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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01712412
Recruitment Status : Terminated (Slow enrollment)
First Posted : October 23, 2012
Last Update Posted : March 19, 2014
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Dyspepsia Functional Gastrointestinal Disorders Drug: IW-9179 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
  2. 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) ]
  3. 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) ]
  4. 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) ]

Secondary Outcome Measures :
  1. Post-meal Symptom Severity (PMSS) Assessment [ Time Frame: Completed at day 1 and day 14 of the Treatment Period ]
    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)

  2. 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 ]
    Assessments recorded on a daily basis

  3. 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 ]
    Assessments recorded on a weekly basis weekly

  4. 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) ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT01712412

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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
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.

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Responsible Party: Ironwood Pharmaceuticals, Inc. Identifier: NCT01712412    
Other Study ID Numbers: ICP-112-201
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: March 19, 2014
Last Verified: July 2013
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms