Phase 2a Study of IW-9179 to Treat Functional Dyspepsia
18. mars 2014 oppdatert av: Ironwood Pharmaceuticals, Inc.
The objectives of this study are to determine the safety and efficacy of IW-9179 administered to patients with functional dyspepsia (FD).
Studieoversikt
Status
Avsluttet
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
10
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Brugge, Belgia, 8310
- AZ Sint-Lucas Brugge
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Edegem, Belgia, 2650
- Antwerp University Hospital
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Genk, Belgia, 3600
- Z.O.L. - Campus St. Jan
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Gent, Belgia, 9000
- Universitair Ziekenhuis Gent
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Leuven, Belgia, 3000
- UZ Leuven
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Mons, Belgia, 7000
- CHU Ambroise Paré
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Roselare, Belgia, 8800
- H. Hartziekenhuis Roselare-Menen vzw
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Almere, Nederland, 1311 RL
- FlevoResearch
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Beek, Nederland, 6191 JW
- PreCare Trial and Recruitment
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Breda, Nederland, 4811 SW
- Andromed Breda
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Eindhoven, Nederland, 5616GB
- Andromed Eindhoven
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Groningen, Nederland, 9711 SG
- Andromed Noord
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Leiden, Nederland, 2352 RA
- Andromed Leiden
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Maastricht, Nederland, 6229 HX
- Maastricht University Med Ctr
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Rotterdam, Nederland, 3021 HC
- Andromed Rotterdam
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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:
- 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
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: IW-9179
Oral IW-9179 taken daily for two weeks
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Placebo komparator: Placebo
Oral placebo taken daily for two weeks
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Rate of treatment-emergent adverse events
Tidsramme: Reported at any time after the first dose, including the 14 days of treatment and 7 days of follow up
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Reported at any time after the first dose, including the 14 days of treatment and 7 days of follow up
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Change from baseline 12-lead electrocardiogram (ECG) at day 14 of treatment
Tidsramme: Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)
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Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)
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Change from baseline clinical laboratory evaluations at the last day of treatment (day 14)
Tidsramme: Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)
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Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)
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Change from baseline vital signs at the day 14 visit and at the end of the study (7 days after the last dose)
Tidsramme: 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)
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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)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Post-meal Symptom Severity (PMSS) Assessment
Tidsramme: Completed at day 1 and day 14 of the Treatment Period
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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)
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Completed at day 1 and day 14 of the Treatment Period
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Daily Patient Symptom Severity (PSS) Assessment
Tidsramme: 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
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Assessments recorded on a daily basis
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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
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Weekly Symptom Relief (SR) Assessments
Tidsramme: Average of week 1 and week 2 prior to treatment compared with the week 1 and week 2 during treatment
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Assessments recorded on a weekly basis weekly
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Average of week 1 and week 2 prior to treatment compared with the week 1 and week 2 during treatment
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Nepean Dyspepsia Index
Tidsramme: Baseline NDI score (collected just prior to first dose) compared with End of Treatment NDI (collected just prior to last dose)
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Baseline NDI score (collected just prior to first dose) compared with End of Treatment NDI (collected just prior to last dose)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2012
Primær fullføring (Faktiske)
1. februar 2014
Studiet fullført (Faktiske)
1. mars 2014
Datoer for studieregistrering
Først innsendt
11. oktober 2012
Først innsendt som oppfylte QC-kriteriene
19. oktober 2012
Først lagt ut (Anslag)
23. oktober 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
19. mars 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. mars 2014
Sist bekreftet
1. juli 2013
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ICP-112-201
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