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Completed

NCT Number: NCT03793556

Evaluation of GERDOFF Efficacy in Combination With Proton Pump Inhibitor

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.

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Key information

Conditions

Gastro-oesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

dr Alessandro Repici

Rozzano, MI, 20089, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

GERDOFF® + Omeprazole

Device

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).

Other names: GERDOFF®

Omeprazole

Drug

Omeprazole, 2 capsules 20 mg, once a day before breakfast

Other names: Omeprazen

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

    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).

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

  6. 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

    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.

  7. 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

    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.

  8. 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

    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.

  9. 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

    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.

  10. 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

    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.

  11. Number of Responders V4

    Time frame: 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.

  12. Number of Responders V6

    Time frame: 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.

  13. Score of Upper Symptoms Using the Likert Scale at Baseline and in the Visit V4

    Time frame: 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:

    • 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.

  14. Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire

    Time frame: 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).

  15. Use of Rescue Medication (Omeprazole) During the Treatment

    Time frame: 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.

  16. Use of Rescue Medication (Omeprazole) During the Follow-up

    Time frame: 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.

  17. Use of Rescue Medication (Other Than Omeprazole) During Treatment

    Time frame: 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.

  18. Patients'Satisfaction

    Time frame: At visit 4 after weeks of treatment

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

Sponsors and collaborators

Lead sponsor

SOFAR S.p.A.

Industry

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 4, 2019
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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