Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo
10. januar 2020 opdateret af: Sucampo Pharma Americas, LLC
A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo, in Adult Subjects With Chronic Idiopathic Constipation
The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with Chronic Idiopathic Constipation (CIC).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
552
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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Birmingham, Alabama, Forenede Stater, 35216
- Investigative Site
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Foley, Alabama, Forenede Stater, 36535
- Investigative Site
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72212
- Investigative Site
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California
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Anaheim, California, Forenede Stater, 92805
- Investigative Site
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Chula Vista, California, Forenede Stater, 91910
- Investigative Sitee
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Garden Grove, California, Forenede Stater, 92840
- Investigative Site
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Long Beach, California, Forenede Stater, 90806
- Investigative Site
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Los Angeles, California, Forenede Stater, 90057
- Investigative Site
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Panorama City, California, Forenede Stater, 91402
- Investigative Site
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San Diego, California, Forenede Stater, 92103
- Investigative Site
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San Marcos, California, Forenede Stater, 92078
- Investigative Site
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Upland, California, Forenede Stater, 91786
- Investigative Site
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80909
- Investigative Site
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Connecticut
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New London, Connecticut, Forenede Stater, 06320
- Investigative Site
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Florida
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Clearwater, Florida, Forenede Stater, 33765
- Investigative Site
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Coral Springs, Florida, Forenede Stater, 33065
- Investigative Site
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DeLand, Florida, Forenede Stater, 32720
- Investigative Site
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Hialeah, Florida, Forenede Stater, 33012
- Investigative Site
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Jupiter, Florida, Forenede Stater, 33458
- Investigative Site
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Miami, Florida, Forenede Stater, 33143
- Investigative Site
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Miami, Florida, Forenede Stater, 33165
- Investigative Site
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Miami, Florida, Forenede Stater, 33142
- Investigative Site
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Miami, Florida, Forenede Stater, 33143
- Investigative Site 2
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Orlando, Florida, Forenede Stater, 32806
- Investigative Site
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Plantation, Florida, Forenede Stater, 33322
- Investigative Site
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Port Orange, Florida, Forenede Stater, 32129
- Investigative Sitee
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Port Saint Lucie, Florida, Forenede Stater, 34952
- Investigative Site
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Tampa, Florida, Forenede Stater, 33609
- Investigative Site
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Tampa, Florida, Forenede Stater, 33634
- Investigative Site
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West Palm Beach, Florida, Forenede Stater, 33409
- Investigative Site
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Georgia
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Athens, Georgia, Forenede Stater, 30607
- Investigative Site
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Snellville, Georgia, Forenede Stater, 30078
- Investigative Site
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Stockbridge, Georgia, Forenede Stater, 30281
- Investigative Site
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Idaho
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Blackfoot, Idaho, Forenede Stater, 83221
- Investigative Site
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Boise, Idaho, Forenede Stater, 83712
- Investigative Site
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Meridian, Idaho, Forenede Stater, 83642
- Investigative Site
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Louisiana
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Lake Charles, Louisiana, Forenede Stater, 70601
- Investigative Site
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New Orleans, Louisiana, Forenede Stater, 70124
- Investigative Site
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Shreveport, Louisiana, Forenede Stater, 71101
- Investigative Site
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Maryland
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Chevy Chase, Maryland, Forenede Stater, 20815
- Investigative Site
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Hagerstown, Maryland, Forenede Stater, 21742
- Investigative Site
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Massachusetts
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New Bedford, Massachusetts, Forenede Stater, 02740
- Investigative Site
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Missouri
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Jackson, Missouri, Forenede Stater, 39202
- Investigative Site
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Nebraska
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Bellevue, Nebraska, Forenede Stater, 68005
- Investigative Sitee
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89119
- Investigative Site
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New York
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Bronx, New York, Forenede Stater, 10459
- Investigative Site
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North Carolina
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High Point, North Carolina, Forenede Stater, 27262
- Investigative Sitee
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Raleigh, North Carolina, Forenede Stater, 27612
- Investigative Site
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Ohio
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Cleveland, Ohio, Forenede Stater, 44122
- Investigative Site
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Mentor, Ohio, Forenede Stater, 44060
- Investigative Site
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Oklahoma
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Midwest City, Oklahoma, Forenede Stater, 73110
- Investigative Site
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19152
- Investigative Site
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29406
- Investigative Site
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Spartanburg, South Carolina, Forenede Stater, 29303
- Investigative Site
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37421
- Investigative Site
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Jackson, Tennessee, Forenede Stater, 38305
- Investigative Site 2
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Jackson, Tennessee, Forenede Stater, 38305
- Investigative Site
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Texas
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Houston, Texas, Forenede Stater, 77058
- Investigative Site
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Houston, Texas, Forenede Stater, 77099
- Investigative Site
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Longview, Texas, Forenede Stater, 75605
- Investigative Site
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McAllen, Texas, Forenede Stater, 78504
- Investigative Site
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Sugar Land, Texas, Forenede Stater, 77479
- Investigative Site
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Utah
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Layton, Utah, Forenede Stater, 84041
- Investigative Site
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Taylorsville, Utah, Forenede Stater, 84123
- Investigative Site
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West Jordan, Utah, Forenede Stater, 84088
- Investigative Site
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Virginia
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Newport News, Virginia, Forenede Stater, 23606
- Investigative Site
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Richmond, Virginia, Forenede Stater, 23220
- Investigative Site
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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:
- Either has medically-confirmed diagnosis of chronic constipation (per Rome III), or meets the diagnosis as confirmed using the Rome III constipation module questionnaire during the Screening period.
- Is male or female, 18 or older years of age
- Should be on stable dose of fiber supplement or a concomitant medication for the indication of lowering blood pressure
Exclusion Criteria:
- Has any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation
- Is unable to eat or drink, take oral medications, or to hold down oral medications due to vomiting
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 |
|---|---|
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Aktiv komparator: Lubiprostone Capsule
Lubiprostone 24 mcg capsule twice daily (BID) for 7 days.
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24 mcg administered orally BID
Andre navne:
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Eksperimentel: Lubiprostone Sprinkle
Lubiprostone 24 mcg sprinkle BID for 7 days.
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24 mcg administered orally BID
Andre navne:
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Placebo komparator: Placebo
Placebo matching to lubiprostone (sprinkle/capsule) BID for 7 days.
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24 mcg administered orally BID
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week
Tidsramme: during the 1-week treatment period
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Observed SBM count was based on the observed data reported in the electronic daily diary for the actual number of SBMs during the 1-week treatment period.
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during the 1-week treatment period
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Mean SBM Consistency Score Within 1 Week
Tidsramme: during the 1-week treatment period
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Stool consistency associated with SBMs was rated according to the 7-point Bristol Stool Form Scale (1-7) where 1 = Separate hard lumps, like nuts (hard to pass), 2 = Sausage-shaped but lumpy, 3 = Like a sausage but with cracks on the surface, 4 = Like a sausage or snake, smooth and soft, 5 = Soft blobs with clear-cut edges (passed easily), 6 = Fluffy pieces with ragged edges, a mushy stool, 7 = Watery, no solid pieces; entirely liquid.
Scores in the mid-range of this scale indicate better stool consistency.
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during the 1-week treatment period
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Mean SBM Straining Score Within 1 Week
Tidsramme: during the 1-week treatment period
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Bowel straining associated with SBMs was rated on a scale of 0-4 where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very severe.
Higher score indicates more straining, so a worse condition.
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during the 1-week treatment period
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: From first dose of study medication to follow-up (up to 15 days)
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An adverse event (AE) is any untoward medical occurrence (including clinically significant changes in laboratory values or other clinical tests) experienced by a participant administered a pharmaceutical product regardless of causal relationship with the treatment.
A TEAE is an episode which occur after the administration of the first dose of study medication and within 7 days after final dose.
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From first dose of study medication to follow-up (up to 15 days)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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 (Faktiske)
13. marts 2017
Primær færdiggørelse (Faktiske)
17. august 2017
Studieafslutning (Faktiske)
17. august 2017
Datoer for studieregistrering
Først indsendt
27. marts 2017
Først indsendt, der opfyldte QC-kriterier
30. marts 2017
Først opslået (Faktiske)
31. marts 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. januar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. januar 2020
Sidst verificeret
1. januar 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SCMP-0211-302
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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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