Clinical trial NCT04202692: Effect of a Combination Oral Formulation of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate in Patients With Gastro-Esophageal Reflux Disease Not Fully Satisfied With Their Treatment
Official title: Evaluation of the Performance and Safety of an Oral Formulation of Hyaluronic Acid With Chondroitin Sulphate and Magnesium Trisilicate (GERDOff® Plus) in Patients With Gastro-Esophageal Reflux Disease: A Double-blind, Placebo-controlled, Randomized, Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro Esophageal Reflux
Lead sponsor: SOFAR S.p.A.
Sponsor class: INDUSTRY
First posted: 2019-12-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a post-market, multi-center, double-blind, placebo-controlled, randomized, cross-over study with GERDOff Plus added on top of the current PPI treatment in patients with GERD. The aim of the study is to evaluate the performance of GERDOff Plus, a class III medical device, consisting in a hyaluronic acid, chondroitin sulphate and magnesium trisilicate, in addition to the PPIs, in patients with GERD not fully satisfied with their current treatment with PPIs.

Patients will receive either GERDOff Plus or placebo q.i.d. for 21 days followed by a wash-out period of 3 weeks. After the wash-out period, the patients will receive either placebo or GERDOff Plus respectively


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent (ICF): a written informed consent must be obtained prior to any study related procedure being performed
* Male and female out-patients aged 18 to 80 years
* GERD diagnosis confirmed through a validated questionnaire (GERDQ score ≥ 8).
* EGD endoscopy performed within 1 year before screening
* Patients in continuous or intermittent treatment with PPI for at least 1 year and continuously for at least 4 weeks prior to study entry
* Patients not fully satisfied with current PPI treatment (1-3 score on 5-points Likert scale)

Exclusion Criteria:

* Dyspeptic patients or patients with overlapping symptoms with GI diseases other than GERD
* Histological evidence of Barrett's oesophagus \> 1 cm in EGD endoscopy
* Peptic stricture in EGD endoscopy
* Concurrent findings in the EGD endoscopy that might interfere with the participation to the study (e.g cancer, peptic ulcer) as judged by the investigator
* Known impaired kidney or liver function at screening
* Presence of any relevant severe condition or clinically relevant abnormal parameters that in the opinion of the investigator may interfere with the participation to the study
* Medication use (including H2 antagonists, alginates, baclofen, NSAIDS, prokinetics, antidepressants) that may interfere with GERD symptom assessment within 2 weeks before the start of the study or during the study
* Pregnancy or breast-feeding
* Females of childbearing potential not employing adequate contraceptive methods
* Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable)
* History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent
* History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements
* Treatment with any investigational drug within the previous 30 days

Primary outcomes:
measure: Overall patient satisfaction
timeFrame: From baseline to the end of the respective 3-week treatment period
Secondary outcomes:
measure: Change of weekly frequency of each symptom using the Gastro Esophageal Reflux Disease Questionnaire (GERDQ) questionnaire
timeFrame: From baseline to the end of the respective 3-week treatment period
measure: Change of weekly global score of symptoms using the Gastro Esophageal Reflux Disease Questionnaire (GERDQ) questionnaire
timeFrame: From baseline to the end of the respective 3-week treatment period
measure: Change of the intensity of each symptom using the Reflux Symptom Index (RSI) questionnaire
timeFrame: From baseline to the end of the respective 3-week treatment period
measure: Change of the global score using the Reflux Symptom Index (RSI) questionnaire
timeFrame: From baseline to the end of the respective 3-week treatment period
measure: Assessment of palatability
timeFrame: At the end of 3-week treatment period
measure: Evaluation of the intake of rescue medications
timeFrame: From V1 (randomization) to V4 (Day 63 +/- 2 days)
Other outcomes:
Locations:
city: Siegen
country: Germany
facility: Diakonie Klinikum GmbH - Jung- Stilling Krankenhaus
state: Nordrhein-Westfalen
city: Hannover
country: Germany
facility: Klinikum Region Hannover (KRH) Klinikum Siloah
Study officials:
References: