Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP)
NCT ID: NCT02289846
Last Updated: 2016-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2014-10-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo BID
Placebo once in the morning and once in the evening.
Matching Placebo
IW-9179 QD AM + Placebo QD PM
IW-9179 once in the morning and placebo once in the evening.
IW-9179
Matching Placebo
Placebo QD AM + IW-9179 QD PM
Placebo once in the morning and IW-9179 once in the evening.
IW-9179
Matching Placebo
IW-9179 BID
IW-9179 once in the morning and once in the evening
IW-9179
Interventions
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IW-9179
Matching Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Ironwood Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Ironwood Investigational Site
Birmingham, Alabama, United States
Ironwood Investigational Site
Dothan, Alabama, United States
Ironwood Investigational Site
Tucson, Arizona, United States
Ironwood Investigational Site
North Little Rock, Arkansas, United States
Ironwood Investigational Site
Chula Vista, California, United States
Ironwood Investigational Site
Los Angeles, California, United States
Ironwood Investigational Site
Ventura, California, United States
Ironwood Investigational Site
Miami, Florida, United States
Ironwood Investigational Site
Tampa, Florida, United States
Ironwood Investigational Site
Urbana, Illinois, United States
Ironwood Investigational Site
Bastrop, Louisiana, United States
Ironwood Investigational Site
Chesterfield, Michigan, United States
Ironwood Investigational Site
Rochester, Minnesota, United States
Ironwood Investigational Site
Great Neck, New York, United States
Ironwood Investigational Site
New York, New York, United States
Ironwood Investigational Site
Poughkeepsie, New York, United States
Ironwood Investigational Site
Greensboro, North Carolina, United States
Ironwood Investigational Site
Winston-Salem, North Carolina, United States
Ironwood Investigational Site
Chattanooga, Tennessee, United States
Ironwood Investigational Site
Houston, Texas, United States
Ironwood Investigational Site
Webster, Texas, United States
Ironwood Investigational Site
Ogden, Utah, United States
Countries
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References
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Ervin CM, Reasner DS, Hanlon JT, Fehnel SE. Exploring the Diabetic Gastroparesis Patient Experience: Patient Exit Interviews. Adv Ther. 2017 Dec;34(12):2680-2692. doi: 10.1007/s12325-017-0632-6. Epub 2017 Oct 27.
Other Identifiers
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ICP-112-202
Identifier Type: -
Identifier Source: org_study_id