- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00936559
Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair
12. april 2012 opdateret af: Pfizer
Randomized, Single-Blind, Standard Of Care Control, Dose-Escalating, Multicenter, Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Full Thickness Rotator Cuff Tears Treated By Means Of An Open Surgical Procedure
Study to assess the safety of 3 differing concentrations of BMP-655/ACS in subjects with full thickness Rotator Cuff Tears (RCTs).
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
This decision to terminate enrollment in this study is based on the company's change in prioritization for the portfolio and was not due to any safety concerns, or regulatory interactions.
Patients already enrolled in the study, should continue to complete assessments as described in the protocol.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
13
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
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
25 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male subjects and surgically sterile or postmenopausal female subjects between the ages of 25 and 75 years old with specific full-thickness RCTs identified on closed MRI within 3 months before surgery.
Exclusion Criteria:
- Subjects who have had previous surgical intervention to the shoulder joint under study or additional injury requiring surgical repair or a history of shoulder dislocation in the affected shoulder or physical examination findings of instability in either shoulder
- Subjects who are unable to complete functional evaluations because of any other concurrent injuries or impairment in either the arm
- Subjects identified with specific fatty infiltration of their RC muscles on MRI taken within 3 months prior to surgical repair
- Subjects with moderate or severe degenerative arthritis of the shoulder under study or any bone abnormalities as confirmed on a radiograph
- Subjects with rheumatologic conditions affecting the shoulder joints or autoimmune disorders, treated with more than 3 corticosteroid injections in the shoulder under study within 1 year of planned surgery, any recent corticosteroid injection in the shoulder or currently receiving oral corticosteroids
- Subjects who are either unwilling or unable to undergo examination with closed MRI.
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: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
Arm A
|
Decision was made by Legal to withhold this information
Decision was made by Legal to withhold this information.
Decision was made by Legal to withhold this information,
|
Eksperimentel: 2
Arm B
|
Decision was made by Legal to withhold this information
Decision was made by Legal to withhold this information.
Decision was made by Legal to withhold this information,
|
Eksperimentel: 3
Arm C
|
Decision was made by Legal to withhold this information
Decision was made by Legal to withhold this information.
Decision was made by Legal to withhold this information,
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Abnormal X-rays, MRIs, CT scans, physical examination of limb, functional evaluations, AE/SAE, vital signs, subject assessment of pain, lab tests
Tidsramme: 1 year
|
1 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Investigator Questionnaire
Tidsramme: 1 year
|
1 year
|
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
1. september 2010
Primær færdiggørelse (Faktiske)
1. februar 2012
Studieafslutning (Faktiske)
1. februar 2012
Datoer for studieregistrering
Først indsendt
2. juli 2009
Først indsendt, der opfyldte QC-kriterier
9. juli 2009
Først opslået (Skøn)
10. juli 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. april 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. april 2012
Sidst verificeret
1. april 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 3202V1-1001
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 .
Kliniske forsøg med Rivning af rotatormanchet
-
Zimmer, GmbHAktiv, ikke rekrutterendeCuff-tear artropatiTyskland, Belgien, Schweiz, Det Forenede Kongerige
-
Consorci Sanitari de TerrassaAfsluttetRotator Cuff River | Rotator Cuff Tear ArthropathySpanien
-
William Beaumont HospitalsAfsluttetRotator Cuff Tear ArthropathyForenede Stater
-
Henry Ford Health SystemSmith & Nephew, Inc.RekrutteringRotator Cuff River | Rotator Cuff Tear ArthropathyForenede Stater
-
Nova Scotia Health AuthorityAktiv, ikke rekrutterende
-
Schulthess KlinikTrukket tilbageRotator Cuff Tear Arthropathy
-
University of UtahAfsluttetRotator Cuff Tear ArthropathyForenede Stater
-
Arthrex, Inc.RekrutteringRotator Cuff Tear ArthropathyForenede Stater
-
Gülçe İrem YalçınkayaAktiv, ikke rekrutterende
-
University of California, San FranciscoAktiv, ikke rekrutterendeRotator Cuff Tear ArthropathyForenede Stater