Phase 2a Study of IW-9179 to Treat Functional Dyspepsia

This study has been terminated.
(Slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01712412
First received: October 11, 2012
Last updated: March 18, 2014
Last verified: July 2013
  Purpose

The objectives of this study are to determine the safety and efficacy of IW-9179 administered to patients with functional dyspepsia (FD).


Condition Intervention Phase
Dyspepsia
Functional Gastrointestinal Disorders
Drug: IW-9179
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Ironwood Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Rate of treatment-emergent adverse events [ Time Frame: Reported at any time after the first dose, including the 14 days of treatment and 7 days of follow up ] [ Designated as safety issue: Yes ]
  • Change from baseline 12-lead electrocardiogram (ECG) at day 14 of treatment [ Time Frame: Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14) ] [ Designated as safety issue: Yes ]
  • Change from baseline clinical laboratory evaluations at the last day of treatment (day 14) [ Time Frame: Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14) ] [ Designated as safety issue: Yes ]
  • Change from baseline vital signs at the day 14 visit and at the end of the study (7 days after the last dose) [ Time Frame: 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Post-meal Symptom Severity (PMSS) Assessment [ Time Frame: Completed at day 1 and day 14 of the Treatment Period ] [ Designated as safety issue: No ]
    Assessments completed at 15 min prior to dose, just prior to dose, and every 15 minutes after the first dose through 240 minutes (4 hours after first dose)

  • Daily Patient Symptom Severity (PSS) Assessment [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Assessments recorded on a daily basis

  • Weekly Symptom Relief (SR) Assessments [ Time Frame: Average of week 1 and week 2 prior to treatment compared with the week 1 and week 2 during treatment ] [ Designated as safety issue: No ]
    Assessments recorded on a weekly basis weekly

  • Nepean Dyspepsia Index [ Time Frame: Baseline NDI score (collected just prior to first dose) compared with End of Treatment NDI (collected just prior to last dose) ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: October 2012
Study Completion Date: March 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IW-9179
Oral IW-9179 taken daily for two weeks
Drug: IW-9179
Placebo Comparator: Placebo
Oral placebo taken daily for two weeks
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712412

Locations
Belgium
AZ Sint-Lucas Brugge
Brugge, Belgium, 8310
Antwerp University Hospital
Edegem, Belgium, 2650
Z.O.L. - Campus St. Jan
Genk, Belgium, 3600
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
UZ Leuven
Leuven, Belgium, 3000
CHU Ambroise Pare
Mons, Belgium, 7000
H. Hartziekenhuis Roselare-Menen vzw
Roselare, Belgium, 8800
Netherlands
FlevoResearch
Almere, Netherlands, 1311 RL
PreCare Trial and Recruitment
Beek, Netherlands, 6191 JW
Andromed Breda
Breda, Netherlands, 4811 SW
Andromed Eindhoven
Eindhoven, Netherlands, 5616GB
Andromed Noord
Groningen, Netherlands, 9711 SG
Andromed Leiden
Leiden, Netherlands, 2352 RA
Maastricht University Med Ctr
Maastricht, Netherlands, 6229 HX
Andromed Rotterdam
Rotterdam, Netherlands, 3021 HC
Sponsors and Collaborators
Ironwood Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01712412     History of Changes
Other Study ID Numbers: ICP-112-201
Study First Received: October 11, 2012
Last Updated: March 18, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Netherlands: Medicines Evaluation Board (MEB)

Additional relevant MeSH terms:
Dyspepsia
Digestive System Diseases
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014