Safety Evaluation of Almagate in Pregnant Women with Gastroesophageal Reflux Disease: Impact on Perinatal Outcomes

Trial ID: 2024-515381-14-00
Protocol: M-00ALM-04
Sponsor: Almirall S.A.

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Diseases & Conditions

Gastrooesophageal reflux disease Dyspepsia

Objectives

The primary objective of this study is to assess the **safety** of almagate in pregnant women experiencing **heartburn** and **reflux**, as well as to evaluate the perinatal outcomes in the fetus and newborn. This is clinically relevant as it addresses the potential risks and benefits of using almagate during pregnancy, ensuring maternal comfort while safeguarding fetal and neonatal health.

Secondary objectives include:

Assessing the percentage of relevant events during delivery and the immediate postpartum period, as well as the development and neurodevelopment of the newborn up to 24 months of age.
Evaluating the efficacy of almagate in reducing heartburn and reflux in pregnant women.
Assessing patient satisfaction with treatment using almagate.

Participants

The clinical trial focuses on assessing the safety of **almagate** in pregnant women experiencing **heartburn** and **reflux**, as well as evaluating perinatal outcomes in the fetus and newborn. The study population comprises adult pregnant women aged 18 to 45 years, exclusively female, with no male participants involved. The trial specifically targets a vulnerable population, given the inclusion of pregnant women. Participants were selected based on the presence of heartburn, a common condition during pregnancy. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. The study does not include any male subjects, and the selection criteria emphasize the inclusion of pregnant women within the specified age range who are experiencing heartburn.

Plans and Procedures

The clinical trial is a **Phase IV**, multicenter, open-label, single-arm study designed to evaluate the safety of **almagate** in pregnant women experiencing heartburn and reflux, as well as to assess perinatal outcomes in the fetus and newborn. The trial is expected to commence recruitment on November 1, 2024, and conclude by November 1, 2026. Participants will be involved in the study for a maximum treatment period of 14 days, with the **almagate** administered as an oral suspension. The study will include adult pregnant women aged 18-45 years who are experiencing heartburn, with no specific exclusion criteria provided.

The trial will consist of several key visits: an initial inclusion (screening) visit, multiple follow-up visits, and an end-of-study visit. During the inclusion visit, eligibility will be confirmed, and baseline data will be collected. Follow-up visits will monitor the safety and efficacy of **almagate**, with assessments including gestational diabetes, hypertensive states of pregnancy, and the efficacy of **almagate** as an antacid. The delivery visit will focus on perinatal outcomes, such as abruptio placentae, immediate postpartum hemorrhage, and perinatal mortality. The end-of-study visit will conclude the participant's involvement, with a comprehensive evaluation of maternal and newborn health outcomes.

Participants may be withdrawn from the study if they experience adverse events that necessitate discontinuation of treatment, or if they fail to adhere to the study protocol. The primary endpoints include the collection of data on gestational diabetes, hypertensive states, and perinatal outcomes, while secondary endpoints will assess delivery type, newborn characteristics, and patient satisfaction with **almagate**. The study aims to provide valuable insights into the safety profile of **almagate** during pregnancy and its impact on both maternal and neonatal health.

Treatment

The clinical trial involves the administration of **Almagate**, marketed under the name Almax Forte 1.5 g oral suspension. This experimental medication is formulated as an oral suspension and is intended for the treatment of heartburn and reflux in pregnant women. The active substance, **almagate**, is of chemical origin and is classified under the ATC code A02AD03. The medication is administered orally, with a maximum daily dose of 8 grams and a total maximum dose of 112 grams over a treatment period of 14 days. The pharmaceutical form is specifically designed for oral administration, ensuring ease of use and compliance among participants.

In this study, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are utilized. The focus is solely on evaluating the safety profile of almagate in the specified patient population. Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the prescribed regimen. The trial is conducted in an open-label, single-arm format, allowing for direct observation of the effects of the medication on both maternal and perinatal outcomes.

Efficacy

The efficacy of **almagate** in the clinical trial will be assessed through various parameters, focusing on its use as an antacid in pregnant women experiencing heartburn and reflux. The primary endpoints include the evaluation of perinatal outcomes such as gestational diabetes, hypertensive states of pregnancy, abruptio placentae, immediate postpartum hemorrhage, perinatal mortality, maternal mortality, and low birth weight. These data will be collected at baseline, follow-up visits, and the delivery visit.

Secondary endpoints will involve assessing the type of delivery, birthing start, weight and length of the newborn, gestational age at delivery, and the APGAR score of the newborn. Additionally, a comprehensive physical examination will be conducted, and the total score of the ASQ-3™ questionnaire will be evaluated at 24 months of age. The efficacy of almagate as an antacid will be assessed at each follow-up visit based on the general impression of both the physician and the patient, classifying the experience as "very good," "good," "acceptable," "poor," or "very poor." Patient satisfaction will also be measured using a Likert scale, ranging from "completely disagree" to "completely agree" with the statement regarding satisfaction with almagate use.

Inclusion and Exclusion Criteria

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Inclusion Criteria

Adult pregnant women (age 18-45 years) with heartburn.

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Exclusion Criteria

Risk pregnancy. A high-risk pregnancy is defined as one that meets any of the following criteria: - Morbid obesity (BMI ≥ 40) - History of miscarriage (two or more previous miscarriages not performed voluntarily) - History of cervical insufficiency (history of the cervix's inability to carry a pregnancy to term) - Previous chromosomal abnormality (inherited fetal abnormalities) - Previous ectopic pregnancy - Previous gestational trophoblastic disease - Previous premature birth - Endocrinopathies (disorders of the endocrine gland, for example, hyper/hypothyroidism, prolactinoma, adrenal gland disorders) - Cardiovascular risk (WHO class III) - Twin pregnancy - Maternal infection diagnosed during pregnancy - Rh (D) isoimmunization and others - Current severe mental illness (psychotic disorders that occur continuously or episodically during pregnancy) two years or older). - Severe anemia (hemoglobin levels below 9 g/dL or hematocrit below 25%) - Suspected fetal malformation and/or fetal genetic/chromosomal abnormality.- - History of perinatal death. - Alcohol or other drug dependence. - Multiple gestations with three or more fetuses. - Threatened preterm labor. - Premature rupture of membranes.
Presence of undiagnosed gastrointestinal or rectal bleeding, severe hemorrhoidal syndrome*, or chronic digestive diseases accompanied by persistent pre-gestational diarrhea. *Severe hemorrhoidal syndrome is defined as: characterized by the presence of hemorrhoids in an advanced stage with intense symptoms and associated complications: - Intense and persistent pain, especially if there is hemorrhoidal thrombosis. - Heavy, intermittent, or constant bleeding, which can lead to anemia. - Irreducible hemorrhoidal prolapse, that is, when the hemorrhoids remain permanently outside the anus and cannot be manually reduced. - Thrombosis or ulceration, which can lead to increased inflammation, infection, and necrosis in severe cases. - Significant impact on quality of life, with difficulty sitting, defecating, or performing daily activities. - In these cases, medical treatment is usually insufficient, and surgery is considered the main option, such as hemorrhoidectomy or less invasive techniques such as rubber band ligation or transanal hemorrhoidal dearterialization (THD).
Other circumstances or difficulties that, in the researcher's judgment, may increase the risk to the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study.
Patient unable to give consent, or patient of consenting age but under guardianship, or vulnerable patients.
Patients must be in the first trimester of pregnancy; those eligible cannot be included until week 13+0 of pregnancy (all pregnancies before or at 13.0 weeks of gestation are excluded). Pregnancy is dated by measuring the CRL distance in the first trimester or, failing that, by the date of the last menstrual period.
Being participating or having participated in another clinical trial in the 6 months prior to the inclusion in this study.
Prior treatment with medications: antacids (except Almax), proton pump inhibitors (PPIs) or anti-histamine 2 blockers (anti-H2) during this pregnancy.
Hypersensitivity to almagate or any of its excipients
Patients with Alzheimer's disease.
Patients with diagnosed pre-gestational hypertension (HTN>140/90).
Patients with eclampsia and preeclampsia
Patients with pregestational diabetes mellitus or poorly controlled or corrected gestational diabetes with diet and insulin
Lack of informed consent.
criteria for discontinuation and premature withdrawal