Abexol (suspension) versus Abexol (tablets) in patients with gastrointestinal symptoms

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

ASAT

Scientific title:

Study of the efficacy, safety and tolerability of Abexol (suspension) versus Abexol (tablets) in patients with gastrointestinal symptoms

Acronym of Scientific Title:

ASATSG

Secondary indentifying numbers:

AbeS/AbeT-01

Issuing authority of the secondary identifying numbers:

National Centre for Scientific Research

Source(s) of monetary or material support:

National Centre for Scientific Research, Central Account for BioCubafarma

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Alfredo

Last name:

Hierro Gonzalez

Medical Specialty :

Second Degree Specialist in Gastroenterology

Affiliation:

Institute of Gastroenterology

Postal address:

25 street 503 / H e I Vedado, Plaza de La Revolucion

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-52701784

Email address:

alfredo.hierro@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

No procede

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

01/09/2021

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Gastrointestinal symptoms

Health condition(s) code:

Signs and Symptoms, Digestive

Digestive System Diseases

Intervention(s):

Control Group: Abexol (tablets) (50 mg): 1 tablet by oral route, three times a day, 30 minutes before breakfast, lunch and dinner for 8 weeks. Experimental Group: Abexol (suspension) (50 mg): 1 tablespoon (≈5 mL) by oral route, three times a day, 30 minutes before breakfast, lunch and dinner for 8 weeks.

Intervention code:

Dietary Supplements

Tablets

Suspensions

Administration, Oral

Intervention keyword:

Abexol

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

GSRS (Significant improvement in the GSRS survey score). The treatments will be considered effective if the improvement obtained at the end of the study is significantly different from the baseline level. The validated questionnaire called Gastrointestinal Symptom Rating Scale (GSRS) will be used, to discriminate digestive symptoms, which consists of 15 questions that are answered using a scale that ranges from 0-3 points: from not presenting symptoms (0) to suffering them in the most severe way. frequent and intense (3). The global score ranges from 0-45 points, the lower the better the patient's condition in terms of gastrointestinal symptoms). Measurement time: At baseline and 8 weeks.

Key secondary outcomes:

1. Symptoms of GSRS scale (Significant reduction in the intensity of symptoms) Measurement time: at baseline and the end of the 8 weeks of treatment. 2. Consumption of antacids (Yes, No. Significant reduction in the consumption of antacids). Measurement time: at the end of the 8 weeks of treatment. 3. Quality of life questionaire SF-36 (Improvement in the score. The SF-36 Questionnaire is made up of 36 questions (items) that assess both positive and negative health states. The questionnaire covers 8 scales, which represent the health concepts used most frequently in the main health questionnaires, as well as the aspects most related to the disease and its treatment. The 36 items of the instrument cover the following scales: Physical function, Physical role, Body pain, General health, Vitality, Social function, Emotional role and Mental health). Measurement time: at baseline and the end of the 8 weeks of treatment

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

70 years

Inclusion criteria:

Patients with non-erosive erythomatous gastritis, both sexes, aged between 19 and 70 years, with gastrointestinal symptoms such as: epigastralgia (abdominal pain localized in the epigastric region), heartburn, nausea, heartburn, flatulence, regurgitation, belching, abdominal distension, feeling of rapid satiety, vomiting, anorexia incomplete, emptying sensation, attend an outpatient consultation at the Institute of Gastroenterology and agree to participate in the study by signing the informed consent.

Exclusion criteria:

Patients with Confirmatory endoscopy of gastric, duodenal or esophageal ulcer. Organic lesions of the upper digestive tract that require specific treatment. Benign and malignant digestive neoplasms. Alarm symptoms (digestive bleeding, anemia, significant loss of body weight, progressive dysphagia, odynophagia, persistent vomiting, lymphadenopathy, palpation of abdominal mass). Active liver or kidney diseases. Other non-digestive neoplasms. Thyroid gland disorders. Irritable bowel syndrome. Pancreatic conditions (acute or acute chronic pancreatitis). Intra and extrahepatic bile duct disorders. Izchemic alterations. Glucose > 7 mmol / L, and ALT> 55 IU, and / or creatinine> 130 umol / L. Diastolic blood > 105 mm Hg. Patients with any other special condition that at the discretion of the doctor puts their health and life at risk during the study.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

3

Target sample size:

100

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Julio

Middle Name:

Cesar

Last Name:

Fernandez Travieso

Specialty:

PhD in Pharmaceutical Sciences

Affiliation:

Clinical Trials Unit, National Centre for Scientific Research

Postal Address:

25 Avenue and 158, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-59958136

Email :

julio.fernandez@cnic.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Julio

Middle Name:

César

Last Name:

Fernández Travieso

Specialty:

PhD in Pharmaceutical Sciences

Affiliation:

Clinical Trials Unit, National Centre for Scientific Research

Postal Address:

25 Avenue and 158, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-59958136

Email :

julio.fernandez@cnic.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Institute of Gastroenterology

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

20/04/2021

Postal address of Ethic Committee :

25 street 503 / H e I Vedado, Plaza de La Revolucion, Havana, ZC 10400, Cuba

Telephone:

+53-78325594

Correo electrónico:

diregastro@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

01/02/2022

Date of available results:

01/04/2022

Date of first publication:

01/06/2022

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000372

Date of Registration in Primary Registry:

22/05/2021

Record Verification Date:

2021/06/15

Next update date:

2022/06/15

Link to the spanish version:

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Abexol (suspension) versus Abexol (tablets) in patients with gastrointestinal symptoms

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