Gastro-oesophageal Reflux Disease Trial, Recruiting NCT06984484 Sponsor: Devintec Sagl Condition: Gastro-oesophageal Reflux Disease
Back to Gord

Gastro-oesophageal Reflux Disease Trial, Recruiting

NCT06984484
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults between 18 and 75 years old (male or female)
  • People experiencing ongoing heartburn and/or regurgitation (with or without stomach pain or burning) that is at least mild to moderate in severity, or that has occurred during the 7 days before the start of the study, as assessed by the study doctor
  • People who have not taken acid-reducing medications (such as PPIs or H2 blockers) or heartburn treatments (such as antacids, alginates, or similar products) in the week before the screening visit
  • People who are able to understand and follow the study procedures
  • People who have given written consent after being informed about the study procedures and risks
  • Women who could become pregnant must have a negative pregnancy test at the first visit and must use a reliable form of contraception throughout the study (confirm with trial site for which methods are accepted)

Who may not be able to join:

  • People who are allergic or sensitive to any ingredient in Afluxin® or the inactive control product
  • People who have rhinosinusitis (sinus infection/inflammation) or bronchitis
  • People with a history of, symptoms of, or findings on internal camera examination (endoscopy) suggesting: any other digestive tract disease, severe acid reflux with damage to the food pipe, Barrett's oesophagus, active stomach ulcer or ulcer complications, a hiatus hernia larger than 3 cm, Zollinger-Ellison syndrome, cancer of the food pipe or stomach, a narrowing of the stomach outlet (pyloric stenosis), previous surgery on the food pipe or stomach, bowel blockage, current pernicious anaemia, a need for H. pylori eradication treatment, or known digestive tract bleeding in the past 12 months
  • People diagnosed with a type of functional stomach disorder causing bothersome fullness after meals or feeling full very quickly (postprandial distress syndrome)
  • People who have had surgery on the stomach or food pipe, anti-reflux procedures, or weight-loss (bariatric) surgery
  • People with any active cancer, except certain non-invasive skin cancers (confirm with trial site)
  • People who have used any of the following medications in the week before screening: gut motility drugs (prokinetics), systemic steroid medications, or anti-inflammatory pain medications (NSAIDs)
  • People who are pregnant or breastfeeding
  • People who have taken part in another clinical trial within the 30 days before screening
  • People with significant or unstable other health conditions that the study doctor determines could interfere with participation or the study results

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +39 3334828012

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Devintec Sagl
Registry
ClinicalTrials.gov
Start date
2 July 2025
Est. completion
1 June 2026

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Assess the superiority of a 7-day treatment course with Afluxin® over inactive control in terms of difference between treatment groups in terms of proportion of responders

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov