NCT02619747

Compound Sodium Alginate Oral Suspension Sachet 4-hour Esophageal pH Study in GERD Patients

A Multi-centre, Randomised, Open Label, Placebo-controlled, Two-period Crossover Study to Evaluate 4-hour Esophageal pH Change in GERD Patients After Administration of Compound Sodium Alginate Oral Suspension Sachets or Placebo Sachets

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Reckitt Benckiser Healthcare (UK) Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Multi-centre, randomised, open-label, placebo-controlled, two-period crossover study of 4 hour pH monitoring following a refluxogenic meal and drink.

Detailed description

This is a multi-centre, randomised, open-label, placebo-controlled, two-period crossover study. After signing a written informed consent (ICF), patients will undergo a screening period of up to 10 days (Visit 1) which will require the patient to return to the clinic on several occasions. At the start of the screening process patients will have 24 hour (h) pH monitoring which will include one standardised refluxogenic meal after a 4 h fast. The 24 h pH monitoring results will be used as a key criteria for patient eligibility and to provide the patients with diagnostic information on their symptoms. After 24 h pH monitoring, eligible patients will be supplied with Compound Sodium Alginate Oral Suspension sachet to take as required for symptom relief between visits (up to 2×10ml sachets four times daily: 30 minutes after breakfast, 30 minutes after lunch, 30 minutes after dinner and immediately before lying down for bed, stopping dosing at least 24 hours prior to Visit 2). Patients who satisfy the study entry requirements within 10 days of consent, will be randomised to receive either two Compound Sodium Alginate Oral Suspension sachets (2×10ml) or two placebo sachets (2×10ml) following placement of a pH electrode after a 4 h fast and a standardised refluxogenic meal at Visit 2. Upon completion of the Visit 2 4-hour post-dose pH monitoring period patients will be re-supplied with Compound Sodium Alginate Oral Suspension sachets to take as required for symptom relief (up to 2×10ml sachets four times daily: 30 minutes after breakfast, 30 minutes after lunch, 30 minutes after dinner and immediately before lying down for bed, stopping dosing at least 24 hours prior to Visit 3) for 7 ± 2 days. Patients will return for Visit 3 after 7 ± 2 days. Visit 3 will consist of repeat pH catheter insertion (4 hour fast followed by refluxogenic test meal consumption) and pH monitoring, receiving the alternative randomised treatment at Visit 3.

Conditions

• Gastro-esophageal Reflux Disease (GERD)

Interventions

Type	Name	Description
DRUG	Compound Sodium Alginate Oral Suspension sachet
DRUG	Matched placebo

Timeline

• Start date: 2014-04-01
• Primary completion: 2017-03-31
• Completion: 2017-03-31
• First posted: 2015-12-02
• Last updated: 2017-10-06

Locations

1 site across 1 country: China