Trial Outcomes & Findings for Evaluation of GERDOFF Efficacy in Combination With Proton Pump Inhibitor (NCT NCT03793556)

NCT ID: NCT03793556

Last Updated: 2020-03-31

Results Overview

After 6 weeks of treatment, the changes from baseline in the score of Reflux Symptom Index questionnaire were evaluated to verify the effects of treatments on high symptoms. The RSI questionnaire examines 9 items that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 72 participants
• Primary outcome timeframe: In the first visit (baseline) and in the visit 4 (after 6 weeks of treatment)
• Results posted on: 2020-03-31

Participant Flow

A first specialist visit was performed by an ENT as per clinical practice based on patient's symptoms. Patients sent by the ENT should not have been pre-treated with PPIs and/or medical devices and/or similar products. The diagnosis was confirmed by the Gastroenterologist Investigator who recruited patients.

In this phase of the study, 72 patients were enrolled. One patient withdrew the informed consent and was excluded from the study before randomization.

Participant milestones

Measure	GERDOFF® + Omeprazole GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Overall Study STARTED	35	36
Overall Study COMPLETED	22	34
Overall Study NOT COMPLETED	13	2

Reasons for withdrawal

Measure	GERDOFF® + Omeprazole GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Overall Study Withdrawal by Subject	12	1
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Some data are missing in both arms

Baseline characteristics by cohort

Measure	GERDOFF® + Omeprazole n=35 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast	Total n=71 Participants Total of all reporting groups
Age, Continuous	46.0 years n=35 Participants	45.0 years n=36 Participants	46.0 years n=71 Participants
Sex: Female, Male Female	22 Participants n=35 Participants	32 Participants n=36 Participants	54 Participants n=71 Participants
Sex: Female, Male Male	13 Participants n=35 Participants	4 Participants n=36 Participants	17 Participants n=71 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants	0 Participants n=36 Participants	0 Participants n=71 Participants
Race (NIH/OMB) Asian	0 Participants n=35 Participants	0 Participants n=36 Participants	0 Participants n=71 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants	0 Participants n=36 Participants	0 Participants n=71 Participants
Race (NIH/OMB) Black or African American	0 Participants n=35 Participants	0 Participants n=36 Participants	0 Participants n=71 Participants
Race (NIH/OMB) White	35 Participants n=35 Participants	36 Participants n=36 Participants	71 Participants n=71 Participants
Race (NIH/OMB) More than one race	0 Participants n=35 Participants	0 Participants n=36 Participants	0 Participants n=71 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants	0 Participants n=36 Participants	0 Participants n=71 Participants
Patients with simultaneous symptoms 1 symptom	2 participants n=35 Participants	3 participants n=36 Participants	5 participants n=71 Participants
Patients with simultaneous symptoms 2 symptoms	5 participants n=35 Participants	1 participants n=36 Participants	6 participants n=71 Participants
Patients with simultaneous symptoms 3 symptoms	9 participants n=35 Participants	6 participants n=36 Participants	15 participants n=71 Participants
Patients with simultaneous symptoms 4 symptoms	11 participants n=35 Participants	17 participants n=36 Participants	28 participants n=71 Participants
Patients with simultaneous symptoms 5 symptoms	5 participants n=35 Participants	5 participants n=36 Participants	10 participants n=71 Participants
Patients with simultaneous symptoms 6 symptoms	2 participants n=35 Participants	3 participants n=36 Participants	5 participants n=71 Participants
Patients with simultaneous symptoms 7 symptoms	1 participants n=35 Participants	1 participants n=36 Participants	2 participants n=71 Participants
Hoarseness or vocal problem yes	21 participants n=35 Participants	18 participants n=36 Participants	39 participants n=71 Participants
Hoarseness or vocal problem no	14 participants n=35 Participants	18 participants n=36 Participants	32 participants n=71 Participants
Throat clearance yes	18 participants n=35 Participants	23 participants n=36 Participants	41 participants n=71 Participants
Throat clearance no	17 participants n=35 Participants	13 participants n=36 Participants	30 participants n=71 Participants
Excess of mucus in the throat or retrosternal fall of secretions yes	14 participants n=35 Participants	15 participants n=36 Participants	29 participants n=71 Participants
Excess of mucus in the throat or retrosternal fall of secretions no	21 participants n=35 Participants	21 participants n=36 Participants	42 participants n=71 Participants
Difficulty in swallowing food, fluids or pills yes	7 participants n=35 Participants	7 participants n=36 Participants	14 participants n=71 Participants
Difficulty in swallowing food, fluids or pills no	28 participants n=35 Participants	29 participants n=36 Participants	57 participants n=71 Participants
Cough after the meal or after lying yes	13 participants n=35 Participants	15 participants n=36 Participants	28 participants n=71 Participants
Cough after the meal or after lying no	22 participants n=35 Participants	21 participants n=36 Participants	43 participants n=71 Participants
Difficulty in breathing or episodes of choking yes	4 participants n=35 Participants	5 participants n=36 Participants	9 participants n=71 Participants
Difficulty in breathing or episodes of choking no	31 participants n=35 Participants	31 participants n=36 Participants	62 participants n=71 Participants
Problematic or troublesome cough yes	16 participants n=35 Participants	12 participants n=36 Participants	28 participants n=71 Participants
Problematic or troublesome cough no	19 participants n=35 Participants	24 participants n=36 Participants	43 participants n=71 Participants
Sensation of something blocked or mass in the throat yes	17 participants n=35 Participants	12 participants n=36 Participants	29 participants n=71 Participants
Sensation of something blocked or mass in the throat no	18 participants n=35 Participants	24 participants n=36 Participants	42 participants n=71 Participants
Stomach burning, thoracic pain, poor digestion of gastric acid that moves upright yes	17 participants n=35 Participants	22 participants n=36 Participants	39 participants n=71 Participants
Stomach burning, thoracic pain, poor digestion of gastric acid that moves upright no	18 participants n=35 Participants	14 participants n=36 Participants	32 participants n=71 Participants
Weight	63.0 kg n=29 Participants • Some data are missing in both arms	62.0 kg n=31 Participants • Some data are missing in both arms	62.5 kg n=60 Participants • Some data are missing in both arms
Body Mass Index	22.6 kg/m^2 n=29 Participants • Some data are missing in both arms	22.7 kg/m^2 n=31 Participants • Some data are missing in both arms	22.7 kg/m^2 n=60 Participants • Some data are missing in both arms
Number of symptoms	4 Symptom n=35 Participants	4 Symptom n=36 Participants	4 Symptom n=71 Participants

PRIMARY outcome

Timeframe: In the first visit (baseline) and in the visit 4 (after 6 weeks of treatment)

Population: Four patients in the GERFOFF + omeprazole group did not complete the Reflux Symptom Index questionnaire and could not be included in the analysis.

After 6 weeks of treatment, the changes from baseline in the score of Reflux Symptom Index questionnaire were evaluated to verify the effects of treatments on high symptoms. The RSI questionnaire examines 9 items that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).

Outcome measures

Measure	GERDOFF® + Omeprazole n=31 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire	-16.2 Score on a scale Standard Deviation 7.45	-13.7 Score on a scale Standard Deviation 10.58

SECONDARY outcome

Timeframe: In baseline Visit, Visit 2 (after 1 week), Visit 3 (after 3 weeks) and Visit 4 (after 6 weeks of treatment)

Population: Some data are missing; therefore, the number of participants in one or more rows differs from overall number analyzed.

Total score of the Reflux Symptom Index questionnaire assessed in all time-points.

The RSI questionnaire examines 9 items, that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).

Outcome measures

Measure	GERDOFF® + Omeprazole n=35 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Total Score of Reflux Symptom Index Questionnaire in All Time-points Assessed Baseline	24.2 score on a scale Standard Deviation 5.18	26.0 score on a scale Standard Deviation 4.96
Total Score of Reflux Symptom Index Questionnaire in All Time-points Assessed Visit 2	15.3 score on a scale Standard Deviation 7.86	19.6 score on a scale Standard Deviation 7.20
Total Score of Reflux Symptom Index Questionnaire in All Time-points Assessed Visit 3	12.9 score on a scale Standard Deviation 7.77	15.3 score on a scale Standard Deviation 8.08
Total Score of Reflux Symptom Index Questionnaire in All Time-points Assessed Visit 4	7.9 score on a scale Standard Deviation 6.04	12.3 score on a scale Standard Deviation 8.98

SECONDARY outcome

Timeframe: At baseline and in the visit 4, after 6 weeks of treatment

The Reflux Symptom Index questionnaire examines 9 items, including hoarseness or vocal problem that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Outcome measures

Measure	GERDOFF® + Omeprazole n=31 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Score of Hoarseness or Vocal Problem of the RSI Questionnaire Measured at the Baseline and in the Visit 4 Baseline	3.2 score on a scale Standard Deviation 1.35	2.8 score on a scale Standard Deviation 1.54
Score of Hoarseness or Vocal Problem of the RSI Questionnaire Measured at the Baseline and in the Visit 4 Visit 4	1.1 score on a scale Standard Deviation 1.33	1.6 score on a scale Standard Deviation 1.54

SECONDARY outcome

Timeframe: At baseline and in the visit 4, after 6 weeks of treatment

The Reflux Symptom Index questionnaire examines 9 items, including throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Outcome measures

Measure	GERDOFF® + Omeprazole n=31 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Score of Throat of the RSI Questionnarie Measured at the Baseline and in the Visit 4 of the RSI Questionnaire Score of Throat Clearance Baseline	3.4 score on a scale Standard Deviation 1.22	3.6 score on a scale Standard Deviation 1.00
Score of Throat of the RSI Questionnarie Measured at the Baseline and in the Visit 4 of the RSI Questionnaire Score of Throat Clearance Visit 4	1.4 score on a scale Standard Deviation 1.39	1.8 score on a scale Standard Deviation 1.37

SECONDARY outcome

Timeframe: At baseline and in the visit 4, after 6 weeks of treatment

The Reflux Symptom Index questionnaire examines 9 items, including excess of mucus in the throat or retrosternal fall of secretions that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Outcome measures

Measure	GERDOFF® + Omeprazole n=31 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Score of Excess of Mucus in the Throat or Retrosternal Fall of Secretions of the RSI Questionnaire Measured at Baseline and in the Visit 4 Baseline	2.7 score on a scale Standard Deviation 1.76	2.8 score on a scale Standard Deviation 1.77
Score of Excess of Mucus in the Throat or Retrosternal Fall of Secretions of the RSI Questionnaire Measured at Baseline and in the Visit 4 Visit 4	1.4 score on a scale Standard Deviation 1.31	1.9 score on a scale Standard Deviation 1.61

SECONDARY outcome

Timeframe: At baseline and in the visit 4, after 6 weeks of treatment

The Reflux Symptom Index questionnaire examines 9 items, including difficulty in swallowing food, fluids or pills that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Outcome measures

Measure	GERDOFF® + Omeprazole n=31 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Score of Difficulty in Swallowing Food, Fluids or Pills of the RSI Questionnaire Measured at Baseline and in the Visit 4 Baseline	1.9 score on a scale Standard Deviation 1.66	1.9 score on a scale Standard Deviation 1.84
Score of Difficulty in Swallowing Food, Fluids or Pills of the RSI Questionnaire Measured at Baseline and in the Visit 4 Visit 4	0.4 score on a scale Standard Deviation 0.71	0.6 score on a scale Standard Deviation 0.94

SECONDARY outcome

Timeframe: At baseline and in the visit 4, after 6 weeks of treatment

The Reflux Symptom Index questionnaire examines 9 items, including cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Outcome measures

Measure	GERDOFF® + Omeprazole n=31 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Score of Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 After the Meal or After Lying Baseline	2.5 score on a scale Standard Deviation 1.76	3.3 score on a scale Standard Deviation 1.44
Score of Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 After the Meal or After Lying Visit 4	0.7 score on a scale Standard Deviation 1.01	1.7 score on a scale Standard Deviation 1.47

SECONDARY outcome

Timeframe: At baseline and in the visit 4, after 6 weeks of treatment

The Reflux Symptom Index questionnaire examines 9 items, including difficulty in breathing or episodes of choking that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Outcome measures

Measure	GERDOFF® + Omeprazole n=31 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Score of Difficulty in Breathing or Episodes of Choking of the RSI Questionnaire Measured at Baseline and in the Visit 4 Baseline	1.5 score on a scale Standard Deviation 1.60	1.9 score on a scale Standard Deviation 1.69
Score of Difficulty in Breathing or Episodes of Choking of the RSI Questionnaire Measured at Baseline and in the Visit 4 Visit 4	0.5 score on a scale Standard Deviation 1.15	0.6 score on a scale Standard Deviation 0.97

SECONDARY outcome

Timeframe: At baseline and in the visit 4, after 6 weeks of treatment

The Reflux Symptom Index questionnaire examines 9 items, including problematic or troublesome cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Outcome measures

Measure	GERDOFF® + Omeprazole n=31 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Score of Problematic or Troublesome Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 Baseline	2.5 score on a scale Standard Deviation 1.65	3.7 score on a scale Standard Deviation 1.19
Score of Problematic or Troublesome Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 Visit 4	0.8 score on a scale Standard Deviation 1.17	1.5 score on a scale Standard Deviation 1.54

SECONDARY outcome

Timeframe: At baseline and in the visit 4, after 6 weeks of treatment

The Reflux Symptom Index questionnaire examines 9 items, including sensation of something blocked or mass in the throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Outcome measures

Measure	GERDOFF® + Omeprazole n=31 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Score of Sensation of Something Blocked or Mass in the Throat of the RSI Questionnaire Measured at Baseline and in the Visit 4 Baseline	3.0 score on a scale Standard Deviation 1.52	2.6 score on a scale Standard Deviation 1.75
Score of Sensation of Something Blocked or Mass in the Throat of the RSI Questionnaire Measured at Baseline and in the Visit 4 Visit 4	0.8 score on a scale Standard Deviation 1.08	1.6 score on a scale Standard Deviation 1.59

SECONDARY outcome

Timeframe: At baseline and in the visit 4, after 6 weeks of treatment

The Reflux Symptom Index questionnaire examines 9 items, including stomach burning, thoracic pain, poor digestion of gastric acid that moves upright that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.

Outcome measures

Measure	GERDOFF® + Omeprazole n=31 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Score of Stomach Burning, Thoracic Pain, Poor Digestion of Gastric Acid That Moves Upright of the RSI Questionnaire Measured at Baseline and in the Visit 4 Baseline	3.4 Score on a scale Standard Deviation 1.56	3.5 Score on a scale Standard Deviation 1.83
Score of Stomach Burning, Thoracic Pain, Poor Digestion of Gastric Acid That Moves Upright of the RSI Questionnaire Measured at Baseline and in the Visit 4 Visit 4	0.8 Score on a scale Standard Deviation 1.08	3.5 Score on a scale Standard Deviation 1.83

SECONDARY outcome

Timeframe: At visit 4 after 6 weeks of treatment

A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value < 13 on the RSI questionnaire.

Outcome measures

Measure	GERDOFF® + Omeprazole n=31 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Number of Responders V4 Yes	23 Participants	20 Participants
Number of Responders V4 No	8 Participants	16 Participants

SECONDARY outcome

Timeframe: In the Visit 6 at the end of follow-up

Responder patients of Group Gerdoff® + omeprazole were randomly assigned to receive a treatment with Gerdoff®-one tablet three times daily- All patients received a packaging of omeprazole, to be taken only if necessary, at constant dose and according to the indications of the Investigator. The scheduled duration of the follow-up period was 12 weeks.

A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value < 13 on the RSI questionnaire.

Outcome measures

Measure	GERDOFF® + Omeprazole n=9 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=8 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Number of Responders V6 yes	9 Participants	7 Participants
Number of Responders V6 No	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At baseline and in the visit 4

The Likert scale examines 9 symptoms, to be scored from 0 to 4, with a higher score indication a higher frequency of the symptom (i.e. 0=never, 1=occasionally, 2=sometimes, 3= often, 4=Always);

The Likert scale scores of single items are as following:

1. Hoarseness or vocal problem 0 1 2 3 4

2. Throat clearance 0 1 2 3 4

3. Excess of mucus in the throat or retrosternal fall of secretions 0 1 2 3 4

4. Difficulty in swallowing food, fluids or pills 0 1 2 3 4

5. Cough after the meal or after lying 0 1 2 3 4

6. Difficulty in breathing or episodes of choking 0 1 2 3 4

7. Problematic or troublesome cough 0 1 2 3 4

8. Sensation of something blocked or mass in the throat 0 1 2 3 4

9. Stomach burning, thoracic pain, poor digestion of gastric acid that moves upright 0 1 2 3 4.

Subscales are summarized to compute a total score (total score ranges from 0-36). The mean values of Likert scale total score are reported.

Outcome measures

Measure	GERDOFF® + Omeprazole n=31 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Score of Upper Symptoms Using the Likert Scale at Baseline and in the Visit V4 Baseline	19.0 Score on a scale Standard Deviation 4.301	21 Score on a scale Standard Deviation 4.557
Score of Upper Symptoms Using the Likert Scale at Baseline and in the Visit V4 Visit 4	7.4 Score on a scale Standard Deviation 5.667	11.6 Score on a scale Standard Deviation 8.083

SECONDARY outcome

Timeframe: At visit 4 after weeks of treatment

The Reflux Symptom Index questionnaire examines 9 items, to be scored from 0 to 5, with a higher score indication a higher severity of the symptom (range of total score: 0-45).

Outcome measures

Measure	GERDOFF® + Omeprazole n=31 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire Missing	1 Participants	4 Participants
Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire 1 symptom	7 Participants	2 Participants
Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire 2 symptoms	6 Participants	9 Participants
Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire 3 symptoms	13 Participants	11 Participants
Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire 4 symptoms	4 Participants	7 Participants
Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire 5 symptoms	0 Participants	2 Participants
Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire 6 symptoms	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From baseline to visit 4

In the first 6 weeks of treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug and the comparison between groups was performed using the Fisher's exact test.

Outcome measures

Measure	GERDOFF® + Omeprazole n=35 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Use of Rescue Medication (Omeprazole) During the Treatment Yes	24 Participants	28 Participants
Use of Rescue Medication (Omeprazole) During the Treatment No	11 Participants	8 Participants

SECONDARY outcome

Timeframe: In the Visit 6 after 12 weeks from baseline

During the follow-up, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.

Outcome measures

Measure	GERDOFF® + Omeprazole n=9 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=8 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Use of Rescue Medication (Omeprazole) During the Follow-up Yes	7 Participants	5 Participants
Use of Rescue Medication (Omeprazole) During the Follow-up No	2 Participants	3 Participants

SECONDARY outcome

Timeframe: From baseline to visit 4

During treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.

Outcome measures

Measure	GERDOFF® + Omeprazole n=31 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Use of Rescue Medication (Other Than Omeprazole) During Treatment Yes	0 Participants	4 Participants
Use of Rescue Medication (Other Than Omeprazole) During Treatment No	31 Participants	32 Participants

SECONDARY outcome

Timeframe: At visit 4 after weeks of treatment

Population: Four patients in the GERFOFF + omeprazole group did not complete the Reflux Symptom Index questionnaire and could not be included in the analysis.

This evaluation was expressed with a semi-quantitative ordinal scale: 0 = low, 1 = discrete, 2 = good, 3 = excellent).

Outcome measures

Measure	GERDOFF® + Omeprazole n=31 Participants GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 Participants Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Patients'Satisfaction Excellent	15 Participants	17 Participants
Patients'Satisfaction Missing	1 Participants	0 Participants
Patients'Satisfaction Low	3 Participants	1 Participants
Patients'Satisfaction Discrete	1 Participants	7 Participants
Patients'Satisfaction Good	11 Participants	11 Participants

Adverse Events

GERDOFF® + Omeprazole

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Omeprazole

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	GERDOFF® + Omeprazole n=35 participants at risk GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 participants at risk Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Cardiac disorders Atrial fibrillation	0.00% 0/35 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	2.8% 1/36 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI

Other adverse events

Measure	GERDOFF® + Omeprazole n=35 participants at risk GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg	Omeprazole n=36 participants at risk Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast
Nervous system disorders Migraine	5.7% 2/35 • Number of events 3 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	0.00% 0/36 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
General disorders Flu-like symptoms	8.6% 3/35 • Number of events 5 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	5.6% 2/36 • Number of events 2 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
General disorders Pyrexia	0.00% 0/35 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	5.6% 2/36 • Number of events 2 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Gastrointestinal disorders Diarrhea	0.00% 0/35 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	5.6% 2/36 • Number of events 2 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Infections and infestations Nasopharyngitis	2.9% 1/35 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	5.6% 2/36 • Number of events 2 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Investigations Red blood cell sedimentation rate increased	2.9% 1/35 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	0.00% 0/36 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Investigations C-reactive protein increased subjects affected / exposed	2.9% 1/35 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	0.00% 0/36 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Cardiac disorders Tachycardia	0.00% 0/35 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	2.8% 1/36 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Immune system disorders Hypersensitivity	2.9% 1/35 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	0.00% 0/36 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Respiratory, thoracic and mediastinal disorders Bronchospasm	2.9% 1/35 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	0.00% 0/36 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Nervous system disorders Clonus	2.9% 1/35 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	0.00% 0/36 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Nervous system disorders Headache	2.9% 1/35 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	0.00% 0/36 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
General disorders Chills	2.9% 1/35 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	0.00% 0/36 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Psychiatric disorders Anxiety	0.00% 0/35 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	2.8% 1/36 • Number of events 2 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Gastrointestinal disorders Nausea	11.4% 4/35 • Number of events 4 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	8.3% 3/36 • Number of events 3 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Gastrointestinal disorders Dyspepsia	2.9% 1/35 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	0.00% 0/36 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Gastrointestinal disorders Dysentery	2.9% 1/35 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	2.8% 1/36 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Gastrointestinal disorders Abdominal pain upper	0.00% 0/35 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	2.8% 1/36 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Gastrointestinal disorders Constipation	0.00% 0/35 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	2.8% 1/36 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/35 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	2.8% 1/36 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/35 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	2.8% 1/36 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Musculoskeletal and connective tissue disorders neck pain	2.9% 1/35 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	2.8% 1/36 • Number of events 2 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/35 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	2.8% 1/36 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Infections and infestations Gastroenteritis	0.00% 0/35 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	2.8% 1/36 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Infections and infestations Infection	0.00% 0/35 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	2.8% 1/36 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI
Infections and infestations Sinusitis	2.9% 1/35 • Number of events 1 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI	0.00% 0/36 • During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI

Additional Information

Dr Francesca Baldan

Sofar Spa

Phone: 0039 02 909362

Email: francesca.baldan@sofarfarm.it

Results disclosure agreements

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