DyspepsiaNCT03531372
Mipolixin® Compared to Poliprotect® in Moderate Functional Dyspepsia and Heartburn.
A study testing Mipolixin® and Poliprotect® in people with Dyspepsia and Heartburn, run by Aboca Spa Societa' Agricola at 11 sites in Spain.
Trial summary
Evaluation of the clinical efficacy of two medical devices, Mipolixin® and Poliprotect®, in improving the overall symptom severity of functional dyspesia and/or heartburn Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Mipolixin® and Poliprotect®
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 11 sitesSpain
- Study dates
- 24 Apr 2018to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent, preferably in writing or, failing that, orally in front of a witness, before any study procedure is performed.
- Male and female patients aged 18 to 75 years old (inclusive).
- Patients with symptoms of functional dyspepsia (according to the Rome IV criteria) of moderate severity (VAS score between 30 mm and 70 mm) and/or bothersome heartburn within 2 and 14 days prior to the screening/baseline visit.
- o According to the current Rome IV diagnostic criteria, functional dyspepsia is defined as one or more of the following symptoms: postprandial fullness (classified as postprandial distress syndrome), early satiation (inability to finish a normal sized meal, also classified as postprandial distress syndrome), and epigastric pain or burning (classified as epigastric pain syndrome).
- Ability of the patients (according to the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects.
- Patients who agree not to alter their diet in any way for the duration of the trial and to maintain it at steady state.
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- Patients who agree not to make any major lifestyle changes during the trial.
- Willingness to comply with all the study procedures and schedule.
- Chronic therapies (if not related to the gastroenterological pathologies object of the study, according to the opinion of the investigator) are allowed, if the regimen is maintained stable during the whole study.
Who cannot join
- Declines or unable to provide informed consent.
- Disease or health condition
- Patient presenting at least one of the following symptoms or conditions at screening: anemia, chronic gastrointestinal bleeding, progressive unintentional weight loss, epigastric mass, anorexia, persistent or recurrent vomiting, dysphagia or odynophagia, porphyria, hypophosphatemia, and/or cachexia.
- Patients presenting with at least of the following gastrointestinal conditions at screening: erosive GERD, Barrett's oesophagus or oesophageal stricture, active or healing gastroduodenal ulcer (except scars), history of gastric, duodenal or esophageal surgery, symptomatic gallstone, and/or other gastrointestinal disease such as gastroenteritis, inflammatory bowel disease, celiac disease and/or colorectal cancer.
- Patients with known malignancy disease, infectious disease or severe heart or pulmonary disease.
- Patients with known severe liver or kidney disease (AST/SGOT, ALT/SGPT >2 upper limits of normal, serum creatinine >1.5 mg/dl).
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- Patients with mental or metabolic disorders and any other disease that according to the physician can compromise the patient´s safety and/or patient´s study compliance.
- Treatments
- Patients receiving any treatment (pharmacological or medical device) for heartburn or dyspeptic symptoms within the last 14 days prior to randomization.
- Patients receiving any drugs that could affect symptoms or study evaluation such antacids, PPIs, H2RAs, prokinetics, and/or gastric mucosal protectants at baseline and/or taken within the last 14 days prior to randomization.
- Patients receiving any drugs that could affect symptoms or the study as antibiotics, NSAIDs, anticholinergics and/or cholinergic agents.
- Note: Patients will be asked to avoid any drugs of the above mentioned since the beginning of the study (baseline visit) until the end of the study.
- Patients under triple therapy or eradication therapy against Helicobacter pylori.
- Patients planned for long-term new therapies with anti-anxiety agents, glucocorticosteroids and anti-inflammatory agents during study period.
- Known hypersensitive or intolerance to any components of the study medical devices.
- Previous intake of any of the study medical devices.
- Other general conditions
- Patients who are unable to understand or are unwilling to sign an informed consent form.
- Unable or unwilling to complete all required screening and/or follow-up assessments.
- Unable to understand and complete self-administered scales/questionnaires planned to be used in the study.
- Participation in interventional research studies of investigational medicinal or device products (ongoing or terminated less than 30 days before screening)
- Patients with active alcohol or drug addiction or any other condition that, in the investigator's opinion, would interfere with their ability to comply with the study requirements.
- Patients with any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.
- Pregnant or nursing (lactating) women;
- Women of childbearing potential and sexually active: they must be willing to use at least one acceptable effective contraceptive measure (- progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action , - male or female condom with or without spermicide, - cap, diaphragm or sponge with spermicide). Pregnancy test will be performed at screening and at the final/premature withdrawal visit. The use of contraception in male patients is not required.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
CS Albuñol
Albuñol, 18700
CS Disset de Setembre
el Prat de Llobregat, 08820
CS Montesa
Madrid, 28006
CS Goya
Madrid, 28009
Primary Care Centre Eloy Gonzalo
Madrid, 28010
CS Comillas
Madrid, 28019
CS Baviera
Madrid, 28028
CS Las Americas
Parla, 28981
CS San Blas
Parla, 28981
CS Isabel II
Parla, 28982
Consultorio Local Perales de Tajuña
Perales de Tajuña, 28540
About this study
Official title: Efficacy and Safety of Mipolixin® Compared to Poliprotect ® in the Relief of Symptoms of Moderate Functional Dyspepsia and Heartburn: A Randomized, Double-blind, Parallel Group,Non-inferiority Clinical Study
Evaluation of the clinical efficacy of two medical devices, Mipolixin® and Poliprotect®, in improving the overall symptom severity of functional dyspesia and/or heartburn
- Being tested
- Mipolixin®, Poliprotect®
- Medical subject headings
- Dyspepsia, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mipolixin®Device
Also called Advanced Natural Antacid
1.55g chewable tablet 5 times a day for 2 weeks
Poliprotect®Device
Also called Neobianacid
1.55 g chewable tablet 5 times a day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mipolixin® | Experimental | Mipolixin® (Advanced Natural Antacid - AdNA) Receives: Device: Mipolixin® |
| Poliprotect® | Active comparator | Poliprotect® (Neobianacid) Receives: Device: Poliprotect® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall symptom severity from baseline (day 0) to day 14 between the two study arms
The primary endpoint is the change in the score of a visual analog scale (VAS) (from "no symptoms" to "overwhelming symptoms") used for evaluating overall symptom severity from baseline (day 0) to day 14 after treatment initiation, between the two study arms. A decrease in VAS score of at least 30% is considered as a clinically meaningful improvement, and therefore subjects achieving a decrease ≥30% in this scale will be considered as responders. The non-inferiority is considered demonstrated if the 95% confidence interval of the difference in the percentage of responders between both study arms lies within the non-inferior margin value defined of 20%.
Measured: Day 0 and Day 14
Secondary outcomes (8)
Responders from baseline to day 3 and day 7
Percentage of responder patients (VAS score decrease of at least 30%) on the basis of the mean change in the overall symptom severity assessed by the VAS score from baseline to day 3 and day 7 in both study arms
Measured: Day 0, Day 3 and Day 7
Self-assessment severity of individual specific symtoms
Comparison between Mipolixin® and Poliprotect® in the mean change of the score of the self-assessed severity of individual specific symtoms (bothersome postprandial fullness, bothersome early satiation, bothersome epigastric pain, bothersome epigastric burning, and bothersome heartburn) rated on a 100 mm VAS (from "no symptoms" to "overwhelming symptoms") from baseline to 1 3, 7 and 14 days after treatment initiation.
Measured: Day 0, Day 1, Day 3, Day 7 and Day 14
Change in the score of GOS scale from baseline to day 1
Change in the score of GOS ( Global Overall Symptom) scale from baseline to day 14 in both study arms. A decrease in GOS score ≥2 is considered as a clinically meaningful improvement, and therefore subjects achieving a decrease in overall severity score ≥2 from baseline in this scale will be considered as responders.
Measured: Day 0 and Day 14
Incidence of AEs during study treatment
Incidence and type of adverse events (AEs) and serious adverse events (SAEs) reported during study treatment.
Measured: Day 0 to Day 14
Incidence of AEs and clinical findings during study period
Safety will be assessed on the basis of all AEs experienced during study treatment and all observed and volunteered AEs and abnormal findings on physical examination, including vital signs throughout the study.
Measured: Day 0 to Day 28
Patient satisfaction (treatment administration)
Patient level of satisfaction in terms of treatment administration/posology will be assessed by means of specific questions about patient level of satisfaction after the 2-week treatment period. The response will be scored on a 4-point Likert scale from 0 to 4, as follows: 1 = "very satisfied", 2 = "quite satisfied", 3 = "somewhat satisfied", 4 = "not satisfied".
Measured: Day 3, Day 7 and Day 14
Patient satisfaction (taste)
Patient level of satisfaction in terms of chewable tablets taste will be assessed by means of specific questions about patient level of satisfaction after the 2-week treatment period. The response will be scored on a 4-point Likert scale from 0 to 4, as follows: 1 = "very satisfied", 2 = "quite satisfied", 3 = "somewhat satisfied", 4 = "not satisfied".
Measured: Day 3, Day 7 and Day 14
Treatment compliance
Treatment compliance will be evaluated by performing the IP accountability. This data will be corroborated with the information recorded in the patient diary concerning the daily administered and missed doses.
Measured: Day 0 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start24 Apr 2018
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aboca Spa Societa' Agricola
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- La Sociedad Española de Médicos de Atención Primaria, Dynamic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531372
- Sponsor's protocol ID
- ABO-NB-SEM-17
- Status last verified
- May 2021
- First submitted
- 9 May 2018
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Mipolixin® Compared to Poliprotect ® in the Relief of Symptoms of Moderate Functional Dyspepsia and Heartburn: A Randomized, Double-blind, Parallel Group,Non-inferiority Clinical Study
- ClinicalTrials.gov ID
- NCT03531372
- Acronym / sponsor ID
- ABO-NB-SEM-17
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Aboca Spa Societa' AgricolaIndustry (pharma, biotech, devices)
- Collaborators
- La Sociedad Española de Médicos de Atención Primaria, Dynamic
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the clinical efficacy of two medical devices, Mipolixin® and Poliprotect®, in improving the overall symptom severity of functional dyspesia and/or heartburn
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mipolixin® | Experimental | Device: Mipolixin®Mipolixin® (Advanced Natural Antacid - AdNA) |
| Poliprotect® | Active comparator | Device: Poliprotect®Poliprotect® (Neobianacid) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to provide informed consent, preferably in writing or, failing that, orally in front of a witness, before any study procedure is performed.
- Male and female patients aged 18 to 75 years old (inclusive).
- Patients with symptoms of functional dyspepsia (according to the Rome IV criteria) of moderate severity (VAS score between 30 mm and 70 mm) and/or bothersome heartburn within 2 and 14 days prior to the screening/baseline visit.
- o According to the current Rome IV diagnostic criteria, functional dyspepsia is defined as one or more of the following symptoms: postprandial fullness (classified as postprandial distress syndrome), early satiation (inability to finish a normal sized meal, also classified as postprandial distress syndrome), and epigastric pain or burning (classified as epigastric pain syndrome).
- Ability of the patients (according to the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects.
Key exclusion criteria (25 listed)
- Declines or unable to provide informed consent.
- Patient presenting at least one of the following symptoms or conditions at screening: anemia, chronic gastrointestinal bleeding, progressive unintentional weight loss, epigastric mass, anorexia, persistent or recurrent vomiting, dysphagia or odynophagia, porphyria, hypophosphatemia, and/or cachexia.
- Patients presenting with at least of the following gastrointestinal conditions at screening: erosive GERD, Barrett's oesophagus or oesophageal stricture, active or healing gastroduodenal ulcer (except scars), history of gastric, duodenal or esophageal surgery, symptomatic gallstone, and/or other gastrointestinal disease such as gastroenteritis, inflammatory bowel disease, celiac disease and/or colorectal cancer.
- Patients with known malignancy disease, infectious disease or severe heart or pulmonary disease.
- Patients with known severe liver or kidney disease (AST/SGOT, ALT/SGPT >2 upper limits of normal, serum creatinine >1.5 mg/dl).
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 |
|---|---|---|
| Mipolixin®Also: Advanced Natural Antacid1.55g chewable tablet 5 times a day for 2 weeks | Device | Mipolixin® |
| Poliprotect®Also: Neobianacid1.55 g chewable tablet 5 times a day for 2 weeks | Device | Poliprotect® |
Primary outcome
Change in overall symptom severity from baseline (day 0) to day 14 between the two study arms
Time frame: Day 0 and Day 14
The primary endpoint is the change in the score of a visual analog scale (VAS) (from "no symptoms" to "overwhelming symptoms") used for evaluating overall symptom severity from baseline (day 0) to day 14 after treatment initiation, between the two study arms. A decrease in VAS score of at least 30% is considered as a clinically meaningful improvement, and therefore subjects achieving a decrease ≥30% in this scale will be considered as responders. The non-inferiority is considered demonstrated if the 95% confidence interval of the difference in the percentage of responders between both study arms lies within the non-inferior margin value defined of 20%.
8 secondary outcomes
Responders from baseline to day 3 and day 7
Time frame: Day 0, Day 3 and Day 7
Self-assessment severity of individual specific symtoms
Time frame: Day 0, Day 1, Day 3, Day 7 and Day 14
Change in the score of GOS scale from baseline to day 1
Time frame: Day 0 and Day 14
Incidence of AEs during study treatment
Time frame: Day 0 to Day 14
Incidence of AEs and clinical findings during study period
Time frame: Day 0 to Day 28
Patient satisfaction (treatment administration)
Time frame: Day 3, Day 7 and Day 14
Patient satisfaction (taste)
Time frame: Day 3, Day 7 and Day 14
Treatment compliance
Time frame: Day 0 to Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mipolixin® and Poliprotect® in people with Dyspepsia and Heartburn, run by Aboca Spa Societa' Agricola at 11 sites in Spain.
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 9 inclusion and 25 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 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in overall symptom severity from baseline (day 0) to day 14 between the two study arms (time frame: Day 0 and Day 14). 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 26 May 2021.