Gastro-oesophageal reflux disease (GORD) Digestive System
Conditions
Interventions
Participants will be randomised into two trial arms:
1. Alginate + lifestyle consultation
2. Omeprazole
A randomisation schedule generated in SAS version 9.4 will be used to randomise subjects.
Tria
Sponsors
Reckitt Benckiser Health Limited ("Reckitt”)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 13/04/2026: 1. Participant has provided written informed consent and is able to comply with all study restrictions 2. Participant is male or female and aged 18 to 70 years old 3. A 1-week screening window in which: the daily HRDQ score is >0.7 on =3 days; no more than 2 days total with a severe score reported in either heartburn or regurgitation symptoms*; and no more than a mild score reported in dyspepsia symptoms at any point during the screening window. This will be assessed with a 7-day collection of HRDQ where participants must complete a minimum of 6 days of data collection. * Severe cannot be recorded on more than 2 days for heartburn or regurgitation combined. 4. Participants of childbearing potential* must have a negative urine pregnancy test at screening and be willing to use an acceptable method of contraception throughout the study and for one menstrual cycle after last drug administration. In accordance with the Clinical Trial Facilitation Group (CTFG) recommendations, for the purpose of the study the following methods of contraception are acceptable: 4.1. Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or implantable) 4.2. Progestogen-only oral hormonal contraception (oral, injectable, or implantable) 4.3. Male or female condom with or without spermicide 4.4. Cap, diaphragm or sponge with spermicide 4.5. Intrauterine device (IUD) 4.6. Intrauterine hormone-releasing system (IUS) 4.7. Vasectomised partner (who has received medical assessment of the surgical success) 4.8. Bilateral tubal occlusion 4.9. Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments and must be the preferred and usual lifestyle of the participant) * For the purposes of this study, a participant is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. (Clinical Trials Facilitation Group, 2020 _____ Previous key inclusion criteria: 1. Participant has provided written informed consent and is able to comply with all study restrictions 2. Participant is male or female and aged 18 to 70 years old 3. Daily HRDQ score >0.7 on =3 days per week, a no greater than moderate score in either heartburn or regurgitation and no more than a mild score in dyspepsia. This will be assessed with a 7-day collection of HRDQ, where participants must complete a minimum of 6 days of data collection. 4. Participants of childbearing potential* must have a negative urine pregnancy test at screening and be willing to use an acceptable method of contraception throughout the study and for one menstrual cycle after last drug administration. In accordance with the Clinical Trial Facilitation Group (CTFG) recommendations, for the purpose of the study the following methods of contraception are acceptable: 4.1. Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or implantable) 4.2. Progestogen-only oral hormonal contraception (oral, injectable, or implantable) 4.3. Male or female condom with or without spermicide 4.4. Cap, diaphragm or sponge with spermicide 4.5. Intrauterine device (IUD) 4.6. Intrauterine hormone-releasing system (IUS) 4.7. Vasectomised partner (who has received medical assessment of the surgical success)
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 13/04/2026: 1. Female participant who is pregnant as confirmed by a positive pregnancy test (urine dipstick at screening) or is lactating 2. Participant has a current and previous clinically significant medical history as deemed by the Investigator, including but not limited to cardiovascular, respiratory, gastrointestinal, neurological, metabolic and psychiatric disorders 3. Participant with known Los Angeles (LA) grade C or D oesophagitis, previously demonstrated on endoscopic investigation 4. Participant with a previous or current diagnosis of Barrett’s oesophagus 5. Participant with previous evidence of neoplasia on gastroscopy confirmed via histology 6. Participant with red flag symptoms (i.e. dysphagia, unintentional weight loss, unexplained anaemia, abdominal mass) unless satisfactorily investigated 7. Participant with renal impairment 8. Participant has previously been prescribed any PPI for more than 28 consecutive days for any indication in the last 6 months or has previously been prescribed any PPI for more than 28 consecutive days for GORD symptoms historically. 9. Participant is currently taking any GLP-1 agonist medication (e.g. semaglutide) 10. Participant has a history of drug or alcohol abuse in the 2 years prior to screening, alcohol use disorders will be screened for using the AUDIT questionnaire 11. Participant has a contraindication to using the investigational products as per the product's SmPC 12. Participant has a known history of previous allergy/sensitivity to PPIs, calcium carbonate, sodium alginate, sodium bicarbonate, substituted benzimidazoles, any of the excipients contained within the investigational medicinal products (alginate and omeprazole) or the non-investigational medicinal product (i.e. lactulose, midazolam, lidocaine, and xylocaine) 13. Participant has received an investigational product or participated in another trial involving a marketed or investigational drug in the 90 days prior to first drug administration 14. Participant has previously been enrolled (randomised) into the current study 15. Participant who is an employee at the site or a partner or first-degree relative of the Investigator 16. Participant fails to satisfy the Investigator of fitness to participate for any other reason _____ Previous key exclusion criteria: 1. Female participant who is pregnant as confirmed by a positive pregnancy test (urine dipstick at screening) or is lactating 2. Participant has a current and previous clinically significant medical history as deemed by the Investigator, including but not limited to cardiovascular, respiratory, gastrointestinal, neurological, metabolic and psychiatric disorders 3. Participant with known Los Angeles (LA) grade C or D oesophagitis, previously demonstrated on endoscopic investigation 4. Participant with a previous or current diagnosis of Barrett’s oesophagus 5. Participant with previous evidence of neoplasia on gastroscopy confirmed via histology 6. Participant with red flag symptoms (i.e. dysphagia, unintentional weight loss, anaemia, abdominal mass) unless satisfactorily investigated 7. Participant with renal impairment 8. Participant has previously been prescribed any PPI for more than 14 days historically 9. Participant is currently taking any GLP-1 agonist medication (e.g. semaglutide) 10. Participant has a history of drug or alcohol abuse in the 2 years prior to screening, alcohol use disorders will be screened for using the AU
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reflux symptom severity measured using the Heartburn Reflux Dyspepsia Questionnaire (HRDQ) score from baseline to the end of treatment period 1 of the study (4 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reflux symptom severity measured using the Heartburn Reflux Dyspepsia Questionnaire (HRDQ) score from baseline to specified timepoints (1 week, 12 weeks, and 24 weeks) 2. Recorded time to onset action, measured by a time to relief question asked at the end of each day in week 1 in the patient diary 3. BMI measured using weighing scales with integrated height ruler from baseline visit (day 0) to end of study (24 weeks) 4. Waist measured using tape measure from baseline visit (day 0) to end of study (24 weeks) 5. Body composition (fat mass %) measured using bioelectric impedance analyser from baseline visit (day 0) to end of study (24 weeks) 6. Cigarette usage (cigarettes/week) measured using unvalidated weekly retrospective lifestyle questionnaire from baseline visit (day 0) to end of study (24 weeks) 7. Alcohol intake (units/week) measured using an unvalidated weekly retrospective lifestyle questionnaire from baseline visit (day 0) to end of study (24 weeks) 8. Blood pressure measured using a sphygmomanometer from baseline visit (day 0) to end of study (24 weeks) 9. Lipid profile determined by assessment of serum cholesterol from baseline visit (day 0) to end of study (24 weeks) 10. Quality of life measured by GERD Health-Related Quality of Life (GERD-HRQL) score from baseline visit (day 0) to end of study visit (24 weeks) 11. Abdominal symptoms measured by Gastrointestinal Symptom Rating Scale (GSRS) from baseline visit (day 0) to end of study visit (24 weeks) 12. Number of participants in the PPI arm who had to reinitiate PPI therapy, assessed by the reinitiation which will be captured in the eCRF between 5 weeks and 24 weeks 13. Number of PRN doses taken in the second treatment window by the Alginate Arm, measured via patient diary at 5 weeks and 24 weeks 14. The number and type of Adverse Events (AE) reported at any visit either spontaneously by the participant or in response to non-leading questioning; at any time by the patient using the patient diary; at | — |
Countries
England, United Kingdom
Outcome results
None listed