- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00489424
Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an Intravenous (i.v.) Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone Mass
15. februar 2011 oppdatert av: Novartis Pharmaceuticals
A Randomized, Multicenter, Double-blind, Double-dummy, Parallel-group Study of Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an i.v. Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone Mass
This study will evaluate the efficacy of acetaminophen or fluvastatin in reducing the rate of occurrence and the severity of post dose symptoms that may occur during the 3 day period following a zoledronic acid infusion in post menopausal women with low bone mass.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
793
Fase
- Fase 4
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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New Jersey
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Http://www.osteoporosisclinicalresearch.com, New Jersey, Forente stater
- Refer to the E-portal link for ZOL446HUS136
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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
45 år til 79 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- Postmenopausal women greater than or equal to 45 and less than or equal to 79 years of age at randomization
- Women who are clinically indicated for treatment with Bisphosphonates for osteopenia or osteoporosis with a documented central (spine or hip) Bone Mineral Density T Score less than or equal to 1.5
Exclusion Criteria:
- Any prior treatment with intravenous Bisphosphonates
- Oral treatment with Bisphosphonates for more than 8 weeks or within 6 months prior to the screening visit
- Patients who are taking, and are unwilling or unable to stop taking, certain medications
- Patients who require anticoagulant therapy
- Patients with a known hypersensitivity to ibuprofen, ACET, bisphosphonates, statins or with allergies manifested by attacks of asthma, urticaria or acute rhinitis following
- Proteinuria (protein detected on a urine dipstick) greater than or equal to 2+ at screening
- Protocol specific laboratory values that fall out of range for this study
- Ongoing infection (oral body temperature greater than or equal to 37.5C (99.5°F),chronic febrile disease or fever of unknown origin at screening or randomization
- Active dental infection, unhealed dental extraction or planned oral surgery within 3 months after randomization
- History of iritis, uveitis or chronic conjunctivitis
- History of hypoparathyroidism, hyperparathyroidism or Paget's Disease
- Partial or total removal of parathyroid or thyroid gland
- History of malignancy of any organ system, treated or untreated, within the past 1 year whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
- Treatment with an investigational drug within the previous 30 days of screening
- Patients with any medical or psychiatric condition which, in the opinion of the Principal Investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol, or any patient who the Principal Investigator thinks should not participate in the study for any reason, including current drug or alcohol abuse
Other protocol-defined inclusion/exclusion criteria may apply
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
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Acetaminophen
2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v.
infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
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Eksperimentell: Fluvastatin
2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v.
infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
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Placebo komparator: Placebo
2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.
Tidsramme: 0 - 3 days
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Clinically significant increase in oral body temperature or used rescue medication ibuprofen >= 1 time during the 3-day period after i.v.
infusion of zoledronic acid 5 mg.
A clinically significant increase in body temperature was defined as an increase of at least 1 degree Celsius from baseline and a mean oral body temperature reading of at least 38.5 degrees Celsius occurring at least once during the 3-day treatment period.
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0 - 3 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.
Tidsramme: 0 - 3 days
|
Clinically significant increase in oral body temperature >= 1 time during the 3-day period after i.v.
infusion of zoledronic acid 5 mg.
A clinically significant increase in body temperature was defined as an increase of at least 1 degree Celsius from baseline and a mean oral body temperature reading of at least 38.5 degrees Celsius occurring at least once during the 3-day treatment period.
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0 - 3 days
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Proportion of Patients Who Used Rescue Medication.
Tidsramme: 0 - 3 days
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Patients that took rescue medication >= 1 time during the 3-day period after i.v.
infusion of zoledronic acid 5 mg.
Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.
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0 - 3 days
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Number of Rescue Medication Tablets Taken
Tidsramme: 0 - 3 days
|
Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.
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0 - 3 days
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Time to First Rescue Medication After Infusion of Zoledronic Acid 5 mg.
Tidsramme: 0 - 3 days
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Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication.
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0 - 3 days
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Proportion of Patients With a Major Increase (Worsening) in Severity of Questionnaire Symptoms.
Tidsramme: 0 - 3 days
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A major increase (worsening) in severity was defined as an increase in severity of 2 units or more from baseline at least once during the 3 days immediately following i.v.
infusion of zoledronic acid 5 mg.
The severity of the symptom was evaluated using a 4-point categorical scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe).
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0 - 3 days
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Proportion of Patients Reporting Severe Questionnaire Symptoms.
Tidsramme: 0 - 3 days
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A severe questionnaire symptom was defined as experiencing a severe specified symptom (feeling feverish, experiencing headaches, having aches and pains of muscles and joints) at least once post-baseline.
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0 - 3 days
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Change From Baseline in Visual Analog Scale (VAS) Measurement of Symptom Severity
Tidsramme: 0 - 3 days
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Effect on severity of symptoms following i.v.
infusion of zoledronic acid 5 mg.
The VAS is a 100-mm linear visual analog scale (0 = no symptoms to 100 = severe symptoms).
The baseline VAS measurement was defined as the VAS measurement recorded prior to the infusion.
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0 - 3 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.
Hjelpsomme linker
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. juni 2007
Primær fullføring (Faktiske)
1. desember 2007
Studiet fullført (Faktiske)
1. desember 2007
Datoer for studieregistrering
Først innsendt
19. juni 2007
Først innsendt som oppfylte QC-kriteriene
20. juni 2007
Først lagt ut (Anslag)
21. juni 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
18. februar 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. februar 2011
Sist bekreftet
1. februar 2011
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CZOL446HUS136
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