- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01712412
Phase 2a Study of IW-9179 to Treat Functional Dyspepsia
18. marts 2014 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
10
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Brugge, Belgien, 8310
- AZ Sint-Lucas Brugge
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Edegem, Belgien, 2650
- Antwerp University Hospital
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Genk, Belgien, 3600
- Z.O.L. - Campus St. Jan
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Gent, Belgien, 9000
- Universitair Ziekenhuis Gent
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Leuven, Belgien, 3000
- UZ Leuven
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Mons, Belgien, 7000
- CHU Ambroise Pare
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Roselare, Belgien, 8800
- H. Hartziekenhuis Roselare-Menen vzw
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Almere, Holland, 1311 RL
- FlevoResearch
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Beek, Holland, 6191 JW
- PreCare Trial and Recruitment
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Breda, Holland, 4811 SW
- Andromed Breda
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Eindhoven, Holland, 5616GB
- Andromed Eindhoven
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Groningen, Holland, 9711 SG
- Andromed Noord
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Leiden, Holland, 2352 RA
- Andromed Leiden
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Maastricht, Holland, 6229 HX
- Maastricht University Med Ctr
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Rotterdam, Holland, 3021 HC
- Andromed Rotterdam
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2012
Primær færdiggørelse (Faktiske)
1. februar 2014
Studieafslutning (Faktiske)
1. marts 2014
Datoer for studieregistrering
Først indsendt
11. oktober 2012
Først indsendt, der opfyldte QC-kriterier
19. oktober 2012
Først opslået (Skøn)
23. oktober 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
19. marts 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. marts 2014
Sidst verificeret
1. juli 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ICP-112-201
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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