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

Dyspepsia Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01712412
• Other study ID #: ICP-112-201
• Status: Terminated
• Phase: Phase 2
• First received: October 11, 2012
• Last updated: March 18, 2014
• Start date: October 2012
• Est. completion date: March 2014

Study information

• Verified date: July 2013
• Source: Ironwood Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsNetherlands: Medicines Evaluation Board (MEB)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Diseases
• Dyspepsia
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

Drug:
• IW-9179

• Placebo

Locations

Country	Name	City	State
Belgium	AZ Sint-Lucas Brugge	Brugge
Belgium	Antwerp University Hospital	Edegem
Belgium	Z.O.L. - Campus St. Jan	Genk
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	UZ Leuven	Leuven
Belgium	CHU Ambroise Pare	Mons
Belgium	H. Hartziekenhuis Roselare-Menen vzw	Roselare
Netherlands	FlevoResearch	Almere
Netherlands	PreCare Trial and Recruitment	Beek
Netherlands	Andromed Breda	Breda
Netherlands	Andromed Eindhoven	Eindhoven
Netherlands	Andromed Noord	Groningen
Netherlands	Andromed Leiden	Leiden
Netherlands	Maastricht University Med Ctr	Maastricht
Netherlands	Andromed Rotterdam	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Ironwood Pharmaceuticals, Inc.

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Nepean Dyspepsia Index		Baseline NDI score (collected just prior to first dose) compared with End of Treatment NDI (collected just prior to last dose)	No