Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
26. november 2019 opdateret af: Mallinckrodt
A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Pharmacodynamics, Pharmacokinetics, and Tolerability of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation.
Additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
164
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Anniston, Alabama, Forenede Stater, 36207
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California
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Anaheim, California, Forenede Stater, 92801
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Florida
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DeLand, Florida, Forenede Stater, 32720
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Hollywood, Florida, Forenede Stater, 33024
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Orlando, Florida, Forenede Stater, 32809
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South Miami, Florida, Forenede Stater, 33143
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Kansas
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Overland Park, Kansas, Forenede Stater, 66212
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New Jersey
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Marlton, New Jersey, Forenede Stater, 08053
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North Carolina
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Raleigh, North Carolina, Forenede Stater, 27612
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Utah
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Salt Lake City, Utah, Forenede Stater, 84106
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Wisconsin
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West Bend, Wisconsin, Forenede Stater, 53095
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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:
- Medically-confirmed diagnosis of chronic idiopathic constipation
- Willing to discontinue use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility during the study
- Stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors
Exclusion Criteria:
- Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation.
- Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.
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: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: Placebo
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Matching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID)
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Eksperimentel: Lubiprostone
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Liquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Spontaneous Bowel Movements (SBMs) Within 1 Week
Tidsramme: within 1 week
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SBM is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.
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within 1 week
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Consistency of SBMs at Week 1
Tidsramme: at Week 1
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Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid.
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at Week 1
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Overall Stool Consistency at Week 1
Tidsramme: at Week 1
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Overall stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid.
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at Week 1
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Mean Change From Baseline in Stool Consistency at Week 1
Tidsramme: Baseline and Week 1
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Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid.
The change from baseline was calculated as post-treatment value (mean) minus the baseline value (mean).
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Baseline and Week 1
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Overall Straining at Week 1
Tidsramme: Week 1
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Bowel straining was rated on a scale of 0 to 4 (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe).
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Week 1
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Mean Change From Baseline in Straining at Week 1
Tidsramme: Week 1
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Bowel straining was rated as 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.
The change from baseline was calculated as post-treatment value minus the baseline value.
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Week 1
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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 2013
Primær færdiggørelse (Faktiske)
1. januar 2014
Studieafslutning (Faktiske)
1. januar 2014
Datoer for studieregistrering
Først indsendt
19. november 2013
Først indsendt, der opfyldte QC-kriterier
22. november 2013
Først opslået (Skøn)
25. november 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. december 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. november 2019
Sidst verificeret
1. juli 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SCMP-0211-301
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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