Gastro-oesophageal Reflux DiseaseNCT03793556
Evaluation of GERDOFF Efficacy in Combination With Proton Pump Inhibitor
A study testing GERDOFF® + Omeprazole and Omeprazole in people with Gastro-oesophageal Reflux Disease, run by SOFAR S.p.A. at 1 site in Italy.
Trial summary
The aim of the present study was to evaluate the effect of a 6-weeks treatment of a CE-marked combination oral formulation of hyaluronic acid with chondroitin sulphate and aluminium hydroxide (GERDOFF®), in addition to proton pump inhibitors (PPI) at the standard dose, versus PPI only, in patients with first diagnosed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-oesophageal Reflux Disease
- What is being tested?
- GERDOFF® + Omeprazole and Omeprazole
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 5 May 2017to 11 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥ 18 years;
- First diagnosis of GERD with upper symptoms, made on a clinical basis and confirmed by an ENT and/or confirmed by a Gastroenterologist using a RSI questionnaire;
- Presence of extra-oesophageal symptoms associated with GERD;
- RSI score ≥ 20;
- Patients not pre-treated with PPIs, even for problems different from GERD, and/or with medical devices and/or similar products (e.g. antacid alginates etc..) in the last 4 weeks;
- Cooperative patients, able to understand and adhere to the study procedures;
- Patient able to freely give their written informed consent to study participation;
- Patients that freely gave the consent to management of personal data related to the study.
Who cannot join
- Known infective oesophagitis or oesophagitis due to acid or alkaline substances;
- Acute or chronic rhinosinusitis;
- Chronic bronchitis;
- Known Zollinger-Ellison syndrome, hiatal hernia greater than 3 cm and Barrett oesophagus;
- Ongoing neoplasias;
- Uncontrolled diabetes;
Show all 18Show fewer
- Patients with impaired liver function;
- Patients with rare hereditary problems of galactose intolerance;
- Patients that, based on Investigator's opinion, could not take part in the study due to other diseases or concomitant therapies, such as the intake of atazanavir, nelfinavir, clopidogrel, posaconazole and erlotinib (as recommended in the Summary of Product Characteristics of Gerdoff®);
- Patients with deficiency of Lapp lactase;
- Patients with syndrome of glu-gal malabsorption;
- Patients with hypersensitivity to omeprazole, substitute benzymidazolic or any of the excipients;
- Patients already in treatment with PPIs or similar products;
- Chronic use of drugs that interfere with the salivary secretion (e.g. anti-histamines or inhaled steroids);
- Abuse of drug or alcohol;
- Inability of the subject to adequately express his/her disturbances;
- Patients with planned or ascertained pregnancy or that did not adopt an accepted contraceptive method;
- Lactating patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of GERDOFF in Combination With a 6-week Therapy Based on Proton Pump Inhibitors Versus Proton Pump Inhibitors Alone on GERD-high Symptoms in Patients With Primary Diagnosis of Gastroesophageal Reflux Disease.
The aim of the present study was to evaluate the effect of a 6-weeks treatment of a CE-marked combination oral formulation of hyaluronic acid with chondroitin sulphate and aluminium hydroxide (GERDOFF®), in addition to proton pump inhibitors (PPI) at the standard dose, versus PPI only, in patients with first diagnosed clinical presentation of extra-esophageal GERD symptoms.
The investigators verified the reduction of symptoms frequency, using a Likert questionnaire, and severity, using the Reflux Symptom Index (RSI) questionnaire, to evaluate the proportion of Responders and Non-Responder patients in these two groups after 6 weeks of treatment, compared to baseline. Moreover investigators evaluated the persistence of effects of GERDOFF® + PPI treatment on extraesophageal symptoms, after a 12-weeks follow up, only in responder patients.
Read the detailed description
Cough, hoarseness, prolonged voice lowering, and vocal timbre modification, without any documentable cause, are considered as minor disorders for which patients do not receive adequate attention. These disorders may represent extra-esophageal manifestations of gastro-oesophagea reflux. Accurate diagnosis and gastro-oesophageal reflux therapy have been proved as useful to improve patients' quality of life.
The aim of the present study was to evaluate, in first diagnosed patients presenting with upper symptoms associated with GERD, the effect of a 6-week treatment with a combination based on CS, HA and aluminium hydroxide (Gerdoff®), co-administered with a treatment with PPIs, compared to treatment with PPIs as monotherapy, i.e. to verify, in patients treated with the combination of the two products, the reduction in symptoms frequency by means of a Likert questionnaire and the severity of upper symptoms by means of the Reflux Symptom Index (RSI) questionnaire, and to collect safety data. After 6 weeks of treatment, patients included in the two groups were then classified as responders or non-responders. Responder patients were defined as those patients that, at the 6th week of treatment, reached a RSI score decreased for at least 50% compared to baseline and an absolute value < 13.
Furthermore, the maintenance of the effect of treatment on the extra-oesophageal symptoms was evaluated after a period of follow-up lasting 12 weeks, which could be entered only by responder patients randomised in the Gerdoff®-PPI arm. Patients included in the follow-up period were randomised to receive Gerdoff® or no treatment (control group). Safety data were also evaluated in the group of patients that continued in the follow-up period.
- Conditions
- Gastro-oesophageal Reflux Disease
- Being tested
- GERDOFF® + Omeprazole, Omeprazole
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GERDOFF® + OmeprazoleDevice
Also called GERDOFF®
GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg + Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).
OmeprazoleDrug
Also called Omeprazen
Omeprazole, 2 capsules 20 mg, once a day before breakfast
| Study group | Role | What they receive |
|---|---|---|
| GERDOFF® + omeprazole | Experimental | 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).
Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Receives: Device: GERDOFF® + Omeprazole |
| Omeprazole | Active comparator | Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). Receives: Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire
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).
Measured: In the first visit (baseline) and in the visit 4 (after 6 weeks of treatment)
Secondary outcomes (18)
Total Score of Reflux Symptom Index Questionnaire in All Time-points Assessed
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).
Measured: In baseline Visit, Visit 2 (after 1 week), Visit 3 (after 3 weeks) and Visit 4 (after 6 weeks of treatment)
Score of Hoarseness or Vocal Problem of the RSI Questionnaire Measured at the Baseline and in the Visit 4
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.
Measured: At baseline and in the visit 4, after 6 weeks of treatment
Score of Throat of the RSI Questionnarie Measured at the Baseline and in the Visit 4 of the RSI Questionnaire Score of Throat Clearance
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.
Measured: At baseline and in the visit 4, after 6 weeks of treatment
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
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.
Measured: At baseline and in the visit 4, after 6 weeks of treatment
Score of Difficulty in Swallowing Food, Fluids or Pills of the RSI Questionnaire Measured at Baseline and in the Visit 4
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.
Measured: At baseline and in the visit 4, after 6 weeks of treatment
Score of Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 After the Meal or After Lying
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.
Measured: At baseline and in the visit 4, after 6 weeks of treatment
Score of Difficulty in Breathing or Episodes of Choking of the RSI Questionnaire Measured at Baseline and in the Visit 4
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.
Measured: At baseline and in the visit 4, after 6 weeks of treatment
Score of Problematic or Troublesome Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4
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.
Measured: At baseline and in the visit 4, after 6 weeks of treatment
Score of Sensation of Something Blocked or Mass in the Throat of the RSI Questionnaire Measured at Baseline and in the Visit 4
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.
Measured: At baseline and in the visit 4, after 6 weeks of treatment
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
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.
Measured: At baseline and in the visit 4, after 6 weeks of treatment
Number of Responders V4
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.
Measured: At visit 4 after 6 weeks of treatment
Number of Responders V6
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.
Measured: In the Visit 6 at the end of follow-up
Score of Upper Symptoms Using the Likert Scale at Baseline and in the Visit V4
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:
- Hoarseness or vocal problem 0 1 2 3 4
- Throat clearance 0 1 2 3 4
- Excess of mucus in the throat or retrosternal fall of secretions 0 1 2 3 4
- Difficulty in swallowing food, fluids or pills 0 1 2 3 4
- Cough after the meal or after lying 0 1 2 3 4
- Difficulty in breathing or episodes of choking 0 1 2 3 4
- Problematic or troublesome cough 0 1 2 3 4
- Sensation of something blocked or mass in the throat 0 1 2 3 4
- 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.
Measured: At baseline and in the visit 4
Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire
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).
Measured: At visit 4 after weeks of treatment
Use of Rescue Medication (Omeprazole) During the Treatment
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.
Measured: From baseline to visit 4
Use of Rescue Medication (Omeprazole) During the Follow-up
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.
Measured: In the Visit 6 after 12 weeks from baseline
Use of Rescue Medication (Other Than Omeprazole) During Treatment
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.
Measured: From baseline to visit 4
Patients'Satisfaction
This evaluation was expressed with a semi-quantitative ordinal scale: 0 = low, 1 = discrete, 2 = good, 3 = excellent).
Measured: At visit 4 after weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start5 May 2017
- Primary completion20 Sep 2018
- Study completion11 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastro-oesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients was randomized in an open-label treatment (in a ratio 1:1) and treated with the investigational medical device (IMD) + proton pump inhibitor (PPI) or PPI only for 6 weeks. At the end of treatment visit (V4) only patients who were classified as responders and belonging to the GERDOFF®+PPI group were included in the follow-up phase for 12 further weeks. During the follow-up, patients were randomized to an open-label treatment (in a 1:1 ratio) to GERDOFF® group or control group that will not receive any treatment for 12 weeks in order to evaluate the maintenance of treatment effects. To safeguard the health and well-being of patients, and to keep under control the possible upper symptoms of GERD that could appear, all patients that continued in the follow-up period received omeprazole as rescue medication, in a quantity adequate to cover the entire follow-up period.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOFAR S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alessandro Repici, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793556
- Sponsor's protocol ID
- PSC-DS GERD AP 16
- Status last verified
- Mar 2020
- First submitted
- 11 Dec 2018
- Last updated
- 31 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of GERDOFF in Combination With a 6-week Therapy Based on Proton Pump Inhibitors Versus Proton Pump Inhibitors Alone on GERD-high Symptoms in Patients With Primary Diagnosis of Gastroesophageal Reflux Disease.
- ClinicalTrials.gov ID
- NCT03793556
- Acronym / sponsor ID
- PSC-DS GERD AP 16
- Conditions
- Gastro-oesophageal Reflux Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- SOFAR S.p.A.Industry (pharma, biotech, devices)
- Study start
- 5 May 2017 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 4 Jan 2019 (actual)
- Results
- Posted 18 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study was to evaluate the effect of a 6-weeks treatment of a CE-marked combination oral formulation of hyaluronic acid with chondroitin sulphate and aluminium hydroxide (GERDOFF®), in addition to proton pump inhibitors (PPI) at the standard dose, versus PPI only, in patients with first diagnosed clinical presentation of extra-esophageal GERD symptoms.
The investigators verified the reduction of symptoms frequency, using a Likert questionnaire, and severity, using the Reflux Symptom Index (RSI) questionnaire, to evaluate the proportion of Responders and Non-Responder patients in these two groups after 6 weeks of treatment, compared to baseline. Moreover investigators evaluated the persistence of effects of GERDOFF® + PPI treatment on extraesophageal symptoms, after a 12-weeks follow up, only in responder patients.
Detailed description
Cough, hoarseness, prolonged voice lowering, and vocal timbre modification, without any documentable cause, are considered as minor disorders for which patients do not receive adequate attention. These disorders may represent extra-esophageal manifestations of gastro-oesophagea reflux. Accurate diagnosis and gastro-oesophageal reflux therapy have been proved as useful to improve patients' quality of life.
The aim of the present study was to evaluate, in first diagnosed patients presenting with upper symptoms associated with GERD, the effect of a 6-week treatment with a combination based on CS, HA and aluminium hydroxide (Gerdoff®), co-administered with a treatment with PPIs, compared to treatment with PPIs as monotherapy, i.e. to verify, in patients treated with the combination of the two products, the reduction in symptoms frequency by means of a Likert questionnaire and the severity of upper symptoms by means of the Reflux Symptom Index (RSI) questionnaire, and to collect safety data. After 6 weeks of treatment, patients included in the two groups were then classified as responders or non-responders. Responder patients were defined as those patients that, at the 6th week of treatment, reached a RSI score decreased for at least 50% compared to baseline and an absolute value < 13.
Furthermore, the maintenance of the effect of treatment on the extra-oesophageal symptoms was evaluated after a period of follow-up lasting 12 weeks, which could be entered only by responder patients randomised in the Gerdoff®-PPI arm. Patients included in the follow-up period were randomised to receive Gerdoff® or no treatment (control group). Safety data were also evaluated in the group of patients that continued in the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients was randomized in an open-label treatment (in a ratio 1:1) and treated with the investigational medical device (IMD) + proton pump inhibitor (PPI) or PPI only for 6 weeks. At the end of treatment visit (V4) only patients who were classified as responders and belonging to the GERDOFF®+PPI group were included in the follow-up phase for 12 further weeks. During the follow-up, patients were randomized to an open-label treatment (in a 1:1 ratio) to GERDOFF® group or control group that will not receive any treatment for 12 weeks in order to evaluate the maintenance of treatment effects. To safeguard the health and well-being of patients, and to keep under control the possible upper symptoms of GERD that could appear, all patients that continued in the follow-up period received omeprazole as rescue medication, in a quantity adequate to cover the entire follow-up period.
| Arm | Type | Receives |
|---|---|---|
| GERDOFF® + omeprazole | Experimental | Device: GERDOFF® + OmeprazoleGERDOFF® (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). Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). |
| Omeprazole | Active comparator | Drug: OmeprazoleOmeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects aged ≥ 18 years;
- First diagnosis of GERD with upper symptoms, made on a clinical basis and confirmed by an ENT and/or confirmed by a Gastroenterologist using a RSI questionnaire;
- Presence of extra-oesophageal symptoms associated with GERD;
- RSI score ≥ 20;
- Patients not pre-treated with PPIs, even for problems different from GERD, and/or with medical devices and/or similar products (e.g. antacid alginates etc..) in the last 4 weeks;
Key exclusion criteria (18 listed)
- Known infective oesophagitis or oesophagitis due to acid or alkaline substances;
- Acute or chronic rhinosinusitis;
- Chronic bronchitis;
- Known Zollinger-Ellison syndrome, hiatal hernia greater than 3 cm and Barrett oesophagus;
- Ongoing neoplasias;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GERDOFF® + OmeprazoleAlso: GERDOFF®GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg + Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days). | Device | GERDOFF® + omeprazole |
| OmeprazoleAlso: OmeprazenOmeprazole, 2 capsules 20 mg, once a day before breakfast | Drug | Omeprazole |
Primary outcome
Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire
Time frame: In the first visit (baseline) and in the visit 4 (after 6 weeks of treatment)
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).
18 secondary outcomes
Total Score of Reflux Symptom Index Questionnaire in All Time-points Assessed
Time frame: In baseline Visit, Visit 2 (after 1 week), Visit 3 (after 3 weeks) and Visit 4 (after 6 weeks of treatment)
Score of Hoarseness or Vocal Problem of the RSI Questionnaire Measured at the Baseline and in the Visit 4
Time frame: At baseline and in the visit 4, after 6 weeks of treatment
Score of Throat of the RSI Questionnarie Measured at the Baseline and in the Visit 4 of the RSI Questionnaire Score of Throat Clearance
Time frame: At baseline and in the visit 4, after 6 weeks of treatment
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
Time frame: At baseline and in the visit 4, after 6 weeks of treatment
Score of Difficulty in Swallowing Food, Fluids or Pills of the RSI Questionnaire Measured at Baseline and in the Visit 4
Time frame: At baseline and in the visit 4, after 6 weeks of treatment
Score of Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 After the Meal or After Lying
Time frame: At baseline and in the visit 4, after 6 weeks of treatment
Score of Difficulty in Breathing or Episodes of Choking of the RSI Questionnaire Measured at Baseline and in the Visit 4
Time frame: At baseline and in the visit 4, after 6 weeks of treatment
Score of Problematic or Troublesome Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4
Time frame: At baseline and in the visit 4, after 6 weeks of treatment
Score of Sensation of Something Blocked or Mass in the Throat of the RSI Questionnaire Measured at Baseline and in the Visit 4
Time frame: At baseline and in the visit 4, after 6 weeks of treatment
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
Time frame: At baseline and in the visit 4, after 6 weeks of treatment
Number of Responders V4
Time frame: At visit 4 after 6 weeks of treatment
Number of Responders V6
Time frame: In the Visit 6 at the end of follow-up
Score of Upper Symptoms Using the Likert Scale at Baseline and in the Visit V4
Time frame: At baseline and in the visit 4
Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire
Time frame: At visit 4 after weeks of treatment
Use of Rescue Medication (Omeprazole) During the Treatment
Time frame: From baseline to visit 4
Use of Rescue Medication (Omeprazole) During the Follow-up
Time frame: In the Visit 6 after 12 weeks from baseline
Use of Rescue Medication (Other Than Omeprazole) During Treatment
Time frame: From baseline to visit 4
Patients'Satisfaction
Time frame: At visit 4 after weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Repici, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GERDOFF® + Omeprazole and Omeprazole in people with Gastro-oesophageal Reflux Disease, run by SOFAR S.p.A. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire (time frame: In the first visit (baseline) and in the visit 4 (after 6 weeks of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.