NCT01969214

Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea

Open Label Study to Assess the Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: InQpharm Group · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Diosmectite in IQP-MM-101 has been used for diarrhoea control. Backed by data from several studies demonstrating their efficacy, the investigators are conducting this study to look into the efficacy and safety of IQP-MM-101 in diarrhoea control.

Detailed description

The clinical study was intended to evaluate the safety and the potential reduction of diarrhoea recovery time post 1st intake of IQP-MM-101 in an open label, single arm, multicentre study over a 72 hours period. There were 2 clinic visits: the screening visit and final visit. At baseline visit (visit 1), written informed consents were collected. Each patients were given a diary and the following data were collected: demographics, vital signs, physical examination results, use of concomitant medication, previous medical history, and case history of the acute diarrhoea episode including date of first watery stool, number of stools over the past 24 hours, and presence of other associated symptoms over the past 24 hours (nausea, vomiting, abdominal pain). Subjects recorded the following data in the diary: date and hour of bowel movement, stool consistency (Bristol stool scale) presence of symptoms such as nausea, vomiting, abdominal pain and study IP consumption (number, date, and time of tablets taken) and time of vomiting (if any) each day during the treatment period. Additionally, subjects recorded the time absent from work and a subjective evaluation of their "energy for everyday life". Visit 2 took place after 72 hours treatment period. Following data was collected: * Vital signs, physical examination * Adverse events * Use of concomitant medication * Compliance (returned IP and diary) * Global evaluation of efficacy and safety by subjects and investigators During the 72-hour treatment period, all subjects were instructed to consumed IQP-MM-101 according to the following dosage: one (1) tablet, three (3) times a day dissolved in at least 125mL (half a glass) of water.

Conditions

• Diarrhoea

Interventions

Type	Name	Description
DEVICE	IQP-MM-101	Dissolve the effervescent tablets in half a glass of water, to be taken orally 1 tablet, 3 times a day

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2013-10-25
• Last updated: 2020-03-04
• Results posted: 2020-03-04

Locations

1 site across 1 country: Germany