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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Newcastle Clinical Trials Unit
+44 (0)191 208 2522
TALGiTS@newcastle.ac.uk


Mr James O'Hara
+44 (0)191 2137625
james.o'hara@newcastle.ac.uk


Mr James O'Hara
(+44) 0191 2137625
TALGiTS@newcastle.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Trial of alginates in throat symptoms
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Trial of alginates in throat symptoms

Recruiting

Open to: All Genders

Age: Adult

Newcastle upon Tyne Nottingham

Medical Conditions

Persistent throat symptoms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Persistent throat symptoms (PTS), including hoarse voice, sore throat, feeling of a lump in the throat, throat clearing, mucus going from the nose into the throat and/or catarrh (a build-up of mucus) are very common. At least 60,000 new patients are referred to NHS Ear Nose and Throat (ENT) and/or Speech and Language Therapy (SaLT) departments with PTS each year in the UK.

Specialists think that PTS can be linked to gastroesophageal reflux disease (GORD). GORD happens when the stomach contents (including stomach acid) frequently flow into the oesophagus (the food pipe) which connects the mouth to the stomach. This results in the lining of the oesophagus becoming irritated causing symptoms. The two main treatments for GORD are proton pump inhibitors (PPIs) (which reduce the amount of stomach acid) and liquid alginates (which form a barrier on top of stomach contents to prevent them from leaving the stomach and also act to make the stomach contents less harmful).

A previous trial (TOPPITS) looked at treating PTS with PPIs. This trial found that PPIs are not an effective treatment for PTS as they were only as good as a placebo (a dummy medicine) in treating PTS symptoms. The TALGiTS trial will look at whether liquid alginates are effective in the treatment of PTS. The liquid alginate used is Gaviscon Advance.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

26 May 2023 30 Apr 2025

Publications

2025 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39779273/ (added 10/01/2025)

ENT and SaLT department referral letters for patients presenting with PTS will be reviewed and potentially eligible patients approached for the trial. Participants will take part in the trial for 8 weeks while they are awaiting their routine appointment for their PTS. Participants will be randomised by computer to receive either Gaviscon Advance or a placebo medication (dummy drug), participants and local hospital staff will not know which treatment is allocated. There will be 5 contacts through the trial; one telephone consultation with a member of the trial team, three online questionnaires and one face-to-face clinic appointment.


Adults with PTS

You can take part if:



You may not be able to take part if:


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 screening3.2. 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 screening3.3. 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 screening4. Female participants with a known pregnancy5. 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 calculi6. 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 IMP8. Any current or prior head and neck or gastroesophageal malignancy9. 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 cervix10. Inability, in the opinion of the investigator, to be able to complete the clinical trial visits or procedures11. Any condition that, in the opinion of the investigator, would exclude the patient from participation in the trial


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Freeman Road Hospital
    Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • Queens Medical Centre Campus
    Derby Road
    Nottingham
    NG7 2UH

Due to the remote nature of the trial, there is the potential to miss any adverse events occurring. To minimise this, every 2 weeks participants will complete a self-report of any illnesses/side effects experienced and any new regular medication that they have started taking.
Participants will be supplied with a Safety Card with the contact details of the Chief Investigator on it, participants are advised to show this card to any care team they interact with to highlight their trial involvement.
The Head and Neck Risk Calculator will be used to determine the risk that patients presenting symptoms are potentially related to cancer. Patients identified as high risk will be excluded from the trial and diverted to standard care urgent referral. Patients meeting the moderate and low-risk criteria are eligible for the trial. For moderate risk, a week 6 appointment is recommended, by participating in the trial patients will be seen at 8 rather than 6 weeks. This is thought acceptable as in standard care the week 6 appointment is a recommendation rather than a target-driven requirement and is not likely routinely met. Trial participation ensures a week 8 appointment, which may be faster than standard care, and does not introduce additional risk for the small number of patients who may subsequently be diagnosed with cancer (estimated 0.9-3%).
As it's not known whether Gaviscon Advance is an effective treatment for persistent throat symptoms (PTS), it is also now known if the participants taking the placebo will experience PTS symptoms deteriorating or lasting longer than if taking the active medication. Use of a placebo is considered acceptable as in standard care no treatment would be given routinely while awaiting a consultation for PTS referral. The Patient Information Sheet (PIS) contains information on the chance of receiving a placebo.
The placebo for the trial is near matched rather than identical. A placebo for Gaviscon Advance that is gloopy, does not adhere to/protect oesophageal mucosa, and whose peppermint flavour does not reduce heartburn is a challenge. Reckitt has developed a placebo for Gaviscon Advance which is indistinguishable in appearance (colour, viscosity, opalescence), odour and taste, however, the mouthfeel is slightly different resulting in the placebo being near-matched rather than identical. Due to the trial's parallel design, remote delivery and the blinding used there is a very low risk that the small difference in mouth feel of the placebo will break the blind.
Gaviscon Advance and other alginate products are available to purchase over the counter and may be accessed/taken by trial participants in addition to their trial treatment. Over-the-counter alginate products will be concomitant medications for the trial, this is clearly indicated in the PIS.
Taking part in the trial will require a time commitment from participants. The trial will last for 8 weeks and has been designed to be delivered mostly in a remote format i.e. without the need for participants to regularly visit the trial hospital site. There are two telephone consultations and one face-to-face consultation with the site trial team scheduled over the 8 weeks. Additionally, participants will be asked to complete questionnaires online at 2, 4 and 6 weeks, these will be able to be completed at a time suitable for participants. Sites will be able to use any contact method, in line with their local policies and procedures, to contact participants remotely. For participants not able to, or not wishing to, complete follow-ups in the suggested format that the format be changed i.e. participants not wanting remote contact are able to attend in person.
Trial medication will be delivered to participants by courier in one shipment at the start of the trial and will contain all of the medication required for the 8 weeks of trial treatment. There is the risk that trial medication does not get received by the participant, e.g., they miss the courier. To prevent this the site trial team will communicate the expected delivery date with participants so that they know when to expect medication. Additionally, participants can nominate the address that they would like the medication delivered or nominate someone else in their household to receive medication on their behalf. If no one appropriate is available, the courier will return the medication to the central distribution centre and re-delivery attempted another day.
Trial medication is supplied in one 'kit' of multiple glass bottles. There is the risk that there may be damage to medication bottles either in transit or after participant receipt. To mitigate this risk, each medication kit includes additional medication that is needed for the 8 weeks of trial treatment.

Mr James O'Hara
(+44) 0191 2137625
TALGiTS@newcastle.ac.uk


Mr James O'Hara
+44 (0)191 2137625
james.o'hara@newcastle.ac.uk


Dr Newcastle Clinical Trials Unit
+44 (0)191 208 2522
TALGiTS@newcastle.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Newcastle upon Tyne Hospitals NHS Foundation Trust and funded by Reckitt Benckiser Pharmaceuticals.



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Read full details for Trial ID: ISRCTN13949559

Or CPMS 53492

Last updated 10 January 2025

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