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

December 1, 2016 updated by: Ironwood Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35203
        • Ironwood Investigational Site
      • Dothan, Alabama, United States, 36305
        • Ironwood Investigational Site
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Ironwood Investigational Site
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Ironwood Investigational Site
    • California
      • Chula Vista, California, United States, 91910
        • Ironwood Investigational Site
      • Los Angeles, California, United States, 90036
        • Ironwood Investigational Site
      • Ventura, California, United States, 93003
        • Ironwood Investigational Site
    • Florida
      • Miami, Florida, United States, 33122
        • Ironwood Investigational Site
      • Tampa, Florida, United States, 33607
        • Ironwood Investigational Site
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Ironwood Investigational Site
    • Louisiana
      • Bastrop, Louisiana, United States, 71220
        • Ironwood Investigational Site
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Ironwood Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Ironwood Investigational Site
    • New York
      • Great Neck, New York, United States, 11023
        • Ironwood Investigational Site
      • New York, New York, United States, 10018
        • Ironwood Investigational Site
      • Poughkeepsie, New York, United States, 12601
        • Ironwood Investigational Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27410
        • Ironwood Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Ironwood Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Ironwood Investigational Site
    • Texas
      • Houston, Texas, United States, 77015
        • Ironwood Investigational Site
      • Webster, Texas, United States, 77598
        • Ironwood Investigational Site
    • Utah
      • Ogden, Utah, United States, 84405
        • Ironwood Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo BID
Placebo once in the morning and once in the evening.
Drug: Matching Placebo
Experimental: IW-9179 QD AM + Placebo QD PM
IW-9179 once in the morning and placebo once in the evening.
Drug: Matching Placebo
Drug: IW-9179
Experimental: Placebo QD AM + IW-9179 QD PM
Placebo once in the morning and IW-9179 once in the evening.
Drug: Matching Placebo
Drug: IW-9179
Experimental: IW-9179 BID
IW-9179 once in the morning and once in the evening
Drug: IW-9179

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exploratory Endpoint - Daily Severity of Patient-reported Diabetic Gastroparesis Symptoms
Time Frame: Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period
Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ironwood Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

November 10, 2014

First Posted (Estimate)

November 13, 2014

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICP-112-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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