Clinical trial NCT01712412: Phase 2a Study of IW-9179 to Treat Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dyspepsia
Functional Gastrointestinal Disorders
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-23
Enrollment: 10
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 determine the safety and efficacy of IW-9179 administered to patients with functional dyspepsia (FD).


Eligibility criteria: Inclusion Criteria:

* Patient meets ROME III criteria for functional dyspepsia (FD)
* Patient has a normal esophagogastroduodenoscopy (EGD) either during the Screening Period or within 2 years of the Screening Visit
* Patients who EITHER:

  1. Have not used a proton pump inhibitor (PPI) within 4 weeks of the Screening Visit, OR
  2. Have used a PPI at a stable dose for at least 4 weeks prior to the Screening Visit;
* Patient meets symptom severity criteria in the Pretreatment Period
* Patient is fluent and literate in Dutch, French, or English

Exclusion Criteria:

* Patient meets criteria for gastroesophageal reflux disease (GERD, stable regimen of PPIs acceptable), constipation, diarrhea, lower abdominal pain, or gastroparesis
* Patient has a history of inflammatory bowel disease, chronic pancreatitis, small intestinal bacterial overgrowth, celiac disease, lactose intolerance, polycystic kidney disease, interstitial cystitis, or scleroderma
* Any significant neurological disease or a history of cancer (resected basal cell or squamous cell carcinoma of the skin is acceptable; complete remission of other cancers for 5 years or longer is also acceptable)
* History of active alcoholism or drug addiction within 12 months prior to the Screening Visit
* Hospitalized for a psychiatric condition or has made a suicide attempt during the two years before the Screening Visit
* Any organic or structural disease that can cause abdominal pain or discomfort

Primary outcomes:
measure: Rate of treatment-emergent adverse events
timeFrame: Reported at any time after the first dose, including the 14 days of treatment and 7 days of follow up
measure: Change from baseline 12-lead electrocardiogram (ECG) at day 14 of treatment
timeFrame: Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)
measure: Change from baseline clinical laboratory evaluations at the last day of treatment (day 14)
timeFrame: Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)
measure: Change from baseline vital signs at the day 14 visit and at the end of the study (7 days after the last dose)
timeFrame: Baseline values taken prior to first dose (day 1) compared with values taken at the day 14 visit (14 days after first dose) and at the end of the study (21 days after the first dose)
Secondary outcomes:
measure: Post-meal Symptom Severity (PMSS) Assessment
timeFrame: Completed at day 1 and day 14 of the Treatment Period
measure: Daily Patient Symptom Severity (PSS) Assessment
timeFrame: Average of daily assessments for the 2 weeks just prior to the first dose compared to: 1) the average of the 2 week treatment period, 2) the average of the first week of treatment and 3) the average of the second week of treatment
measure: Weekly Symptom Relief (SR) Assessments
timeFrame: Average of week 1 and week 2 prior to treatment compared with the week 1 and week 2 during treatment
measure: Nepean Dyspepsia Index
timeFrame: Baseline NDI score (collected just prior to first dose) compared with End of Treatment NDI (collected just prior to last dose)
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ Sint-Lucas Brugge
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Genk
country: Belgium
facility: Z.O.L. - Campus St. Jan
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Mons
country: Belgium
facility: CHU Ambroise Pare
city: Roselare
country: Belgium
facility: H. Hartziekenhuis Roselare-Menen vzw
city: Almere
country: Netherlands
facility: FlevoResearch
city: Beek
country: Netherlands
facility: PreCare Trial and Recruitment
city: Breda
country: Netherlands
facility: Andromed Breda
city: Eindhoven
country: Netherlands
facility: Andromed Eindhoven
city: Groningen
country: Netherlands
facility: Andromed Noord
city: Leiden
country: Netherlands
facility: Andromed Leiden
city: Maastricht
country: Netherlands
facility: Maastricht University Med Ctr
city: Rotterdam
country: Netherlands
facility: Andromed Rotterdam
Study officials:
References: