Trial Outcomes & Findings for Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study (NCT NCT00693225)

Results Overview

After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows: LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

91 participants

Primary outcome timeframe

8 weeks

Results posted on

2012-09-20

Participant Flow

Subjects were recruited from the Mayo Clinic in Rochester, MN from June 20, 2008 to May 24, 2010.

One subject on the PM dose arm did not receive allocated intervention because the subject changed their mind soon after randomization.

Participant milestones

Participant milestones
Measure	Omeprazole/Sodium Bicarbonate AM Dose 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning	Omeprazole/Sodium Bicarbonate PM Dose 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
Overall Study STARTED	43	48
Overall Study COMPLETED	41	43
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Omeprazole/Sodium Bicarbonate AM Dose 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning	Omeprazole/Sodium Bicarbonate PM Dose 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
Overall Study Lost to Follow-up	1	2
Overall Study Adverse Event	1	3

Baseline Characteristics

Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omeprazole/Sodium Bicarbonate AM Dose n=43 Participants 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning	Omeprazole/Sodium Bicarbonate PM Dose n=48 Participants 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime	Total n=91 Participants Total of all reporting groups
Age Continuous	58 years n=5 Participants	59 years n=7 Participants	58 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	33 Participants n=7 Participants	63 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants	48 participants n=7 Participants	91 participants n=5 Participants
Body Mass Index (BMI)	31.1 kg/m^2 n=5 Participants	31.1 kg/m^2 n=7 Participants	31.1 kg/m^2 n=5 Participants
Esophagitis Severity LA grade C (moderate esophagitis)	26 participants n=5 Participants	33 participants n=7 Participants	59 participants n=5 Participants
Esophagitis Severity LA grade D (severe esophagitis)	17 participants n=5 Participants	15 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows: LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up.

Outcome measures

Outcome measures
Measure	Omeprazole/Sodium Bicarbonate AM Dose n=41 Participants 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning	Omeprazole/Sodium Bicarbonate PM Dose n=43 Participants 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
Percent of Subjects Overall Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment Healed	83 percentage of patients	81 percentage of patients
Percent of Subjects Overall Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment Improved	15 percentage of patients	14 percentage of patients
Percent of Subjects Overall Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment Same or worse	2 percentage of patients	5 percentage of patients

SECONDARY outcome

Timeframe: 8 weeks

Population: 25 of the 41 participants in the Omeprazole/sodium bicarbonate AM dose arm were LA Grade C. 29 of the 43 participants in the Omeprazole/sodium bicarbonate AM dose arm were LA Grade C.

After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows: LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up.

Outcome measures

Outcome measures
Measure	Omeprazole/Sodium Bicarbonate AM Dose n=25 Participants 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning	Omeprazole/Sodium Bicarbonate PM Dose n=29 Participants 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
Percent of Subjects With Moderate Esophagitis (LA Grade C) Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment Healed	88 percentage of participants	79 percentage of participants
Percent of Subjects With Moderate Esophagitis (LA Grade C) Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment Improved	12 percentage of participants	14 percentage of participants
Percent of Subjects With Moderate Esophagitis (LA Grade C) Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment Same or worse	0 percentage of participants	7 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: 16 of the 41 participants in the Omeprazole/sodium bicarbonate AM dose arm were LA Grade D. 14 of the 43 participants in the Omeprazole/sodium bicarbonate PM dose arm were LA Grade D.

After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows: LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up.

Outcome measures

Outcome measures
Measure	Omeprazole/Sodium Bicarbonate AM Dose n=16 Participants 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning	Omeprazole/Sodium Bicarbonate PM Dose n=14 Participants 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
Percent of Subjects With Severe Esophagitis (LA Grade D) Who Healed, Improved, or Stayed the Same After 8 Weeks of Treatment Same	6 percentage of participants	0 percentage of participants
Percent of Subjects With Severe Esophagitis (LA Grade D) Who Healed, Improved, or Stayed the Same After 8 Weeks of Treatment Healed	75 percentage of participants	86 percentage of participants
Percent of Subjects With Severe Esophagitis (LA Grade D) Who Healed, Improved, or Stayed the Same After 8 Weeks of Treatment Improved	19 percentage of participants	14 percentage of participants

Adverse Events

Omeprazole/Sodium Bicarbonate AM Dose

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Omeprazole/Sodium Bicarbonate PM Dose

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Omeprazole/Sodium Bicarbonate AM Dose n=41 participants at risk 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning	Omeprazole/Sodium Bicarbonate PM Dose n=43 participants at risk 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
Musculoskeletal and connective tissue disorders Joint and muscle pain	2.4% 1/41 • Number of events 1 • Adverse events were collected over the eight weeks subjects were on study drug.	0.00% 0/43 • Adverse events were collected over the eight weeks subjects were on study drug.
Blood and lymphatic system disorders peripheral edema/increased blood pressue	0.00% 0/41 • Adverse events were collected over the eight weeks subjects were on study drug.	7.0% 3/43 • Number of events 3 • Adverse events were collected over the eight weeks subjects were on study drug.

Additional Information

Dr. Yvonne Romero

Mayo Clinic

Phone: 507-266-9156

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place