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

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

Study Overview

• Status: Terminated
• Conditions: Dyspepsia; Functional Gastrointestinal Disorders
• Intervention / Treatment: Drug: Placebo; Drug: IW-9179

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium, 8310
    • AZ Sint-Lucas Brugge
  • Edegem, Belgium, 2650
    • Antwerp University Hospital
  • Genk, Belgium, 3600
    • Z.O.L. - Campus St. Jan
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Mons, Belgium, 7000
    • CHU Ambroise Pare
  • Roselare, Belgium, 8800
    • H. Hartziekenhuis Roselare-Menen vzw
• Netherlands
  • Almere, Netherlands, 1311 RL
    • FlevoResearch
  • Beek, Netherlands, 6191 JW
    • PreCare Trial and Recruitment
  • Breda, Netherlands, 4811 SW
    • Andromed Breda
  • Eindhoven, Netherlands, 5616GB
    • Andromed Eindhoven
  • Groningen, Netherlands, 9711 SG
    • Andromed Noord
  • Leiden, Netherlands, 2352 RA
    • Andromed Leiden
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Med Ctr
  • Rotterdam, Netherlands, 3021 HC
    • Andromed Rotterdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IW-9179; Oral IW-9179 taken daily for two weeks	Drug: IW-9179
Placebo Comparator: Placebo; Oral placebo taken daily for two weeks	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 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)
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

Outcome Measure	Measure Description	Time Frame
Post-meal Symptom Severity (PMSS) Assessment	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)	Completed at day 1 and day 14 of the Treatment Period
Daily Patient Symptom Severity (PSS) Assessment	Assessments recorded on a daily basis	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
Weekly Symptom Relief (SR) Assessments	Assessments recorded on a weekly basis weekly	Average of week 1 and week 2 prior to treatment compared with the week 1 and week 2 during treatment
Nepean Dyspepsia Index		Baseline NDI score (collected just prior to first dose) compared with End of Treatment NDI (collected just prior to last dose)

Collaborators and Investigators

• Sponsor: Ironwood Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: October 11, 2012
• First Submitted That Met QC Criteria: October 19, 2012
• First Posted (Estimate): October 23, 2012

Study Record Updates

• Last Update Posted (Estimate): March 19, 2014
• Last Update Submitted That Met QC Criteria: March 18, 2014
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: ICP-112-201