Trial Outcomes & Findings for Phase III Study Comparing Zegerid® With Losec® for the Relief of Heartburn Associated With Gastroesophageal Reflux Disease (NCT NCT01493089)

NCT ID: NCT01493089

Last Updated: 2013-08-13

Results Overview

Reduction in severity of heartburn by 2 points or more on a 9-point Likert severity scale, which is sustained for 45 minutes or more

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 239 participants
• Primary outcome timeframe: up to 14 days following treatment
• Results posted on: 2013-08-13

Participant Flow

Participant milestones

Measure	Zegerid Treatment of heartburn with 20mg Zegerid suspension plus over-encapsulated placebo capsule once a day	Losec Treatment of heartburn with 20mg Losec over-capsulated capsule plus placebo suspension once a day
Overall Study STARTED	122	117
Overall Study COMPLETED	119	114
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	Zegerid Treatment of heartburn with 20mg Zegerid suspension plus over-encapsulated placebo capsule once a day	Losec Treatment of heartburn with 20mg Losec over-capsulated capsule plus placebo suspension once a day
Overall Study Protocol Violation	2	2
Overall Study Withdrawal by Subject	1	0
Overall Study Physician Decision	0	1

Baseline Characteristics

Phase III Study Comparing Zegerid® With Losec® for the Relief of Heartburn Associated With Gastroesophageal Reflux Disease

Baseline characteristics by cohort

Measure	Zegerid n=122 Participants Treatment of heartburn with Zegerid	Losec n=117 Participants Treatment of heartburn with Losec	Total n=239 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	109 Participants n=5 Participants	110 Participants n=7 Participants	219 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Age Continuous	45.0 years STANDARD_DEVIATION 15.43 • n=5 Participants	44.4 years STANDARD_DEVIATION 13.91 • n=7 Participants	44.7 years STANDARD_DEVIATION 14.69 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	69 Participants n=7 Participants	131 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	48 Participants n=7 Participants	108 Participants n=5 Participants
Region of Enrollment Poland	48 participants n=5 Participants	49 participants n=7 Participants	97 participants n=5 Participants
Region of Enrollment Bulgaria	14 participants n=5 Participants	17 participants n=7 Participants	31 participants n=5 Participants
Region of Enrollment Czech Republic	17 participants n=5 Participants	15 participants n=7 Participants	32 participants n=5 Participants
Region of Enrollment Hungary	19 participants n=5 Participants	14 participants n=7 Participants	33 participants n=5 Participants
Region of Enrollment Romania	17 participants n=5 Participants	18 participants n=7 Participants	35 participants n=5 Participants
Region of Enrollment United Kingdom	7 participants n=5 Participants	4 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 14 days following treatment

Population: mITT

Reduction in severity of heartburn by 2 points or more on a 9-point Likert severity scale, which is sustained for 45 minutes or more

Outcome measures

Measure	Zegerid Group n=117 Participants 20mg Zegerid suspension plus over-encapsulated placebo capsule	Losec Group n=111 Participants 20mg Losec over-encapsulated capsule plus placebo suspension
Determination of Median Time to Sustained Partial Response as Defined by Reduction in Likert Severity Scale Used to Assess Pain Associated With Heartburn in the Patient	37.5 Minutes Interval 30.0 to 45.0	37.5 Minutes Interval 30.0 to 45.0

SECONDARY outcome

Timeframe: up to 14 days

Population: mITT

Reduction in severity of heartburn by 2 points or more on a 9-point Likert severity scale, which is sustained for 45 minutes or more

Outcome measures

Measure	Zegerid Group n=117 Participants 20mg Zegerid suspension plus over-encapsulated placebo capsule	Losec Group n=111 Participants 20mg Losec over-encapsulated capsule plus placebo suspension
Median Time to Sustained Partial Response	37.5 Minutes Interval 30.0 to 45.0	37.5 Minutes Interval 30.0 to 45.0

SECONDARY outcome

Timeframe: 14 days

Population: mITT

Time to sustained total relief, defined as zero severity (no heartburn) on a 9-point Likert severity scale, which is sustained for 45 minutes or more

Outcome measures

Measure	Zegerid Group n=117 Participants 20mg Zegerid suspension plus over-encapsulated placebo capsule	Losec Group n=111 Participants 20mg Losec over-encapsulated capsule plus placebo suspension
Median Time to Sustained Total Relief	105.0 Minutes Interval 90.0 to 120.0	105.0 Minutes Interval 75.0 to 120.0

SECONDARY outcome

Timeframe: up to 14 days

Population: mITT

percentage of patients who have achieved sustained partial response, sustained response, or sustained total relief, by 45 minutes

Outcome measures

Measure	Zegerid Group n=117 Participants 20mg Zegerid suspension plus over-encapsulated placebo capsule	Losec Group n=111 Participants 20mg Losec over-encapsulated capsule plus placebo suspension
Percentage of Patients Responding in 45 Minutes	65 percentage of patients Interval 55.6 to 73.5	62.2 percentage of patients Interval 52.5 to 71.2

SECONDARY outcome

Timeframe: 14 days

Population: mITT

Proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 60 minutes

Outcome measures

Measure	Zegerid Group n=117 Participants 20mg Zegerid suspension plus over-encapsulated placebo capsule	Losec Group n=111 Participants 20mg Losec over-encapsulated capsule plus placebo suspension
Percentage of Patients Responding in 60 Minutes	74.4 Percentage of patients Interval 65.5 to 82.0	78.4 Percentage of patients Interval 69.6 to 85.6

SECONDARY outcome

Timeframe: 14 days

Population: mITT

Proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 90 minutes

Outcome measures

Measure	Zegerid Group n=117 Participants 20mg Zegerid suspension plus over-encapsulated placebo capsule	Losec Group n=111 Participants 20mg Losec over-encapsulated capsule plus placebo suspension
Percentage of Patients Responding in 90 Minutes	88.0 Percentage of patients Interval 80.7 to 93.3	85.6 Percentage of patients Interval 77.6 to 91.5

Adverse Events

Zegerid

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Losec

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Zegerid n=122 participants at risk Treatment of heartburn with Zegerid	Losec n=117 participants at risk Treatment of heartburn with Losec
Gastrointestinal disorders Abdominal distension	0.82% 1/122 • Number of events 1	0.00% 0/117
Gastrointestinal disorders abdominal pain upper	0.82% 1/122 • Number of events 1	0.00% 0/117
Gastrointestinal disorders flatulence	0.82% 1/122 • Number of events 1	0.00% 0/117
Gastrointestinal disorders Nausea	0.82% 1/122 • Number of events 1	0.85% 1/117 • Number of events 1
General disorders Influenza like illness	0.00% 0/122	0.85% 1/117 • Number of events 1
Infections and infestations paronychia	0.00% 0/122	0.85% 1/117 • Number of events 1
Nervous system disorders headache	0.00% 0/122	0.85% 1/117 • Number of events 1
Respiratory, thoracic and mediastinal disorders epistaxis	0.00% 0/122	0.85% 1/117 • Number of events 1

Additional Information

Dr. Richard Ng Kwet Shing

Norgine Ltd

Phone: +441895453584

Email: RNg@Norgine.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place