Study to Evaluate the Role of Itopride HCI in Patients With Irritable Bowel Syndrome With Predominant Constipation

NCT01027260 | Completed Phase 2

• 1 other identifier: R10-257
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 4

Brief Summary

Patients suffering from Irritable Bowel Syndrome with predominant constipation will be provided with the study medication. The study medication will be evaluated for its efficacy in relieving the symptoms

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Patients will be asked a simple but well validated question "If there is a satisfactory relief of the symptoms"

  2 weeks and 4 weeks after the start of the treatment

Secondary Outcomes (2)

• Subjects will be assessed based on Irritable Bowel Syndrome Severity Score (IBSSS).

  2 weeks and 4 weeks after the start of the treatment

• Safety based on the laboratory tests before and at the end of the treatment.

  4 weeks during the treatment period and 4 weeks following post- therapy period.

Study Arms (3)

Itopride 50 mg

ACTIVE COMPARATOR

Drug: Itopride HCI 50 mg

Itopride 100 mg

ACTIVE COMPARATOR

Drug: Itopride HCI 100 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Itopride HCI 50 mg DRUG

Variable dosing

Also known as: ABT-654, Itopride HCI, Ganaton

Itopride 50 mg

Itopride HCI 100 mg DRUG

Variable dosing

Also known as: ABT-654, Itopride HCI, Ganaton

Itopride 100 mg

Placebo DRUG

Variable dosing

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female patient fulfilling the Rome III criteria for IBS-C
• Signed informed consent at screening visit

You may not qualify if:

• 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 would interfere 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 in laboratory values (AST/ALT greater than twice the upper limit of normal, serum creatinine \* 2 mg/dl \[177 µmol/l\] according to the medical judgement of the investigator
• 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 of contraception.

Sponsors & Collaborators

• Abbott: lead

Study Sites (4)

Site Reference ID/Investigator# 5870

Karachi, 74800, Pakistan

Location

Site Reference ID/Investigator# 21441

Karachi, Pakistan

Location

Site Reference ID/Investigator# 6130

Lahore, Pakistan

Location

Site Reference ID/Investigator# 8535

Rawalpindi, Pakistan

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: December 7, 2009
• Study Start: June 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

PA (4)