A Phase IV, Multicenter, Open-label, Single-arm Study to Evaluate the Safety of Almagate in Pregnant Women With Heartburn and Reflux, and Perinatal Outcomes in the Foetus and Newborn.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Almirall S.A.

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Stomatognathic Diseases [C07]

Trial duration

20 Nov 2024 → ongoing

Decision date (initial)

2024-10-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Almirall

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

The primary objective of this study is to assess the safety of almagate in pregnant women with heartburn and reflux and the perinatal outcomes in the foetus and newborn.

Secondary objectives 3

1. To assess the percentage of relevant events in the delivery and immediate postpartum (puerperium), and development/neurodevelopment of the newborn up to 24 months of age.
2. To evaluate the efficacy of almagate in reducing heartburn and reflux in pregnant women.
3. To assess patient satisfaction with treatment with almagate.

Conditions and MedDRA coding

heartburn and or reflux

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

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

Exclusion criteria 14

1. 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.
2. 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).
3. 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.
4. Patient unable to give consent, or patient of consenting age but under guardianship, or vulnerable patients.
5. 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.
6. Being participating or having participated in another clinical trial in the 6 months prior to the inclusion in this study.
7. Prior treatment with medications: antacids (except Almax), proton pump inhibitors (PPIs) or anti-histamine 2 blockers (anti-H2) during this pregnancy.
8. Hypersensitivity to almagate or any of its excipients
9. Patients with Alzheimer's disease.
10. Patients with diagnosed pre-gestational hypertension (HTN>140/90).
11. Patients with eclampsia and preeclampsia
12. Patients with pregestational diabetes mellitus or poorly controlled or corrected gestational diabetes with diet and insulin
13. Lack of informed consent.
14. criteria for discontinuation and premature withdrawal

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 7

1. Data collected at baseline and follow-up visits: Gestational diabetes
2. Data collected at baseline and follow-up visits: Hypertensive states of pregnancy (Gestational hypertension (HT), Pre-eclampsia, Eclamps)ia
3. Data collected at the delivery visit: Abruptio placentae
4. Data collected at the delivery visit: Immediate postpartum haemorrhage
5. Data collected at the delivery visit: Perinatal mortality (Foetal death, Neonatal mortality)
6. Data collected at the delivery visit: Maternal mortality
7. Data collected at the delivery visit: Low birth weight

Secondary endpoints 10

1. Type of delivery: Vaginal delivery, Instrumental, Caesarean section
2. Birthing start: Spontaneous , Induced, Planned Caesarean section
3. Weight and length of the newborn (NB)
4. Gestational age (GA) of NB at delivery: GA <37 weeks: pre-term NB, GA 37-42 weeks: full-term NB, GA >42 weeks: post-term NB
5. NB APGAR
6. Date of delivery: identification of pre-term, full-term, and post-term delivery.
7. Physical examination will include a complete head and neck examination, a cardiovascular, respiratory, abdominal and a complete neurological examination, including state of consciousness, motor system, primitive reflexes, osteotendinous reflexes, muscle tone, and sensitivity
8. The total score of the ASQ-3™ questionnaire taken at 24 months of age will be assessed, either as the score in each of the five different areas comprising this questionnaire: communication, gross motor, fine motor, problem solving and personal-social.
9. The efficacy of almagate as antacid will be assessed at each follow-up visit referring to each episode of heartburn/reflux by the general impression of the physician, on the one hand, and of the patient, on the other hand, classifying it as "very good", "good", "acceptable", "poor", "very poor" after the question "How would you classify your experience with the use of almagate for the treatment of heartburn/reflux?".
10. Patient satisfaction will be assessed at the follow-up visits through her response on the degree of agreement with the statement “I am satisfied with the use of almagate as antacid”, with 5 scoring options, from “completely disagree” to “completely agree” (Likert scale).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Almirall S.A.

Sponsor organisation

Almirall S.A.

Address

Ronda General Mitre 151

City

Barcelona

Postcode

08022

Country

Spain

Scientific contact point

Organisation

Almirall S.A.

Contact name

David David Asensio

Public contact point

Organisation

Almirall S.A.

Contact name

Cristina Serrano

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications