Gastricel-I

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.

Scientific title:

Evaluation of the effect and safety of Microcrystalline Cellulose Suspension (Gastricel®) in patients with alkaline gastritis due to duodenogastric reflux

Secondary indentifying numbers:

EC00118

Issuing authority of the secondary identifying numbers:

Center for Pharmaceutical Research and Development, Havana, Cuba.

Source(s) of monetary or material support:

Ministry of Public Health (MINSAP)

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:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

Pending to present. The protocol is in evaluation by Ethics Committee

Principal investigator

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

First name:

Felipe

Midle name:

Neri

Last name:

Piñol Jimenez

Medical Specialty :

Medical doctor. Second grade specialist in Gastroenterology. Professor and Senior Researcher.

Affiliation:

National Center for Minimally Invasive Surgery

Postal address:

Parraga 215 b/ San Mariano and Vista Alegre, La Vibora, Diez de Octubre.

City:

Havana

País:

Cuba

Zip Code:

10500

Telephone:

+53-776495332

Email address:

fpinol3@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:

Not applicable

Research ethics committees:

National Center for Minimally Invasive Surgery, in evaluation

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

03/09/2018

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:

Alkaline gastritis due to duodenogastric reflux

Health condition(s) code:

Gastritis

Gastroenteritis

Stomach Diseases

Gastrointestinal Diseases

Digestive System Diseases

Duodenogastric Reflux

Duodenal Diseases

Intestinal Diseases

Health condition keyword:

Alkaline gastritis

Intervention(s):

Gastricel Group (Experimental): Orally, a dose of microcrystalline cellulose suspension, a 15 mL spoonful, three times a day, for three months. Sucralfate Group (Control): Orally, one dose of sucralfate, one spoonful of 15 mL, three times a day, for three months. The administration of both medications, ambulatory way, will be done away from meals to ensure their action.

Intervention code:

Sucralfate

Suspensions

Administration, Oral

Intervention keyword:

Microcrystalline cellulose in suspension

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):

1. Bilious vomiting (Present, Absent). Measurement time: at baseline and, at the end of months 1, 2 and 3. 2. Pyrosis (Present, Absent). Measurement time: at baseline and, at the end of months 1, 2 and 3. 3. Epigastralgia. (Present, Absent). Measurement time: at baseline and, at the end of months 1, 2 and 3. 4. Degree of Gastritis associated with bile reflux (It will be classified in Grade 0, I, II, III by an endoscopy. The endoscopic definition defined by the Sydney System will be applied). Measurement time: at baseline, at first month, and at 3 months.

Key secondary outcomes:

Ingles 1- Degree of gastritis associated with bile reflux (It will be classified in Grade 0, I, II, III. The morphological descriptions of the Sydney System for measurable variables: inflammation, activity, atrophy and intestinal metaplasia, will be used). Measurement time: at baseline and, 3 months. 2- Presence of adverse events-AE (distribution frequency for the appearance of AE (Yes, No), type of event (name of the AE), duration (time from appearance until stop the event), severity (severe, non-severe), intensity of AE (grades 1-5), relation of causality (remote, possible, probable, very probable), result of AE (recuperate, improvement, persist or sequels), attitude concerning the studied treatment (without changes, dose modification, temporal or definitive treatment discontinuation)). Measuring time: At each administration until end 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:

18 years

Maximum age:

70 years

Inclusion criteria:

1- Patients with chronic alkaline gastritis due to duodenogastric reflux, diagnosed by clinical and endoscopic study and gastric biopsy. 2- Patients with bile reflux with intact or operated stomach, or patients with intact stomach but who have been surgically removed from the gallbladder. 3- Presence of one or more symptoms of the following: epigastralgia, pyrosis, vomiting (bilious or not). 4- Hematological and biochemical studies within the established ranges. 5-Written informed consent of the patient to participate in the investigation and to complete the established examinations.

Exclusion criteria:

1- Pregnancy, breastfeeding or puerperium. 2- Helicobacter pylori positive demonstrated by the method of urease and/or biopsy. 3- Patients with known chronic evolutive liver diseases that could alter the production in quantity or quality of bile acids. 4- Malabsorption syndrome produced by any etiology that could influence the excretion of bile acids. 5- Presence of duodenogastric reflux of haematic appearance in the endoscopy prior to inclusion in the study. 6- Malignant disease. 7- History of allergy or hypersensitivity to any component of the formulation. 8- Severe psychiatric disorder or mental incapacity.

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:

200

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:

Idrian

Last Name:

Garcia Garcia

Specialty:

PhD in Health Sciences. Bachelor in Pharmaceutical Sciences. Master in Experimental Pharmacology. Principal researcher.

Affiliation:

Center for Pharmaceutical Research and Development (CIDEM)

Postal Address:

Ave. 26 and Calzada de Grandes Puentes, # 1605, Plaza de la Revolucion.

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+53-78811944 ext. 143

Email :

idrian.garcia@cidem.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:

Idrian

Last Name:

Garcia Garcia

Specialty:

PhD in Health Sciences. Bachelor in Pharmaceutical Sciences. Master in Experimental Pharmacology. Principal researcher.

Affiliation:

Center for Pharmaceutical Research and Development (CIDEM)

Postal Address:

Ave. 26 and Calzada de Grandes Puentes, # 1605, Plaza de la Revolución.

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+53-78811944 ext. 143

Email :

idrian.garcia@cidem.cu

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:

RPCEC00000273

Date of Registration in Primary Registry:

18/05/2018

Record Verification Date:

2020/12/21

Next update date:

2021/12/21

Link to the spanish version:

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Ensayos Registrados

Proceso de Registro

Gastricel-I

Acerca del RPCEC

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