Trial Outcomes & Findings for Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules in Treating Symptomatic Non-Erosive Gastroesophageal Reflux Disease in Adolescents (NCT NCT01642602)

Last Updated: 2014-08-06

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

104 participants

Primary outcome timeframe

4 weeks

Results posted on

2014-08-06

Participant Flow

Participants took part in the study at 36 sites in the United States, Belgium, Hungary, Italy, Poland, Portugal, Brazil, and Mexico from 22 June 2012 to 21 January 2014.

Adolescent participants (male or female), aged 12 to 17 years (inclusive) with symptomatic non-erosive gastrointestinal reflux disease were enrolled in 1 group and received dexlansoprazole 30 mg orally once daily for up to 4 weeks.

Participant milestones

Participant milestones
Measure	Dexlansoprazole 30 mg Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
Overall Study STARTED	104
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Dexlansoprazole 30 mg Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
Overall Study Adverse Event	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexlansoprazole 30 mg n=104 Participants Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
Age, Continuous	15.0 years STANDARD_DEVIATION 1.50 • n=5 Participants
Age, Customized 12 to 14 years	34 participants n=5 Participants
Age, Customized 15 to 17 years	70 participants n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	6 participants n=5 Participants
Race/Ethnicity, Customized White	95 participants n=5 Participants
Race/Ethnicity, Customized Multiracial	3 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	19 participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic and Latino	47 participants n=5 Participants
Race/Ethnicity, Customized Not Collected	38 participants n=5 Participants
Weight	61.60 kg STANDARD_DEVIATION 14.393 • n=5 Participants
Height	163.1 cm STANDARD_DEVIATION 7.58 • n=5 Participants
Body Mass Index (BMI)	23.02 kg/m^2 STANDARD_DEVIATION 4.434 • n=5 Participants
Smoking Classification Never Smoked	103 participants n=5 Participants
Smoking Classification Ex-smoker	1 participants n=5 Participants
H pylori Status Positive	14 participants n=5 Participants
H pylori Status Negative	90 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Safety analysis set: All participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Dexlansoprazole 30 mg n=104 Participants Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants While Receiving Dexlansoprazole During the 4 Week Treatment Period Diarrhoea	6.7 Percentage of participants
Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants While Receiving Dexlansoprazole During the 4 Week Treatment Period Headache	6.7 Percentage of participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Full analysis set: All participants who received at least 1 dose of study drug and had post-baseline data (and baseline data if applicable) for the efficacy variable.

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

Outcome measures

Outcome measures
Measure	Dexlansoprazole 30 mg n=104 Participants Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
The Percentage of Days With Neither Daytime Nor Nighttime Heartburn Over the 4 Weeks of Treatment	47.3 Percentage of days Full Range 32.18 • Interval 0.0 to 100.0

Adverse Events

Dexlansoprazole 30 mg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dexlansoprazole 30 mg n=104 participants at risk Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
Gastrointestinal disorders Diarrhoea	6.7% 7/104 • A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that started or worsened on or after Study Day 1 (defined as first dose day), and no more than 30 days after the last dose of study drug 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 Headache	6.7% 7/104 • A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that started or worsened on or after Study Day 1 (defined as first dose day), and no more than 30 days after the last dose of study drug 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, Clinical Science

Takeda

Phone: 800-778-2860

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