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

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ClinicalTrials.gov Identifier: NCT02289846
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Gastroparesis Drug: IW-9179 Drug: Matching Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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: IW-9179
Drug: Matching Placebo
Experimental: Placebo QD AM + IW-9179 QD PM
Placebo once in the morning and IW-9179 once in the evening.
Drug: IW-9179
Drug: Matching Placebo
Experimental: IW-9179 BID
IW-9179 once in the morning and once in the evening
Drug: IW-9179



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02289846


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02289846     History of Changes
Other Study ID Numbers: ICP-112-202
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms