- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01469182
A Study of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet in Adults With Ragweed Allergies (P05751)
18 januari 2017 uppdaterad av: ALK-Abelló A/S
A 28-Day Study Evaluating the Safety of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet (SCH 39641/MK-3641) Treatment in Ragweed Allergic Adults (Phase 3, Protocol No.P05751)
This study assessed the safety profile of short ragweed (Ambrosia artemisiifolia) in participants with ragweed-induced rhinoconjunctivitis with or without asthma.
The primary objective was to compare treatment-emergent adverse events (AEs) for participants treated with short ragweed allergy immunotherapy tablet (AIT) with those treated with placebo.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
914
Fas
- Fas 3
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Clinical history of physician-diagnosed ragweed-induced allergic rhinoconjunctivitis of 2 years duration or more, with or without asthma
- Must have a positive skin prick test response to Ambrosia artemisiifolia
- Must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value
- Clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor
- Females of child-bearing potential must agree to use medically accepted methods of contraception
Exclusion Criteria:
- Unstable asthma or has experienced an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids in previous 3 months
- Received an immunosuppressive treatment within 3 months
- History of anaphylaxis with cardio-respiratory symptoms.
- History of chronic urticaria or angioedema
- Current severe atopic dermatitis
- Female subject who is breastfeeding, pregnant, or intending to become pregnant
- Has received maintenance doses of immunotherapy with ragweed extract for ≥1 month within the last 5 years
- History of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or self-injectable epinephrine
- Unable to or will not comply with the use of self-injectable epinephrine
- Participating in any other clinical trial
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: SCH 39641 12 Amb a 1-U
12 Units short ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) extract in an AIT, sublingual, once daily.
|
Rapidly dissolving tablet sublingually once daily
Andra namn:
|
Placebo-jämförare: Placebo
Matching placebo tablet, sublingual, once daily.
|
Rapidly dissolving tablet sublingually once daily
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Participants With Treatment-emergent Adverse Events (AEs)
Tidsram: Up to Day 35
|
Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with treatment-emergent AEs were recorded.
An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.
|
Up to Day 35
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Participants Reporting Oral Pruritus.
Tidsram: Up to Day 35
|
Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with oral pruritus were recorded.
All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.
|
Up to Day 35
|
Number of Participants Reporting Ear Pruritus
Tidsram: Up to Day 35
|
Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with ear pruritus were recorded.
All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.
|
Up to Day 35
|
Number of Participants Reporting Throat Irritation
Tidsram: Up to Day 35
|
Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with throat irritation were recorded.
All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.
|
Up to Day 35
|
Number of Participants Reporting Mouth Oedema
Tidsram: Up to Day 35
|
Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with mouth oedema were recorded.
All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.
|
Up to Day 35
|
Number of Participants Reporting Eye Pruritus
Tidsram: Up to Day 35
|
Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with eye pruritus were recorded.
All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.
|
Up to Day 35
|
Number of Participants Reporting Nasal Passage Irritation
Tidsram: Up to Day 35
|
Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with nasal passage irritation were recorded.
All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.
|
Up to Day 35
|
Number of Participants Reporting Skin Pruritus
Tidsram: Up to Day 35
|
Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with skin pruritus were recorded.
All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.
|
Up to Day 35
|
Number of Participants Who Discontinued Due to Treatment-emergent AEs
Tidsram: Up to Day 28
|
Participants were treated with either SCH 39641 12 Amb a 1-U or placebo for 28 days, and the number who discontinued due to treatment emergent-AEs were recorded.
An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.
|
Up to Day 28
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2011
Primärt slutförande (Faktisk)
1 april 2012
Avslutad studie (Faktisk)
1 april 2012
Studieregistreringsdatum
Först inskickad
21 oktober 2011
Först inskickad som uppfyllde QC-kriterierna
9 november 2011
Första postat (Uppskatta)
10 november 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 mars 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 januari 2017
Senast verifierad
1 januari 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P05751
- MK-3641 (Annan identifierare: Merck)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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