Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP)

Diabetic Gastroparesis Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 2a Study of Oral IW-9179 Administered Once and Twice Daily for 4 Weeks to Patients With Diabetic Gastroparesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02289846
• Other study ID #: ICP-112-202
• Status: Completed
• Phase: Phase 2
• First received: November 10, 2014
• Last updated: December 1, 2016
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Ironwood Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The objectives of this study are to evaluate the safety of IW-9179 in patients with diabetic gastroparesis (DGP) and the effect of treatment on the cardinal symptoms of DGP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is a male or non-pregnant, non-breastfeeding female, and is age 18 years or older at the time of the Screening Visit.

• Patient has a confirmed diagnosis of type 1 or type 2 diabetes mellitus.

• Patient has a diagnosis of DGP with no history or evidence of mechanical obstruction, symptoms for at least 3 consecutive months preceding the Screening Visit, and delayed gastric emptying of solids documented within 2 years of the Screening Visit.

• Patient has a normal EGD either during the Screening Period or within 2 years of the Screening Visit, with no evidence of structural or organic disease that may explain the patient's gastroduodenal symptoms.

• Patient is compliant with eDiary completion.

• Patient agrees to refrain from making any new, major lifestyle changes.

• Patient is fluent and literate in English.

Exclusion Criteria:

• Patient has a history or current symptoms of any organic or structural disease that, in the opinion of the investigator, can cause abdominal pain or discomfort and may confound the assessment of DGP symptoms.

• Patients with rumination syndrome, cyclic vomiting syndrome, anorexia nervosa, or bulimia.

• Patient is currently using a gastric electric stimulator or has had endoscopic pyloric injections of botulinum toxin within the 6 months prior to the Screening Visit.

• Patient has been hospitalized within the 2 months prior to the Screening Visit for uncontrolled diabetes mellitus, DGP, or associated malnutrition.

• Patient reports significant diarrhea during the four weeks prior to the Screening Visit, or more than 2 days during either week of the Pretreatment Period.

• Patient has had surgery of the GI tract any time before the Screening Visit, an appendectomy or cholecystectomy during the 3 months before the Screening Visit, non-GI surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months, or other major non-GI surgery during the 30 days before the Screening Visit.

• Patient has a history of cancer (resected basal cell or squamous cell carcinoma of the skin is acceptable).

Study Design

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

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis

Intervention

Drug:
• IW-9179

• Matching Placebo

Locations

Country	Name	City	State
United States	Ironwood Investigational Site	Bastrop	Louisiana
United States	Ironwood Investigational Site	Birmingham	Alabama
United States	Ironwood Investigational Site	Chattanooga	Tennessee
United States	Ironwood Investigational Site	Chesterfield	Michigan
United States	Ironwood Investigational Site	Chula Vista	California
United States	Ironwood Investigational Site	Dothan	Alabama
United States	Ironwood Investigational Site	Great Neck	New York
United States	Ironwood Investigational Site	Greensboro	North Carolina
United States	Ironwood Investigational Site	Houston	Texas
United States	Ironwood Investigational Site	Los Angeles	California
United States	Ironwood Investigational Site	Miami	Florida
United States	Ironwood Investigational Site	New York	New York
United States	Ironwood Investigational Site	North Little Rock	Arkansas
United States	Ironwood Investigational Site	Ogden	Utah
United States	Ironwood Investigational Site	Poughkeepsie	New York
United States	Ironwood Investigational Site	Rochester	Minnesota
United States	Ironwood Investigational Site	Tampa	Florida
United States	Ironwood Investigational Site	Tucson	Arizona
United States	Ironwood Investigational Site	Urbana	Illinois
United States	Ironwood Investigational Site	Ventura	California
United States	Ironwood Investigational Site	Webster	Texas
United States	Ironwood Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ironwood Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exploratory Endpoint - Daily Severity of Patient-reported Diabetic Gastroparesis Symptoms		Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period	No