- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03097861
Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo
10. januar 2020 oppdatert av: 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).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
552
Fase
- Fase 3
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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Alabama
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Birmingham, Alabama, Forente stater, 35216
- Investigative Site
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Foley, Alabama, Forente stater, 36535
- Investigative Site
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Arkansas
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Little Rock, Arkansas, Forente stater, 72212
- Investigative Site
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California
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Anaheim, California, Forente stater, 92805
- Investigative Site
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Chula Vista, California, Forente stater, 91910
- Investigative Sitee
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Garden Grove, California, Forente stater, 92840
- Investigative Site
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Long Beach, California, Forente stater, 90806
- Investigative Site
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Los Angeles, California, Forente stater, 90057
- Investigative Site
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Panorama City, California, Forente stater, 91402
- Investigative Site
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San Diego, California, Forente stater, 92103
- Investigative Site
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San Marcos, California, Forente stater, 92078
- Investigative Site
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Upland, California, Forente stater, 91786
- Investigative Site
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Colorado
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Colorado Springs, Colorado, Forente stater, 80909
- Investigative Site
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Connecticut
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New London, Connecticut, Forente stater, 06320
- Investigative Site
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Florida
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Clearwater, Florida, Forente stater, 33765
- Investigative Site
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Coral Springs, Florida, Forente stater, 33065
- Investigative Site
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DeLand, Florida, Forente stater, 32720
- Investigative Site
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Hialeah, Florida, Forente stater, 33012
- Investigative Site
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Jupiter, Florida, Forente stater, 33458
- Investigative Site
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Miami, Florida, Forente stater, 33143
- Investigative Site
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Miami, Florida, Forente stater, 33165
- Investigative Site
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Miami, Florida, Forente stater, 33142
- Investigative Site
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Miami, Florida, Forente stater, 33143
- Investigative Site 2
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Orlando, Florida, Forente stater, 32806
- Investigative Site
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Plantation, Florida, Forente stater, 33322
- Investigative Site
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Port Orange, Florida, Forente stater, 32129
- Investigative Sitee
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Port Saint Lucie, Florida, Forente stater, 34952
- Investigative Site
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Tampa, Florida, Forente stater, 33609
- Investigative Site
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Tampa, Florida, Forente stater, 33634
- Investigative Site
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West Palm Beach, Florida, Forente stater, 33409
- Investigative Site
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Georgia
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Athens, Georgia, Forente stater, 30607
- Investigative Site
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Snellville, Georgia, Forente stater, 30078
- Investigative Site
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Stockbridge, Georgia, Forente stater, 30281
- Investigative Site
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Idaho
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Blackfoot, Idaho, Forente stater, 83221
- Investigative Site
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Boise, Idaho, Forente stater, 83712
- Investigative Site
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Meridian, Idaho, Forente stater, 83642
- Investigative Site
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Louisiana
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Lake Charles, Louisiana, Forente stater, 70601
- Investigative Site
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New Orleans, Louisiana, Forente stater, 70124
- Investigative Site
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Shreveport, Louisiana, Forente stater, 71101
- Investigative Site
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Maryland
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Chevy Chase, Maryland, Forente stater, 20815
- Investigative Site
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Hagerstown, Maryland, Forente stater, 21742
- Investigative Site
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Massachusetts
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New Bedford, Massachusetts, Forente stater, 02740
- Investigative Site
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Missouri
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Jackson, Missouri, Forente stater, 39202
- Investigative Site
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Nebraska
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Bellevue, Nebraska, Forente stater, 68005
- Investigative Sitee
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Nevada
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Las Vegas, Nevada, Forente stater, 89119
- Investigative Site
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New York
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Bronx, New York, Forente stater, 10459
- Investigative Site
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North Carolina
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High Point, North Carolina, Forente stater, 27262
- Investigative Sitee
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Raleigh, North Carolina, Forente stater, 27612
- Investigative Site
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Ohio
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Cleveland, Ohio, Forente stater, 44122
- Investigative Site
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Mentor, Ohio, Forente stater, 44060
- Investigative Site
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Oklahoma
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Midwest City, Oklahoma, Forente stater, 73110
- Investigative Site
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19152
- Investigative Site
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South Carolina
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Charleston, South Carolina, Forente stater, 29406
- Investigative Site
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Spartanburg, South Carolina, Forente stater, 29303
- Investigative Site
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Tennessee
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Chattanooga, Tennessee, Forente stater, 37421
- Investigative Site
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Jackson, Tennessee, Forente stater, 38305
- Investigative Site 2
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Jackson, Tennessee, Forente stater, 38305
- Investigative Site
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Texas
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Houston, Texas, Forente stater, 77058
- Investigative Site
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Houston, Texas, Forente stater, 77099
- Investigative Site
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Longview, Texas, Forente stater, 75605
- Investigative Site
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McAllen, Texas, Forente stater, 78504
- Investigative Site
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Sugar Land, Texas, Forente stater, 77479
- Investigative Site
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Utah
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Layton, Utah, Forente stater, 84041
- Investigative Site
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Taylorsville, Utah, Forente stater, 84123
- Investigative Site
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West Jordan, Utah, Forente stater, 84088
- Investigative Site
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Virginia
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Newport News, Virginia, Forente stater, 23606
- Investigative Site
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Richmond, Virginia, Forente stater, 23220
- Investigative Site
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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:
- 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
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 |
---|---|
Aktiv komparator: Lubiprostone Capsule
Lubiprostone 24 mcg capsule twice daily (BID) for 7 days.
|
24 mcg administered orally BID
Andre navn:
|
Eksperimentell: Lubiprostone Sprinkle
Lubiprostone 24 mcg sprinkle BID for 7 days.
|
24 mcg administered orally BID
Andre navn:
|
Placebo komparator: Placebo
Placebo matching to lubiprostone (sprinkle/capsule) BID for 7 days.
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24 mcg administered orally BID
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
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 |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Mean SBM Consistency Score Within 1 Week
Tidsramme: during the 1-week treatment period
|
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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 (Faktiske)
13. mars 2017
Primær fullføring (Faktiske)
17. august 2017
Studiet fullført (Faktiske)
17. august 2017
Datoer for studieregistrering
Først innsendt
27. mars 2017
Først innsendt som oppfylte QC-kriteriene
30. mars 2017
Først lagt ut (Faktiske)
31. mars 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. januar 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. januar 2020
Sist bekreftet
1. januar 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SCMP-0211-302
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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