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

Phase 2

Terminated

• Conditions: Dyspepsia; Functional Gastrointestinal Disorders
• Interventions: Drug: IW-9179; Drug: Placebo

• Registration Number: NCT01712412
• Lead Sponsor: Ironwood Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-11
• Study First Submitted QC: 2012-10-19
• Study First Posted: 2012-10-23
• Status Verified: 2013-07
• Primary Completion: 2014-02
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-18
• Last Update Posted: 2014-03-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IW-9179	IW-9179	Oral IW-9179 taken daily for two weeks
Placebo	Placebo	Oral placebo taken daily for two weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline 12-lead electrocardiogram (ECG) at day 14 of treatment	Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)
Change from baseline clinical laboratory evaluations at the last day of treatment (day 14)	Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)
Rate of treatment-emergent adverse events	Reported at any time after the first dose, including the 14 days of treatment and 7 days of follow up
Change from baseline vital signs at the day 14 visit and at the end of the study (7 days after the last dose)	Baseline values taken prior to first dose (day 1) compared with values taken at the day 14 visit (14 days after first dose) and at the end of the study (21 days after the first dose)

Secondary Outcome Measures

Name	Time	Method
Post-meal Symptom Severity (PMSS) Assessment	Completed at day 1 and day 14 of the Treatment Period	Assessments completed at 15 min prior to dose, just prior to dose, and every 15 minutes after the first dose through 240 minutes (4 hours after first dose)
Daily Patient Symptom Severity (PSS) Assessment	Average of daily assessments for the 2 weeks just prior to the first dose compared to: 1) the average of the 2 week treatment period, 2) the average of the first week of treatment and 3) the average of the second week of treatment	Assessments recorded on a daily basis
Weekly Symptom Relief (SR) Assessments	Average of week 1 and week 2 prior to treatment compared with the week 1 and week 2 during treatment	Assessments recorded on a weekly basis weekly
Nepean Dyspepsia Index	Baseline NDI score (collected just prior to first dose) compared with End of Treatment NDI (collected just prior to last dose)

Trial Locations

Locations (15)

Andromed Leiden; 🇳🇱 Leiden, Netherlands

PreCare Trial and Recruitment; 🇳🇱 Beek, Netherlands

AZ Sint-Lucas Brugge; 🇧🇪 Brugge, Belgium

Z.O.L. - Campus St. Jan; 🇧🇪 Genk, Belgium

FlevoResearch; 🇳🇱 Almere, Netherlands

Andromed Breda; 🇳🇱 Breda, Netherlands

Andromed Rotterdam; 🇳🇱 Rotterdam, Netherlands

Antwerp University Hospital; 🇧🇪 Edegem, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Maastricht University Med Ctr; 🇳🇱 Maastricht, Netherlands

H. Hartziekenhuis Roselare-Menen vzw; 🇧🇪 Roselare, Belgium

Andromed Noord; 🇳🇱 Groningen, Netherlands

Andromed Eindhoven; 🇳🇱 Eindhoven, Netherlands

CHU Ambroise Pare; 🇧🇪 Mons, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium