Comparison of the effect of baclofen and proton pump inhibitors in patients with gastroesophageal reflux disease

Comparison of the effectiveness of proton pump inhibitor (PPI) alone and with the method of adding baclofen to proton pump inhibitor (PPI) in the treatment of patients with gastroesophageal reflux disease (GERD) aged 7 to 12 years

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210308050634N1

Enrollment

Registered

2021-06-12

Start date

2021-05-24

Completion date

Unknown

Last updated

2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastroesophageal reflux disease. Gastro-esophageal reflux disease

Interventions

Intervention 1: Intervention group: Intervention group: An omeprazole group with a dose of 1 mg per kg body weight and baclofen 0.15 mg per kg body weight when patients are monitored. Received therape

Eligibility

Sex/Gender

All

Age

7 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children 7-12 years with gastroesophageal reflux disease

Exclusion criteria

Exclusion criteria: Cases of specific diseases (cerebral palsy, treated with anticonvulsant drugs, patients with gastrointestinal ulcers and IBD)

Design outcomes

Primary

Measure	Time frame
Voice violence or difficulty speaking. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire.;Heartburn or chest pain or sourness. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire.;Clear the throat. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire.;Coughing after eating or lying down. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire.;Night cough. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire.;Shortness of breath or suffocation. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire.;Feeling of a lump in the throat that is not relieved by eating. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire.;Sputum in the throat. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire.;Hard swallowing of liquids and solids. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire.	—

Measure

Time frame

Voice violence or difficulty speaking. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire.;Heartburn or chest pain or sourness. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire.;Clear the throat. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire.;Coughing after eating or lying down. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire.;Night cough. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire.;Shortness of breath or suffocation. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire.;Feeling of a lump in the throat that is not relieved by eating. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire.;Sputum in the throat. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire.;Hard swallowing of liquids and solids. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Reflux Questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. vajih Modarresi

Islamic Azad University

drmodarressi@gmail.com+98 35 3725 1830

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026