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

Diarrhoea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01969214
• Other study ID #: INQ/015213
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: July 2014

Study information

• Verified date: January 2018
• Source: InQpharm Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18 to 65 years

• Good general health

• Acute diarrhoea episode defined as at least three watery stools per 24 hours over a period of 48 hours or less

• Acute diarrhoea of presumed infectious origin

• Patients with usually normal bowel movements (defecations) before onset of diarrhoea, that is, at least three normal stools per week and three or less normal stools per day

• Negative pregnancy test (ß HCG-test) for women with child bearing potential

• Written informed consent is a prerequisite for subject enrollment

Exclusion Criteria:

• Known sensitivity to the ingredients of the device

• Fever >38,5?C

• Blood or pus in stools

• Dehydration requiring intravenous rehydration

• History of chronic diarrhoea (three or more loose or watery stools per day for at least 12 weeks, consecutive or not, in the preceding 12 months)

• Use of antidiarrhoeal agents over the month prior to baseline

• Diarrhoea possibly induced by antibiotics, laxative agents, thyroid hormones, or colchicine

• Irritable bowel syndrome

• Any other acute or chronic disease that could interfere with the evaluation of study device

• Females who are pregnant or lactating

• Subjects who have participated in another clinical trial in the 30 days before treatment period

• Inability to comply

• Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation

Related Conditions & MeSH terms

• Diarrhea
• Diarrhoea

Intervention

Device:
• IQP-MM-101
Dissolve the effervescent tablets in half a glass of water, to be taken orally 1 tablet, 3 times a day

Locations

Country	Name	City	State
Germany	analyze & realize GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
InQpharm Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (in Hours) Between the 1st Intake of IQP-MM-101 and First Formed or Hard Stool (Type 6 to 1) Followed by a Non Watery Stool (Type 6 to 1)	In essence the definition of recovery would be two consecutive non-watery stool (type 6 to 1) when stool before 1st intake of IQP-MM-101 is primarily watery (type 7).	96 hours
Secondary	Time (Hours) From the First Intake to the Last Watery Stool	The last watery stool was assumed as the first-non watery stool	96 hours
Secondary	Number of Daily Defecation		96 hours
Secondary	Number of Watery Stools		96 hours
Secondary	Stool Frequency	The mean number of daily defecation.	96 hours
Secondary	Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint)		72 hours
Secondary	Abdominal Pain	Subjects feeling of abdominal pain was measured on visual analog scale of 0 - 100mm (no pain to severe pain).	96 hours
Secondary	Time Off From Work		1 week
Secondary	Evaluation of Subjects' Energy Level	The subjective measure of subjects' daily energy level was determined by severity of weakness felt by the subjects, measured on visual analog scale (0-100mm, 100mm being most severe weakness).	96 hours
Secondary	Global Evaluation of Safety and Efficacy by Subjects and Investigators	The subjects and investigators will evaluate independently the safety of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor").	96 hours
Secondary	Occurrence of Adverse Events (AEs)		96 hours
Secondary	Associated Symptoms Such as Vomiting		96 hours
Secondary	Stool Consistency	Stool consistency is measured by Bristol Stool Form Scale 1-7.; Separate hard lumps, like nuts (hard to pass); Sausage-shaped, but lumpy; Like a sausage but with cracks on its surface; Like a sausage or snake, smooth and soft; Soft blobs with clear cut edges (easy to pass); Fluffy pieces with ragged edges, a mushy stool; Watery, no solid pieces, entirely liquid Stool consistency is the mean of the scale measured each day.	96 hours
Secondary	Severity of Nausea	Subjects feeling of nausea was measured on visual analog scale of 0 - 100mm (no nausea to severe nausea).	96 hours