Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP)
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
1 other identifier
interventional
90
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2014
Shorter than P25 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 10, 2014
CompletedFirst Posted
Study publicly available on registry
November 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 5, 2016
January 1, 2016
1.2 years
November 10, 2014
December 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Placebo BID
PLACEBO COMPARATORPlacebo once in the morning and once in the evening.
IW-9179 QD AM + Placebo QD PM
EXPERIMENTALIW-9179 once in the morning and placebo once in the evening.
Placebo QD AM + IW-9179 QD PM
EXPERIMENTALPlacebo once in the morning and IW-9179 once in the evening.
IW-9179 BID
EXPERIMENTALIW-9179 once in the morning and once in the evening
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Ironwood Investigational Site
Birmingham, Alabama, 35203, United States
Ironwood Investigational Site
Dothan, Alabama, 36305, United States
Ironwood Investigational Site
Tucson, Arizona, 85710, United States
Ironwood Investigational Site
North Little Rock, Arkansas, 72117, United States
Ironwood Investigational Site
Chula Vista, California, 91910, United States
Ironwood Investigational Site
Los Angeles, California, 90036, United States
Ironwood Investigational Site
Ventura, California, 93003, United States
Ironwood Investigational Site
Miami, Florida, 33122, United States
Ironwood Investigational Site
Tampa, Florida, 33607, United States
Ironwood Investigational Site
Urbana, Illinois, 61801, United States
Ironwood Investigational Site
Bastrop, Louisiana, 71220, United States
Ironwood Investigational Site
Chesterfield, Michigan, 48047, United States
Ironwood Investigational Site
Rochester, Minnesota, 55905, United States
Ironwood Investigational Site
Great Neck, New York, 11023, United States
Ironwood Investigational Site
New York, New York, 10018, United States
Ironwood Investigational Site
Poughkeepsie, New York, 12601, United States
Ironwood Investigational Site
Greensboro, North Carolina, 27410, United States
Ironwood Investigational Site
Winston-Salem, North Carolina, 27103, United States
Ironwood Investigational Site
Chattanooga, Tennessee, 37421, United States
Ironwood Investigational Site
Houston, Texas, 77015, United States
Ironwood Investigational Site
Webster, Texas, 77598, United States
Ironwood Investigational Site
Ogden, Utah, 84405, United States
Related Publications (1)
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.
PMID: 29079987DERIVED
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
November 10, 2014
First Posted
November 13, 2014
Study Start
October 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
December 5, 2016
Record last verified: 2016-01