Clinical trial NCT02289846: Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Gastroparesis
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Exploratory Endpoint - Daily Severity of Patient-reported Diabetic Gastroparesis Symptoms
timeFrame: Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Ironwood Investigational Site
state: Alabama
city: Dothan
country: United States
facility: Ironwood Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Ironwood Investigational Site
state: Arizona
city: North Little Rock
country: United States
facility: Ironwood Investigational Site
state: Arkansas
city: Chula Vista
country: United States
facility: Ironwood Investigational Site
state: California
city: Los Angeles
country: United States
facility: Ironwood Investigational Site
state: California
city: Ventura
country: United States
facility: Ironwood Investigational Site
state: California
city: Miami
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Tampa
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Urbana
country: United States
facility: Ironwood Investigational Site
state: Illinois
city: Bastrop
country: United States
facility: Ironwood Investigational Site
state: Louisiana
city: Chesterfield
country: United States
facility: Ironwood Investigational Site
state: Michigan
city: Rochester
country: United States
facility: Ironwood Investigational Site
state: Minnesota
city: Great Neck
country: United States
facility: Ironwood Investigational Site
state: New York
city: New York
country: United States
facility: Ironwood Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: Ironwood Investigational Site
state: New York
city: Greensboro
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Chattanooga
country: United States
facility: Ironwood Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Ironwood Investigational Site
state: Texas
city: Webster
country: United States
facility: Ironwood Investigational Site
state: Texas
city: Ogden
country: United States
facility: Ironwood Investigational Site
state: Utah
Study officials:
References:
citation: 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.