Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01712412
Other study ID # ICP-112-201
Secondary ID
Status Terminated
Phase Phase 2
First received October 11, 2012
Last updated March 18, 2014
Start date October 2012
Est. completion date March 2014

Study information

Verified date July 2013
Source Ironwood Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health ProductsNetherlands: Medicines Evaluation Board (MEB)
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date March 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
IW-9179

Placebo


Locations

Country Name City State
Belgium AZ Sint-Lucas Brugge Brugge
Belgium Antwerp University Hospital Edegem
Belgium Z.O.L. - Campus St. Jan Genk
Belgium Universitair Ziekenhuis Gent Gent
Belgium UZ Leuven Leuven
Belgium CHU Ambroise Pare Mons
Belgium H. Hartziekenhuis Roselare-Menen vzw Roselare
Netherlands FlevoResearch Almere
Netherlands PreCare Trial and Recruitment Beek
Netherlands Andromed Breda Breda
Netherlands Andromed Eindhoven Eindhoven
Netherlands Andromed Noord Groningen
Netherlands Andromed Leiden Leiden
Netherlands Maastricht University Med Ctr Maastricht
Netherlands Andromed Rotterdam Rotterdam

Sponsors (1)

Lead Sponsor Collaborator
Ironwood Pharmaceuticals, Inc.

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of treatment-emergent adverse events Reported at any time after the first dose, including the 14 days of treatment and 7 days of follow up Yes
Primary Change from baseline 12-lead electrocardiogram (ECG) at day 14 of treatment Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14) Yes
Primary Change from baseline clinical laboratory evaluations at the last day of treatment (day 14) Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14) Yes
Primary Change from baseline vital signs at the day 14 visit and at the end of the study (7 days after the last dose) 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) Yes
Secondary Post-meal Symptom Severity (PMSS) Assessment 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) Completed at day 1 and day 14 of the Treatment Period No
Secondary Daily Patient Symptom Severity (PSS) Assessment Assessments recorded on a daily basis 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 No
Secondary Weekly Symptom Relief (SR) Assessments Assessments recorded on a weekly basis weekly Average of week 1 and week 2 prior to treatment compared with the week 1 and week 2 during treatment No
Secondary Nepean Dyspepsia Index Baseline NDI score (collected just prior to first dose) compared with End of Treatment NDI (collected just prior to last dose) No
See also
  Status Clinical Trial Phase
Recruiting NCT06094062 - Smartphone App-assisted PPI N/A
Completed NCT03941288 - Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia Phase 2
Completed NCT04429802 - The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity N/A
Not yet recruiting NCT06369753 - Visible Abdominal Distension N/A
Withdrawn NCT02863822 - Study to Evaluate Dietary Modification in Patients With Functional Dyspepsia. N/A
Recruiting NCT00978159 - Esomeprazole or Famotidine in the Management of Aspirin Related Non-Ulcer Dyspepsia Phase 4
Completed NCT00723502 - Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients Phase 2
Terminated NCT00220844 - Tricyclic Antidepressants (TCAs) on Gastric Emptying N/A
Completed NCT00217347 - Evaluation of Efficiency of Esophageal Capsule Endoscopy in the Screening of Patients With Gastroesophageal Reflux Disease or Dyspepsia as Compared to Upper Endoscopy N/A
Completed NCT00148603 - Montelukast in the Treatment of Duodenal Eosinophilia N/A
Completed NCT00232037 - Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia Phase 3
Completed NCT00164996 - Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patient With or Without Local Pharyngeal Anaesthesia Phase 3
Completed NCT00232102 - Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia Phase 3
Completed NCT00110968 - Long-term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia Phase 3
Recruiting NCT05718960 - Traditional Dietary Advice Versus Reassurance-alone in Postprandial Functional Dyspepsia N/A
Terminated NCT04247100 - A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders N/A
Completed NCT05750641 - The Efficacy of Removal of Animal Milk From the Diet in Functional Dyspepsia: A Cross-sectional Study
Completed NCT04697641 - Helicobacter Pylori Eradication in Functional Dyspepsia N/A
Completed NCT03252743 - ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study. N/A
Recruiting NCT04918329 - Functional Digestive Disorders Observatory