Health Condition 1: R197- Diarrhea, unspecified
Conditions
Interventions
Intervention1: Test product: Dioctahedral Smectite Plus
Sachets
: Dosage form and dose strengths: Solid oral
dosage form (Sachets)
Dioctahedral Smectite
3 g
Control Intervention1: Comparator: Placebo sachets
: Dosage form and dose strengths: Solid oral
dosage form (Sachets), Placebo 3 g
Sponsors
Macleods Pharmaceuticals Ltd
Macleods Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: A subject must fulfill all of the inclusion criteria to be enrolled in the study 1. Male and females between 18-65 years (both ages inclusive) 2. Subject has a diagnosis of acute diarrhea presumed of infectious origin, defined as The passage of 3 or more unformed loose or watery stools (rated according to the Bristol scale) per day without associated alarm symptoms marked with asterisk in the exclusion criteria Having started within 48 hours before Visit 1 (first study drug intake time). 3. Subject has, usually, normal bowel habits, (Rome III criteria), that is at least 3 stools per week and no more than 3 stools per day 4. Subjects willing and able to comply to protocol-defined study procedures 5. Subjects willing to voluntarily give their written informed consent to participate in the study Symptoms considered as alarm symptoms are identified in the exclusion criteria (1) Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional Bowel Disorders. Gastroenterology 2006,131:1480 91.
Exclusion criteria
Exclusion criteria: subject must not fulfill any exclusion criteria to be enrolled in the study: Exclusion related to acute diarrhea episode 1. At least one of the following alarm symptoms as per ROME III criteria i). Bloody diarrhea ii). Pus in the stools iii). Fever grater than or equal to 38.0 degree celsius (That is grater than or equal to 100.4 degree fahrenheit) iv). Moderate or severe dehydration according to World Health Organisation (WHO) definition, requiring intravenous (IV) rehydration, v). Repeated vomiting vi). Persistent abdominal pain These symptoms are considered as alarm symptoms 2. Other episode of acute watery diarrhea within the previous 30 days, 3. Persistent diarrhea, defined as acutely starting episode of diarrhea lasting more than 14 days 4. History of chronic diarrhea (Rome III criteria); i.e. 3 or more loose or watery stools per day for at least 12 weeks, consecutive or not, in the preceding 12 months 5. Travellers diarrhea defined as a diarrheal episode due to contamination experienced by subjects having travelled in at risk countries, or coming from abroad and experiencing locally an acute diarrhea episode, occurring usually within the first 2 weeks of the stay in a foreign environment. 6. Diarrhea suspected to be induced by any medication drug (example antibiotic therapy, including Clostridium difficile-induced diarrhea, within 1 week before entry in the study, laxative agent, thyroid hormone (at a nonstabilised dosing), colchicine intake, etc.) 7. Anti-diarrheal medication intake during the last month or currently on medication which is known to cause diarrhea 8. Any subject requiring repeated intake of a drug with a narrow therapeutic margin (for example, digoxin, theophylline, etc.) 9. History of hypersensitivity to dioctahedral smectite or its excipients or placebo components, 10. Subject currently receiving or and in the opinion of the investigator likely to require treatment during the study with drugs that are not permitted by the study protocol (for example, antibiotic agents, anti-diarrheal agents, antiemetic drug, antispasmodic drug, etc.) during the study 11. Subjects use of any investigational medication or participation in the clinical trial within the last 30 days before entering this study 12. History of gastric or intestinal resection, or vagotomy 13. Known digestive malabsorption disease, including coeliac disease 14. Any suspicion of abdominal surgery needed during study period 15. Known inflammatory bowel disease. 16. Known Human immunodeficiency virus (HIV) positive status 17. Known or suspected immunosuppression 18. Known severe renal or hepatic insufficiency 19. History of, or known current, problems with alcohol abuse and or known drug addict), 20. Have participated in any other clinical trial within 1 month prior to screening visit 21. Any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and or evidence of an uncooperative attitude 22. Pregnant or lactating women. 23. Female of childbearing potential not willing to use adequate and consistent method of contraception during entire study period 24. Any clinically significant medical and or surgical condition or a laboratory abnormality that, in the opinion of the inv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to recovery, defined as time from the 1st study treatment intake to the first formed stool followed by a non watery stool. Consistency will be rated according to the Bristol scale. (Test product versus Placebo)Timepoint: Day 5, day 9 from study treatment dispense | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Endpoints Abdominal pain intensity (rated with a 4-point ordinal scale 1 is equal to mild, 2 is equal to moderate, 3 is equal to severe, 4 is equal to very severe) per 12hour period after 1st study treatment intake Time (hours, minutes) from diarrhea onset to recovery defined as first formed stool followed by a non-watery stool from the 1st study treatment intake Time (hours, minutes) from first watery stool to the first formed stool from the 1st study treatment intake Time (hours, minutes) from the 1st study treatment intake to the last watery stool Number of stools, per 12-hour period from the 1st study treatment intake Number of watery stools, per 12-hour period from the 1st study treatment intake Percentage of subjects with associated symptoms such as nausea, vomiting, abdominal pain, and anal irritation, per 12-hour period after 1st study treatment intakeTimepoint: day 5, day 9 from study treatment dispense | — |
Countries
India
Contacts
Public ContactPriyanka Shrivastava
Macleods Pharmaceuticals
Outcome results
None listed