Trial of alginates in throat symptoms

Not Applicable

• Conditions: Persistent throat symptoms; Ear, Nose and Throat

• Registration Number: ISRCTN13949559
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-04
• Last Update Posted: 20 June 2023
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Aged 18 years old and over
2. = 6-week history of persistent throat symptoms (hoarse voice, lump in throat sensation, throat clearing, cough, post-nasal secretions/catarrh, throat discomfort) as evidenced by a total RSI score omitting the ninth item (heartburn symptoms [HB] heartburn, chest pain, indigestion or stomach acid coming up” – i.e., RSI – HB) = 13
3. Ability to comprehend trial information and complete trial questionnaires
4. Willing and able to provide informed consent prior to any trial procedures taking place

Exclusion Criteria

1. Any symptoms that meet the NICE guidance for a two-week wait for suspected head and neck cancer referral, i.e., persistent unexplained hoarseness or unexplained neck lump.
2. Any symptoms that when entered into the head and neck cancer risk calculator (ORLHealth.com | HaNC-RC v2, 2019) lead to a recommended urgent suspected cancer referral
3. Prior to the screening, intake of:
3.1. Systemic glucocorticosteroids within 28 days of screening
3.2. Prokinetics (e.g., cisapride) or drugs with prokinetic function, such as macrolide antibiotics, during the preceding 5 days and initiated in the previous 2 weeks of screening
3.3. Anticholinergic drugs, sucralfate or any other drugs that in the investigator’s opinion may affect the baseline measurements for the patient within 7 days of screening
4. Female participants with a known pregnancy
5. Known chronic kidney diseases. Patients with a history of chronic kidney disease will be specifically asked about: reduced kidney function, controlled potassium diet, hypophosphatemia, phenylketonuria, hypercalcaemia, nephrocalcinosis, recurrent calcium containing renal calculi
6. Patients with known or suspected hypersensitivity to the active substances (sodium alginate, potassium hydrogen carbonate), or active substance excipients (methyl parahydroxybenzoate (E128), propyl parahydroxybenzoate (E216), sodium hydroxide, saccharin sodium, carbomer, calcium carbonate) or placebo excipient ingredients (hydrogenated glucose syrup, xanthan gum, titanium dioxide, caramel)
7. Administration of an Investigational Medicinal Product within 30 days of the first dose of IMP
8. Any current or prior head and neck or gastroesophageal malignancy
9. Current or prior malignancy not in complete remission within 3 years of screening with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix
10. Inability, in the opinion of the investigator, to be able to complete the clinical trial visits or procedures
11. Any condition that, in the opinion of the investigator, would exclude the patient from participation in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified