Phase 2a Study of IW-9179 to Treat Functional Dyspepsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-03-31

Brief Summary

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The objectives of this study are to determine the safety and efficacy of IW-9179 administered to patients with functional dyspepsia (FD).

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Detailed Description

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Conditions

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Dyspepsia Functional Gastrointestinal Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IW-9179

Oral IW-9179 taken daily for two weeks

Group Type EXPERIMENTAL

IW-9179

Intervention Type DRUG

Placebo

Oral placebo taken daily for two weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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IW-9179

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient meets ROME III criteria for functional dyspepsia (FD)
* Patient has a normal esophagogastroduodenoscopy (EGD) either during the Screening Period or within 2 years of the Screening Visit
* Patients who EITHER:

1. Have not used a proton pump inhibitor (PPI) within 4 weeks of the Screening Visit, OR
2. Have used a PPI at a stable dose for at least 4 weeks prior to the Screening Visit;
* Patient meets symptom severity criteria in the Pretreatment Period
* Patient is fluent and literate in Dutch, French, or English

Exclusion Criteria

* Patient meets criteria for gastroesophageal reflux disease (GERD, stable regimen of PPIs acceptable), constipation, diarrhea, lower abdominal pain, or gastroparesis
* Patient has a history of inflammatory bowel disease, chronic pancreatitis, small intestinal bacterial overgrowth, celiac disease, lactose intolerance, polycystic kidney disease, interstitial cystitis, or scleroderma
* Any significant neurological disease or a history of cancer (resected basal cell or squamous cell carcinoma of the skin is acceptable; complete remission of other cancers for 5 years or longer is also acceptable)
* History of active alcoholism or drug addiction within 12 months prior to the Screening Visit
* Hospitalized for a psychiatric condition or has made a suicide attempt during the two years before the Screening Visit
* Any organic or structural disease that can cause abdominal pain or discomfort

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No