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Itopride HCI

Phase 2

Irritable Bowel Syndrome | Small molecule | Gastrointestinal |Abbott Laboratories|Last Updated: Jun 18, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment268

FDA Designations

No designations recorded

Clinical trial landscape

Itopride HCI · 1 trial · 1 indication

Phase 2 1
NCT01027260Study to Evaluate the Role of Itopride HCI in Patients With Irritable Bowel Syndrome With Predominant ConstipationIrritable Bowel Syndrome
COMPLETED268 Analytics
PHASE2COMPLETED
Study to Evaluate the Role of Itopride HCI in Patients With Irritable Bowel Syndrome With Predominant Constipation
Irritable Bowel Syndrome
NCT01027260268
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Study Endpoints

Primary Endpoints

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 Endpoints

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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Itopride 50 mgACTIVE_COMPARATOR -
Itopride 100 mgACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Itopride HCI 50 mgDRUGVariable dosing
Itopride HCI 100 mgDRUGVariable dosing
PlaceboDRUGVariable dosing
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Male or female patient fulfilling the Rome III criteria for IBS-C 2. Signed informed consent at screening visit Exclusion Criteria: 1. Patients having significant diarrhea at least 25% of the time during the past 3 months 2. Patients having alarm symptoms or signs 3. Chroni...

Countries:Pakistan
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Competitive Landscape -Irritable Bowel Syndrome 12 trials

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV2PHASE3Eluxadoline
Ardelyx, Inc.ARDX3PHASE3Tenapanor
Disc Medicine, Inc.IRON1PHASE2DISC-0974
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK2 - Undisclosed
Johnson & JohnsonJNJ1 - Anti TNF therapy including infliximab, No Biologics
Cooper Companies, Inc.COO1N/AUndisclosed
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Frequently asked questions about Itopride HCI

What is Itopride HCI used for?

Itopride HCI is an investigational small molecule being studied for the treatment of Irritable Bowel Syndrome (IBS), specifically in patients with IBS with predominant constipation. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes Itopride HCI?

Itopride HCI is being developed by Abbott Laboratories, a company traded on the stock exchange under the ticker symbol ABT. The drug is currently in Phase 2 clinical trials for the treatment of Irritable Bowel Syndrome.

What phase is Itopride HCI in?

Itopride HCI is in Phase 2 clinical development. It is an investigational drug being studied for Irritable Bowel Syndrome and has not yet received regulatory approval. The drug is not approved for any use and remains under clinical investigation.

What clinical trials is Itopride HCI in?

Itopride HCI has one completed clinical trial, identified as NCT01027260, which was a Phase 2 study evaluating the drug in patients with Irritable Bowel Syndrome with predominant constipation. The trial enrolled 268 participants and was conducted in Pakistan.

Is Itopride HCI FDA approved?

Itopride HCI is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Irritable Bowel Syndrome. The drug has not completed the clinical trial process necessary to seek regulatory approval.