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Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC) (OIC)

4. maj 2021 opdateret af: Bausch Health Americas, Inc.

A Randomized, 4-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC) in Patients With Non-malignant Chronic Pain Receiving Opioid Therapy

The purpose of this study is to evaluate the safety and efficacy of a range of oral SP-333 doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain taking opioids.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

292

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Huntsville, Alabama, Forenede Stater, 35801
        • Synergy Research Site
      • Mobile, Alabama, Forenede Stater, 36608
        • Synergy Research Site
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85018
        • Synergy Research Site
    • California
      • Artesia, California, Forenede Stater, 90701
        • Synergy Research Site
      • Laguna Hills, California, Forenede Stater, 92653
        • Synergy Research Site
      • Oceanside, California, Forenede Stater, 92056
        • Synergy Research Site
      • Sacramento, California, Forenede Stater, 95831
        • Synergy Research Site
      • San Diego, California, Forenede Stater, 92103
        • Synergy Research Site
      • San Diego, California, Forenede Stater, 92108
        • Synergy Research Site
      • San Francisco, California, Forenede Stater, 94103
        • Synergy Research Site
    • Florida
      • Hialeah, Florida, Forenede Stater, 33012
        • Synergy Research Site
      • Miami, Florida, Forenede Stater, 33173
        • Synergy Research Site
      • Miami Beach, Florida, Forenede Stater, 33140
        • Synergy Research Site
      • Plant City, Florida, Forenede Stater, 33563
        • Synergy Research Site
      • Plantation, Florida, Forenede Stater, 33317
        • Synergy Research Site
      • Port Orange, Florida, Forenede Stater, 32129
        • Synergy Research Site
      • Sarasota, Florida, Forenede Stater, 34239
        • Synergy Research Site
      • West Palm Beach, Florida, Forenede Stater, 33409
        • Synergy Research Site
      • Winter Haven, Florida, Forenede Stater, 33880
        • Synergy Research Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30312
        • Synergy Research Site
    • Illinois
      • Bloomington, Illinois, Forenede Stater, 61701
        • Synergy Research Site
    • Michigan
      • Traverse City, Michigan, Forenede Stater, 49684
        • Synergy Research Site
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63117
        • Synergy Research Site
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89102
        • Synergy Research Site
    • New York
      • Great Neck, New York, Forenede Stater, 11023
        • Synergy Research Site
      • New York, New York, Forenede Stater, 10016
        • Synergy Research Site
    • North Carolina
      • Concord, North Carolina, Forenede Stater, 28025
        • Synergy Research Site
      • Greensboro, North Carolina, Forenede Stater, 27403
        • Synergy Research Site
      • Salisbury, North Carolina, Forenede Stater, 28144
        • Synergy Research Site
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Synergy Research Site
    • Ohio
      • Dayton, Ohio, Forenede Stater, 45424
        • Synergy Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Synergy Research Site
      • Oklahoma City, Oklahoma, Forenede Stater, 73101
        • Synergy Research Site
      • Oklahoma City, Oklahoma, Forenede Stater, 73119
        • Synergy Research Site
    • Oregon
      • Medford, Oregon, Forenede Stater, 97504
        • Synergy Research Site
    • South Carolina
      • Orangeburg, South Carolina, Forenede Stater, 29118
        • Synergy Research Site
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37421
        • Synergy Research Site
    • Texas
      • Arlington, Texas, Forenede Stater, 76012
        • Synergy Research Site
      • Dallas, Texas, Forenede Stater, 75231
        • Synergy Research Site
      • Dallas, Texas, Forenede Stater, 75218
        • Synergy Research Site
      • Houston, Texas, Forenede Stater, 77081
        • Synergy Research Site
      • San Antonio, Texas, Forenede Stater, 78209
        • Synergy Research Site

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 til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Must be receiving chronic, stable opioid therapy to treat non-malignant pain for at least 3 months prior to screening
  • Must have active OIC at screening
  • Active OIC must be confirmed during baseline screening bowel habit and symptom diary
  • Must be on stable diet

Exclusion Criteria:

  • Has history of chronic therapy for chronic constipation prior to start of opioid therapy, or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (i.e., mechanical obstruction or pseudo-obstruction)
  • Use of medications that might affect bowel movement frequency or constipation-related symptoms (e.g., prokinetics, anti-diarrheal agents, laxatives other than study-defined rescue laxative)
  • Has history of or current cancer (other than basal cell or squamous cell carcinoma of the skin) unless the malignancy has been in complete remission without maintenance chemotherapy for at least 5 years
  • Unstable thyroid disease

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: SP-333 1 mg
1 mg SP-333 orally once daily for 4-week Treatment Period
Medicin: SP-333 1 mg
Tablet
Eksperimentel: SP-333 3 mg
3 mg SP-333 orally once daily for 4-week Treatment Period
Medicin: SP-333 3 mg
Tablet
Eksperimentel: SP-333 6 mg
6 mg SP-333 orally once daily for 4-week Treatment Period
Medicin: SP-333 6 mg
Tablet
Placebo komparator: Placebo
Placebo orally once daily for 4-week Treatment Period
Medicin: Placebo
Tablet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period
Tidsramme: 4 Weeks
Compare SP-333 (1, 3 & 6 mg) with placebo in the treatment of OIC as measured by the change from baseline in the number of spontaneous bowel movements during Week 4 of the 4-week treatment period
4 Weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To assess safety and tolerability of SP-333 in the treatment of non-malignant OIC
Tidsramme: 4 weeks
Compare the safety and tolerability of SP-333 (1, 3 & 6 mg) with placebo as measured by rates of adverse events, clinical laboratory abnormalities and significant changes in vital signs and ECGs.
4 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To evaluate stool consistency over the 4-week Treatment Period
Tidsramme: 4 weeks
Compare SP-333 (1, 3 & 6 mg) with placebo in rates of change from baseline in stool consistency over the 4 weeks of treatment.
4 weeks
To evaluate constipation-related symptoms over the 4-week Treatment Period
Tidsramme: 4 weeks
Compare SP-333 (1, 3 & 6 mg) with placebo in rates of change from baseline in constipation-related symptoms over the 4 weeks of treatment.
4 weeks
To evaluate bowel movement frequency responder rates [Complete Spontaneous Bowel Movements (CSBMs) and Spontaneous Bowel Movements (SBMs)] over the 4-week Treatment Period.
Tidsramme: 4 weeks
Compare SP-333 (1, 3 & 6 mg) with placebo in rates of change from baseline for bowel movement frequency responder rates [Complete Spontaneous Bowel Movements (CSBMs) and Spontaneous Bowel Movements (SBMs)] over the 4 weeks of treatment.
4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bausch Health Americas, Inc.

Efterforskere

  • Studieleder: Renata Tenenbaum, Synergy Pharmaceuticals Inc.

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. november 2013

Primær færdiggørelse (Faktiske)

1. september 2014

Studieafslutning (Faktiske)

1. april 2015

Datoer for studieregistrering

Først indsendt

29. oktober 2013

Først indsendt, der opfyldte QC-kriterier

6. november 2013

Først opslået (Skøn)

13. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2021

Sidst verificeret

1. maj 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SP333201-01

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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Betingelser

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Placeringer

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