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Itopride HCI

Phase 2

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

Itopride HCI target and mechanism

Molecular targetDRD2, ACHE
Target classAntagonist
ModalitySmall molecule

Also known as ABT-654, Ganaton

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

Itopride HCI clinical trials

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 SyndromeUnlock trial analytics

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 15 trials

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Frequently asked questions about Itopride HCI

What is Itopride HCI used for?

Itopride HCI is being studied for irritable bowel syndrome, specifically the subtype with predominant constipation. It is a small molecule therapeutic in the gastrointestinal area and is in Phase 2 clinical development. It is not yet approved for this use.

What does Itopride HCI target?

Itopride HCI targets dopamine receptor D2 (DRD2) and acetylcholinesterase (ACHE). It acts as an antagonist at DRD2 and inhibits ACHE, which together support its prokinetic activity in the gastrointestinal tract.

Who is developing Itopride HCI?

Itopride HCI is being developed by Abbott Laboratories, which trades under the ticker ABT. Abbott is the sponsor associated with the clinical development of this asset for irritable bowel syndrome.

What phase is Itopride HCI in?

Itopride HCI is in Phase 2 clinical development. It is investigational and has not been approved for irritable bowel syndrome. The Phase 2 trial has been completed, and no active trials are currently listed.

What clinical trials is Itopride HCI in?

Itopride HCI has been evaluated in one completed Phase 2 trial, NCT01027260, titled Study to Evaluate the Role of Itopride HCI in Patients With Irritable Bowel Syndrome With Predominant Constipation. The randomized, double-blind, placebo-controlled trial enrolled 268 participants in Pakistan.