With Healing of Erosive Esophagitis (EE) by Week 8
Healing of EE was assessed by endoscopy.
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.
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%.
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%.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01642615
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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:
Screening ((21 [+5] days)
Treatment (8 weeks for healing, 16 weeks for maintenance),
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Erosive Esophagitis
Keywords
Drug therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healing Phase: Dexlansoprazole 60 mg
Arm Type
Experimental
Arm Description
Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
Arm Title
Maintenance Phase: Dexlansoprazole 30 mg
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Maintenance Phase: Placebo
Arm Type
Experimental
Arm Description
Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Dexlansoprazole
Other Intervention Name(s)
Dexilant
Intervention Description
Dexlansoprazole capsules
Intervention Type
Drug
Intervention Name(s)
Dexlansoprazole
Other Intervention Name(s)
Dexilant
Intervention Description
Dexlansoprazole capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dexlansoprazole placebo-matching capsules
Primary Outcome Measure Information:
Title
Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period
Description
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.
Time Frame
8 weeks
Title
Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period
Description
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.
Time Frame
From Week 8 to Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants With Healing of Erosive Esophagitis (EE) by Week 8
Description
Healing of EE was assessed by endoscopy.
Time Frame
8 weeks
Title
Percentage of Participants Who Maintain Healing of EE From Week 8 to Week 24
Description
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.
Time Frame
From Week 8 to Week 24
Title
Percent of Days With Neither Daytime Nor Nighttime Heartburn Over the First 8 Weeks of Treatment
Description
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%.
Time Frame
8 weeks
Title
Percent of Days With Neither Daytime Nor Nighttime Heartburn Over Weeks 8 to 24
Description
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%.
Time Frame
Weeks 8 to 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director, Clinical Science
Organizational Affiliation
Takeda Global Research and Development Center, Inc.
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
Country
United States
City
Mobile
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Anaheim
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
San Francsco
State/Province
California
Country
United States
City
Centennial
State/Province
Colorado
Country
United States
City
Thornton
State/Province
Colorado
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Park Ridge
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Flint
State/Province
Michigan
Country
United States
City
Plymouth
State/Province
Minnesota
Country
United States
City
Jackson
State/Province
Mississippi
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
Mays Landing
State/Province
New Jersey
Country
United States
City
Brooklyn
State/Province
New York
Country
United States
City
Toledo
State/Province
Ohio
Country
United States
City
Youngstown
State/Province
Ohio
Country
United States
City
Greenville
State/Province
South Carolina
Country
United States
City
Kingsport
State/Province
Tennessee
Country
United States
City
Ft. Worth
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Laredo
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Ogden
State/Province
Utah
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Fairfax
State/Province
Virginia
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Bruxelles
Country
Belgium
City
Passo Fundo
State/Province
Rio Grande do Sul
Country
Brazil
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
City
Santo Andre
State/Province
Sao Paulo
Country
Brazil
City
Santo André
State/Province
Sao Paulo
Country
Brazil
City
São José do Rio Preto
State/Province
Sao Paulo
Country
Brazil
City
Debrecen
Country
Hungary
City
Györ
Country
Hungary
City
Miskolc
Country
Hungary
City
Nyiregyhaza
Country
Hungary
City
Pecs
Country
Hungary
City
Bari
Country
Italy
City
Messina
Country
Italy
City
Roma
Country
Italy
City
Mexico
State/Province
Distrito Federal
Country
Mexico
City
Monterrey
State/Province
Nuevo León
Country
Mexico
City
Culiacan
State/Province
Sinaloa
Country
Mexico
City
Bydgoszcz
Country
Poland
City
Krakow
Country
Poland
City
Rzeszow
Country
Poland
City
Szczecin
Country
Poland
City
Torun
Country
Poland
City
Warszawa
Country
Poland
City
Wroclaw
Country
Poland
City
Amadora
Country
Portugal
City
Braga
Country
Portugal
City
Coimbra
Country
Portugal
City
Lisboa
Country
Portugal
City
Porto
Country
Portugal
12. IPD Sharing Statement
Learn more about this trial
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
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