- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00115089
7 Day Study of Mast Cell Inhibitor, R926112, in Patients With Symptomatic Seasonal Allergic Rhinitis
9. november 2005 oppdatert av: Rigel Pharmaceuticals
A Phase II Multi-Center, Randomized, Double-Blind, Active and Placebo-Controlled 7 Day Study of Mast Cell Inhibitor, R926112, in Patients With Symptomatic Seasonal Allergic Rhinitis
This is a study of the effectiveness and safety of a new nasal spray for the relief of the symptoms of seasonal allergies.
The agents being compared are: R926112 (a novel anti-allergy medicine), Beconase (beclomethasone dipropionate, an established FDA approved steroid treatment), and an inactive placebo.
The study hypothesis is that R926112 will be superior to placebo at the end of a week of testing and evaluation.
The study does not have the power to determine how R926112 compares to Beconase.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
Seven hundred fifty patients with histories of seasonal allergies will be screened in late summer and early fall at 25 sites across the U.S. Approximately 375 patients, based on severity of symptoms will be randomized among the treatments (150 to R926112, 150 to placebo, 75 to Beconase).
During, and for about 2-3 weeks prior to the study, patients will have to abstain from other anti-allergy medications.
Patients will fill out diary cards two times per day to record their symptoms.
The entire study should take between 2-4 weeks.
Studietype
Intervensjonell
Registrering
375
Fase
- Fase 2
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
12 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Subjects must sign a written informed consent form and assent (if applicable) for study participation.
- Males and females, 12 years of age or older
- Subjects must have a history consistent with seasonal allergic rhinitis (SAR) during the fall pollen season for at least the previous 2 years.
- Subjects must be skin test positive to a relevant fall aeroallergen within the past 12 months with at least a moderate reaction as defined by at least a 5 mm wheal.
- Nasal exam to exclude significant swelling, bleeding, crusting, or polyps
- Subjects receiving immunotherapy must be on a stable maintenance regimen for at least 30 days before screening. Adjustments to the regimen following a brief period of missed injections or the normal reduction in dose due to a vaccine refill does not preclude participation.
- Female subjects of childbearing potential must have negative urine tests for pregnancy at Visits 1 and 2.
- Female subjects of childbearing potential who are sexually active will be expected to use a medically recognized birth control method throughout the study: systemic contraceptive (oral, implant, injection, patch), diaphragm with intravaginal spermicide, cervical cap, vaginal ring, intrauterine device, or condom with spermicide. Females who are not sexually active will be admitted by the discretion of the Investigator. Acceptable birth control will be documented in the subject's case report form.
- Subjects must be willing to adhere to dosing schedules, study visits, and study requirements.
Exclusion Criteria:
- Clinically significant medical conditions (such as hepatic, neurological, hematological, renal, cardiac, gastrointestinal, endocrine, or other major systemic disease), which in the judgment of the Investigator, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult.
- Clinically relevant abnormalities in laboratory results or electrocardiogram (ECG) as determined by the investigator
- Asthma that requires treatment other than with inhaled, short acting beta agonist alone.
- Female subjects who are pregnant, trying to become pregnant, or nursing.
- Nasal structural abnormalities, including large nasal polyps or marked septal deviation that significantly interfere with nasal airflow or nasal surgery within the past year.
- Upper respiratory infection within 3 weeks before the date of Randomization/Visit 2.
- Treatment with any investigational drug in the last 30 days before the date of Randomization/Visit 2.
- History of drug or alcohol abuse that according to the Investigator could interfere with the study.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Subjects unlikely to comply with study procedures, unable to return for study visits, or unlikely to complete the study, or expecting or planning to travel outside the area of the prevalent aeroallergen during the study period.
- History of hypersensitivity to steroids or to the excipients.
- Use of tricyclic antidepressants within the past 30 days prior to date of Randomization/Visit 2.
- Ocular herpes simplex or cataracts present at the time of Screening Visit.
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: Dobbelt
Hva måler studien?
Primære resultatmål
Resultatmål |
---|
Change in total nasal symptom score from baseline over time
|
Sekundære resultatmål
Resultatmål |
---|
Change in individual symptoms
|
Global therapeutic response
|
Quality of life score
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Elliott Grossbard, M.D., Rigel Pharmaceuticals
- Hovedetterforsker: Eli Meltzer, M.D., Allergy and Asthma Medical Group and Research Center, San Diego
- Hovedetterforsker: Harold Nelson, M.D., National Jewish Medical Research Center, Denver
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
1. juli 2005
Studiet fullført
1. september 2005
Datoer for studieregistrering
Først innsendt
20. juni 2005
Først innsendt som oppfylte QC-kriteriene
20. juni 2005
Først lagt ut (Anslag)
21. juni 2005
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. november 2005
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. november 2005
Sist bekreftet
1. november 2005
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Infeksjoner
- Luftveisinfeksjoner
- Sykdommer i luftveiene
- Sykdommer i immunsystemet
- Overfølsomhet, Umiddelbar
- Otorhinolaryngologiske sykdommer
- Respiratorisk overfølsomhet
- Overfølsomhet
- Nesesykdommer
- Rhinitt
- Rhinitt, allergisk
- Rhinitt, Allergisk, Sesongbetinget
- Fysiologiske effekter av legemidler
- Anti-inflammatoriske midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Anti-astmatiske midler
- Luftveismidler
- Beklometason
Andre studie-ID-numre
- C-926112-005A
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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