Evaluation of the treatment with Gerdoff and omeprazole in respect of the treatment with omeprazole only for six weeks in patients suffering of gastroesophageal reflux disease.

Evaluation of the effect of Gerdoff administered in combination to a treatment with protonic pump inhibitors vs the only treatment with protonic pump inhibitors, administered for 6 weeks, on higher symptoms associated to gerd, in patients with first diagnosis of gastroesophageal reflux disease. An open, multicentre, prospective, randomized, double parallel treatment arms study. - Evaluation of GERDOFF and PPI in patients affected by GERD

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004503-31-IT

Enrollment

Registered

2018-12-10

Start date

2017-03-14

Completion date

Unknown

Last updated

2020-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal reflux disease MedDRA version: 20.1 Level: LLT Classification code 10018203 Term: GERD System Organ Class: 100000004856

Interventions

Trade Name: OMEPRAZEN - 20 MG CAPSULE RIGIDE GASTRORESISTENTI 14 CAPSULE Product Name: Omeprazen Pharmaceutical Form: Gastro-resistant capsule, hard

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female subject; 2. age ? 18 years; 3. first diagnosis of GERD with higher symptoms, on clinical basis made and confirmed by ORL and/or confirmed by the Gastroenterologist through RSI Questionnaire; 4. presence of extraesophageal symptoms associated to GERD; 5. RSI value = 20; 6. pazients not pre-treated with PPI, also for different problems from GERD, and/or medical devices and/orsimilar products (i.e. alginates) in the last 4 weeks. 7. cooperative patients, able to understand and respect study procedures; 8. patients able to freely provide their written informed consent to study participation; 9. patients who have freely given the consent to the treatment of study related personal data. Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28

Exclusion criteria

Exclusion criteria: 1. known infective or alkaline or acid esophagitis; 2. acute or chronic rhinosinusitis; 3. chronic bronchitis; 4. known Zollinger-Ellison syndrome, hiatal hernia over 3 cm and Barrett esophagus; 5. ongoing neoplasy; 6. uncontrolled diabetes; 7. patients with impairment hepatic function; 8. patients with rare hereditary problems of galactose intolerance; 9. patients that, according to Investigator’s opinion, cannot be enrolled also due to other diseases or concomitant therapies like atazanavir, nelfinavir, clopidogrel, posaconazolo andd erlotinib (as recommended in the SPC); 10. patient with Lapp lactase deficiency; 11. patients with glucose-galactose malabsorption syndrom; 12. patients with hypersensitivity to omeprazole, to benzimidazolic substitutes or to any of the excipients; 13. patients already in treatment with PPI or similar products; 14. chronic use of medication interfering with salivary secretion (i.e. antistaminics or inhalated steroids); 15. drugs and alcohol abuse; 16. subject unable to adequately express his disorders; 17. patients with planned or established pregnancy or patients not adopting an accepted contraceptive method; 18. brest-feeding patients; 19. missing concession of personal data treatment consent.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To verify in treated patients: 1. number and percentage of Responders/Non-Responders at Visit V4, after 6 weeks of treatment with GERDOFF®+PPI/PPI; 2. number and percentage of patients maintaining the effect of treatment at FU Visit V6 vs. end of study visit V4 after 12 weeks of treatment with GERDOFF® or non-treatment (control group) ; 3. percentage of symptoms frequency reduction at V4, after 6 weeks of treatment, vs the baseline and vs the two groups of treatment; 4. percentage of symptoms frequency reduction at V6, after 18 weeks of treatment, vs V4 and vs. the two groups of treatments; 5. global patient satisfaction in respect of the treatment during the treatment period; 6. the potential concomitant utilization of other medication/products, not allowed, used as “rescue medication” during the first 6 weeks of treatment; 7. the potential concomitant use of “rescue medication”, permitted and not permitted, in the FU period.;Main Objective: To evaluate the capacity of GERDOFF to improve higher symptoms in association with PPI (omeprazole) vs. the only treatment with PPI (omeprazole) during 6 weeks of treatment and during the following retention period of 12 weeks.;Primary end point(s): At Visit V4 (end of the first phase of the study) it will be evaluated the difference in the respect of the baseline of the RSI questionnaire score to verify the effect of the treatment on higher symptoms.;Timepoint(s) of evaluation of this end point: 6 weeks	—

Measure

Time frame

Secondary Objective: To verify in treated patients: 1. number and percentage of Responders/Non-Responders at Visit V4, after 6 weeks of treatment with GERDOFF®+PPI/PPI; 2. number and percentage of patients maintaining the effect of treatment at FU Visit V6 vs. end of study visit V4 after 12 weeks of treatment with GERDOFF® or non-treatment (control group) ; 3. percentage of symptoms frequency reduction at V4, after 6 weeks of treatment, vs the baseline and vs the two groups of treatment; 4. percentage of symptoms frequency reduction at V6, after 18 weeks of treatment, vs V4 and vs. the two groups of treatments; 5. global patient satisfaction in respect of the treatment during the treatment period; 6. the potential concomitant utilization of other medication/products, not allowed, used as “rescue medication” during the first 6 weeks of treatment; 7. the potential concomitant use of “rescue medication”, permitted and not permitted, in the FU period.;Main Objective: To evaluate the capacity of GERDOFF to improve higher symptoms in association with PPI (omeprazole) vs. the only treatment with PPI (omeprazole) during 6 weeks of treatment and during the following retention period of 12 weeks.;Primary end point(s): At Visit V4 (end of the first phase of the study) it will be evaluated the difference in the respect of the baseline of the RSI questionnaire score to verify the effect of the treatment on higher symptoms.;Timepoint(s) of evaluation of this end point: 6 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): "Rescue medication" intake, when needed during the FU phase;Timepoint(s) of evaluation of this end point: During the 18 weeks of study	—

Countries

Italy

Contacts

Public ContactDirezione Scientifica

SOFAR S.p.A.

laura.patrucco@sofarfarm.it02 9093621

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026