Phase
Condition
Gastrointestinal Diseases And Disorders
Lactose Intolerance
Colic
Treatment
N/AClinical Study ID
Ages 18-50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female patient fulfilling the Rome III criteria for IBS-C
Signed informed consent at screening visit
Exclusion
Exclusion Criteria:
Patients having significant diarrhea at least 25% of the time during the past 3 months
Patients having alarm symptoms or signs
Chronic diarrhea
History of gastrointestinal haemorrhage, mechanical obstruction or perforation
Patient with clinically relevant ECG abnormalities (prolonged QT interval)
Active psychiatric disorder that would interfere with the study objectives
Health conditions (e.g. age related impairment of cognitive functions) that wouldinterfere with the study objectives or might impair the compliance of the patient
Severe hepatic, renal, cardiac, metabolic, haematological or malignant diseases (including prolactin dependent tumours) or clinically relevant deviations inlaboratory values (AST/ALT greater than twice the upper limit of normal, serumcreatinine * 2 mg/dl [177 µmol/l] according to the medical judgement of theinvestigator
Patient with hypokalemia (serum potassium < 3.5 mmol/l).
History of any known hypersensitivity to the ingredients of the investigational drug
Pregnancy or lactation
Women with childbearing potential who do not apply a medically accepted method ofcontraception.
Study Design
Connect with a study center
Site Reference ID/Investigator# 21441
Karachi,
PakistanSite Not Available
Site Reference ID/Investigator# 5870
Karachi, 74800
PakistanSite Not Available
Site Reference ID/Investigator# 6130
Lahore,
PakistanSite Not Available
Site Reference ID/Investigator# 8535
Rawalpindi,
PakistanSite Not Available

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