DyspepsiaPhase 2NCT01712412
Phase 2a Study of IW-9179 to Treat Functional Dyspepsia
A Phase 2 study testing IW-9179 in people with Dyspepsia and Functional Gastrointestinal Disorders, run by Ironwood Pharmaceuticals, Inc. at 15 sites in 2 countries.
Trial summary
The objectives of this study are to determine the safety and efficacy of IW-9179 administered to patients with functional dyspepsia (FD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspepsia, Functional Gastrointestinal Disorders
- What is being tested?
- IW-9179
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Oct 2012to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Have not used a proton pump inhibitor (PPI) within 4 weeks of the Screening Visit, OR
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Netherlands8 sites
FlevoResearch
Almere Stad, 1311 RL
PreCare Trial and Recruitment
Beek, 6191 JW
Andromed Breda
Breda, 4811 SW
Andromed Eindhoven
Eindhoven, 5616GB
Andromed Noord
Groningen, 9711 SG
Andromed Leiden
Leiden, 2352 RA
Maastricht University Med Ctr
Maastricht, 6229 HX
Andromed Rotterdam
Rotterdam, 3021 HC
Belgium7 sites
AZ Sint-Lucas Brugge
Bruges, 8310
Antwerp University Hospital
Edegem, 2650
Z.O.L. - Campus St. Jan
Genk, 3600
Universitair Ziekenhuis Gent
Ghent, 9000
UZ Leuven
Leuven, 3000
CHU Ambroise Pare
Mons, 7000
H. Hartziekenhuis Roselare-Menen vzw
Roeselare, 8800
About this study
The objectives of this study are to determine the safety and efficacy of IW-9179 administered to patients with functional dyspepsia (FD).
- Conditions
- Dyspepsia, Functional Gastrointestinal Disorders
- Being tested
- IW-9179, Placebo
- Medical subject headings
- Dyspepsia, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IW-9179Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| IW-9179 | Experimental | Oral IW-9179 taken daily for two weeks Receives: Drug: IW-9179 |
| Placebo | Placebo comparator | Oral placebo taken daily for two weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of treatment-emergent adverse events
Measured: Reported at any time after the first dose, including the 14 days of treatment and 7 days of follow up
Change from baseline 12-lead electrocardiogram (ECG) at day 14 of treatment
Measured: Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)
Change from baseline clinical laboratory evaluations at the last day of treatment (day 14)
Measured: Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)
Change from baseline vital signs at the day 14 visit and at the end of the study (7 days after the last dose)
Measured: 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 (4)
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)
Measured: Completed at day 1 and day 14 of the Treatment Period
Daily Patient Symptom Severity (PSS) Assessment
Assessments recorded on a daily basis
Measured: 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
Weekly Symptom Relief (SR) Assessments
Assessments recorded on a weekly basis weekly
Measured: Average of week 1 and week 2 prior to treatment compared with the week 1 and week 2 during treatment
Nepean Dyspepsia Index
Measured: Baseline NDI score (collected just prior to first dose) compared with End of Treatment NDI (collected just prior to last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2014
- Study completionMar 2014
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712412
- Sponsor's protocol ID
- ICP-112-201
- Status last verified
- Jul 2013
- First submitted
- 11 Oct 2012
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Study of IW-9179 to Treat Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT01712412
- Acronym / sponsor ID
- ICP-112-201
- Conditions
- Dyspepsia, Functional Gastrointestinal Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 23 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to determine the safety and efficacy of IW-9179 administered to patients with functional dyspepsia (FD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IW-9179 | Experimental | Drug: IW-9179Oral IW-9179 taken daily for two weeks |
| Placebo | Placebo comparator | Drug: PlaceboOral placebo taken daily for two weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Patient meets symptom severity criteria in the Pretreatment Period
- Patient is fluent and literate in Dutch, French, or English
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IW-9179 | Drug | IW-9179 |
| Placebo | Drug | Placebo |
Primary outcome
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
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)
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)
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)
4 secondary outcomes
Post-meal Symptom Severity (PMSS) Assessment
Time frame: Completed at day 1 and day 14 of the Treatment Period
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
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
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)
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IW-9179 in people with Dyspepsia and Functional Gastrointestinal Disorders, run by Ironwood Pharmaceuticals, Inc. at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2014.