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

NCT01712412 | Terminated Phase 2

• 1 other identifier: ICP-112-201
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 15

Brief Summary

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

Conditions

Dyspepsia; Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Post-meal Symptom Severity (PMSS) Assessment

  Completed at day 1 and day 14 of the Treatment Period

• 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

• 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

• Nepean Dyspepsia Index

  Baseline NDI score (collected just prior to first dose) compared with End of Treatment NDI (collected just prior to last dose)

Study Arms (2)

IW-9179

EXPERIMENTAL

Oral IW-9179 taken daily for two weeks

Drug: IW-9179

Placebo

PLACEBO COMPARATOR

Oral placebo taken daily for two weeks

Drug: Placebo

Interventions

IW-9179 DRUG

IW-9179

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Have not used a proton pump inhibitor (PPI) within 4 weeks of the Screening Visit, OR
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ironwood Pharmaceuticals, Inc.: lead

Study Sites (15)

AZ Sint-Lucas Brugge

Bruges, 8310, Belgium

Location

Antwerp University Hospital

Edegem, 2650, Belgium

Location

Z.O.L. - Campus St. Jan

Genk, 3600, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHU Ambroise Pare

Mons, 7000, Belgium

Location

H. Hartziekenhuis Roselare-Menen vzw

Roeselare, 8800, Belgium

Location

FlevoResearch

Almere Stad, 1311 RL, Netherlands

Location

PreCare Trial and Recruitment

Beek, 6191 JW, Netherlands

Location

Andromed Breda

Breda, 4811 SW, Netherlands

Location

Andromed Eindhoven

Eindhoven, 5616GB, Netherlands

Location

Andromed Noord

Groningen, 9711 SG, Netherlands

Location

Andromed Leiden

Leiden, 2352 RA, Netherlands

Location

Maastricht University Med Ctr

Maastricht, 6229 HX, Netherlands

Location

Andromed Rotterdam

Rotterdam, 3021 HC, Netherlands

Location

MeSH Terms

Conditions

Dyspepsia; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 23, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 19, 2014

Record last verified: 2013-07

Locations

BE (7); NL (8)