Trial Outcomes & Findings for 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 (NCT NCT01642615)

Last Updated: 2015-05-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

8 weeks

Results posted on

2015-05-27

Participant Flow

Participants took part in the study at 18 investigative sites in Mexico, Poland, Portugal and the United States from 22 June 2012 (first participant to sign the informed consent) to 10 November 2014.

Sixty three adolescents with a diagnosis of erosive esophagitis (EE) were enrolled in the dexlansoprazole delayed release 60 mg capsules open label phase. One participant was not treated. Participants with healed EE were randomized into one of 2 treatment groups: dexlansoprazole delayed release 30 mg capsules or placebo in the maintenance phase.

Participant milestones

Participant milestones
Measure	Healing Phase: Dexlansoprazole 60 mg Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.	Maintenance Phase: Dexlansoprazole 30 mg 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.	Maintenance Phase: Placebo Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
Open Label Maintenance Phase STARTED	63	0	0
Open Label Maintenance Phase Safety Analysis Set	62	0	0
Open Label Maintenance Phase COMPLETED	58	0	0
Open Label Maintenance Phase NOT COMPLETED	5	0	0
Double Blind Maintenance Phase STARTED	0	25	26
Double Blind Maintenance Phase COMPLETED	0	18	20
Double Blind Maintenance Phase NOT COMPLETED	0	7	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Healing Phase: Dexlansoprazole 60 mg Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.	Maintenance Phase: Dexlansoprazole 30 mg 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.	Maintenance Phase: Placebo Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
Open Label Maintenance Phase Pretreatment Event/Adverse Event	1	0	0
Open Label Maintenance Phase Major Protocol Deviation	1	0	0
Open Label Maintenance Phase Lost to Follow-up	1	0	0
Open Label Maintenance Phase Voluntary Withdrawal	1	0	0
Open Label Maintenance Phase Did not receive treatment	1	0	0
Double Blind Maintenance Phase Lack of Efficacy	0	1	3
Double Blind Maintenance Phase Voluntary Withdrawal	0	5	2
Double Blind Maintenance Phase Pretreatment Event/Adverse Event	0	1	0
Double Blind Maintenance Phase Requires Treatment with Another Drug	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=62 Participants Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks in the Open Label Healing Phase. Participants with healing of EE were eligible to participate in the Maintenance Phase.
Age, Continuous	14.8 years STANDARD_DEVIATION 1.64 • n=5 Participants
Age, Customized 12 to 14 years	24 participants n=5 Participants
Age, Customized 15 to 17 years	38 participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	16 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	6 participants n=5 Participants
Race/Ethnicity, Customized Not Collected outside the United States	40 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 participants n=5 Participants
Race/Ethnicity, Customized White	61 participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants
Region of Enrollment Portugal	4 participants n=5 Participants
Region of Enrollment Poland	34 participants n=5 Participants
Region of Enrollment Mexico	2 participants n=5 Participants
Height	165.5 cm STANDARD_DEVIATION 9.68 • n=5 Participants
Weight	61.86 kg STANDARD_DEVIATION 17.060 • n=5 Participants
Body Mass Index (BMI)	22.34 kg/m^2 STANDARD_DEVIATION 5.086 • n=5 Participants
Smoking Classification Never smoked	61 participants n=5 Participants
Smoking Classification Current smoker	1 participants n=5 Participants
Smoking Classification Ex-smoker	0 participants n=5 Participants
Helicobacter pylori (H. pylori) Status Positive	0 participants n=5 Participants
Helicobacter pylori (H. pylori) Status Negative	61 participants n=5 Participants
Helicobacter pylori (H. pylori) Status Unknown	1 participants n=5 Participants
Erosive Esophagitis Present Yes	62 participants n=5 Participants
Erosive Esophagitis Present No	0 participants n=5 Participants
Baseline EE Grade (LA Classification) A	34 participants n=5 Participants
Baseline EE Grade (LA Classification) B	26 participants n=5 Participants
Baseline EE Grade (LA Classification) C	1 participants n=5 Participants
Baseline EE Grade (LA Classification) D	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Safety analysis set includes all enrolled participants who received at least one dose of open-label study drug in the first 8 weeks.

Outcome measures

Outcome measures
Measure	Healing Phase: Dexlansoprazole 60 mg n=62 Participants Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.	Maintenance Phase: Placebo Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period Diarrhoea	6.5 percentage of participants	—
Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period Nasopharyngitis	6.5 percentage of participants	—
Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period Headache	12.9 percentage of participants	—
Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period Oropharyngeal pain	8.1 percentage of participants	—

PRIMARY outcome

Timeframe: From Week 8 to Week 24

Population: Safety Analysis Set included all participants with healed EE at Week 8 who were randomized and received at least one dose of open-label study drug in Weeks 8 to 24.

Outcome measures

Outcome measures
Measure	Healing Phase: Dexlansoprazole 60 mg n=25 Participants Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.	Maintenance Phase: Placebo n=26 Participants Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period Pharyngitis	12.0 percentage of participants	0.0 percentage of participants
Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period Abdominal pain	12.0 percentage of participants	11.5 percentage of participants
Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period Abdominal pain upper	4.0 percentage of participants	7.7 percentage of participants
Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period Erosive oesophagitis	4.0 percentage of participants	7.7 percentage of participants
Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period Diarrhoea	0.0 percentage of participants	7.7 percentage of participants
Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period Pyrexia	0.0 percentage of participants	7.7 percentage of participants
Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period Nasopharyngitis	12.0 percentage of participants	15.4 percentage of participants
Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period Sinusitis	12.0 percentage of participants	0.0 percentage of participants
Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period Upper respiratory tract infection	8.0 percentage of participants	0.0 percentage of participants
Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period Bronchitis	8.0 percentage of participants	3.8 percentage of participants
Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period Headache	24.0 percentage of participants	15.4 percentage of participants
Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period Insomnia	8.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants from the Full Analysis Set, all enrolled participants who received at least one dose of open-label study drug in the first 8 weeks, with data available for analysis.

Healing of EE was assessed by endoscopy.

Outcome measures

Outcome measures
Measure	Healing Phase: Dexlansoprazole 60 mg n=58 Participants Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.	Maintenance Phase: Placebo Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
Percentage of Participants With Healing of Erosive Esophagitis (EE) by Week 8	87.9 percentage of participants Interval 76.7 to 95.0	—

SECONDARY outcome

Timeframe: From Week 8 to Week 24

Population: Participants from the Full Analysis Set, all participants with healed EE at Week 8 who were randomized and received at least one dose of open-label study drug in Weeks 8 to 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.

Outcome measures

Outcome measures
Measure	Healing Phase: Dexlansoprazole 60 mg n=22 Participants Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.	Maintenance Phase: Placebo n=24 Participants Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
Percentage of Participants Who Maintain Healing of EE From Week 8 to Week 24	81.8 percentage of participants Interval 59.7 to 94.8	58.3 percentage of participants Interval 36.6 to 77.9

SECONDARY outcome

Timeframe: 8 weeks

Population: Participants from the Full Analysis Set, all enrolled participants who received at least one dose of open-label study drug in the first 8 weeks, with data available for analysis.

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%.

Outcome measures

Outcome measures
Measure	Healing Phase: Dexlansoprazole 60 mg n=62 Participants Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.	Maintenance Phase: Placebo Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
Percent of Days With Neither Daytime Nor Nighttime Heartburn Over the First 8 Weeks of Treatment	59.6 percent of days Standard Deviation 30.46	—

SECONDARY outcome

Timeframe: Weeks 8 to 24

Population: Participants from the Full Analysis Set, all participants with healed EE at Week 8 who were randomized and received at least one dose of open-label study drug in 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%.

Outcome measures

Outcome measures
Measure	Healing Phase: Dexlansoprazole 60 mg n=24 Participants Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.	Maintenance Phase: Placebo n=26 Participants Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
Percent of Days With Neither Daytime Nor Nighttime Heartburn Over Weeks 8 to 24	76.7 percent of days Standard Deviation 29.82	68.9 percent of days Standard Deviation 26.04

Adverse Events

Healing Phase: Dexlansoprazole 60 mg

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Maintenance Phase: Dexlansoprazole 30 mg

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Maintenance Phase: Placebo

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Healing Phase: Dexlansoprazole 60 mg n=62 participants at risk Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.	Maintenance Phase: Dexlansoprazole 30 mg n=25 participants at risk 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.	Maintenance Phase: Placebo n=26 participants at risk Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
Psychiatric disorders Substance abuse	1.6% 1/62 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/62 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.0% 1/25 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations H1N1 influenza	0.00% 0/62 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.8% 1/26 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Convulsion	0.00% 0/62 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.0% 1/25 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Other adverse events
Measure	Healing Phase: Dexlansoprazole 60 mg n=62 participants at risk Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.	Maintenance Phase: Dexlansoprazole 30 mg n=25 participants at risk 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.	Maintenance Phase: Placebo n=26 participants at risk Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
Nervous system disorders Headache	12.9% 8/62 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	24.0% 6/25 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	15.4% 4/26 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.1% 5/62 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.0% 1/25 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.8% 1/26 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Diarrhoea	6.5% 4/62 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 2/26 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Nasopharyngitis	6.5% 4/62 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.0% 3/25 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	15.4% 4/26 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain	4.8% 3/62 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.0% 3/25 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.5% 3/26 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal pain upper	1.6% 1/62 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.0% 1/25 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 2/26 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Bronchitis	1.6% 1/62 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.0% 2/25 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.8% 1/26 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Pharyngitis	4.8% 3/62 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.0% 3/25 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Sinusitis	1.6% 1/62 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.0% 3/25 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/62 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.0% 1/25 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 2/26 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Insomnia	1.6% 1/62 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.0% 2/25 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Pyrexia	0.00% 0/62 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/25 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 2/26 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Upper respiratory tract infection	3.2% 2/62 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.0% 2/25 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/26 • Up to 24 Weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER