- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00737191
Opioids With or Without Olanzapine in Treating Patients With Moderate to Severe Cancer Pain
Analgesic Effect of Olanzapine in Cancer Pain: A Double-Blind Randomized Placebo-Controlled Parallel Group Pilot Study
RATIONALE: Opioids lessen pain caused by cancer. It is not yet known whether opioids are more effective when given together with or without olanzapine in treating cancer pain.
PURPOSE: This randomized clinical trial is studying opioids to see how well they work when given together with or without olanzapine in treating patients with moderate to severe cancer pain.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- To assess the analgesic effect of olanzapine when administered in combination with opioids in patients with cancer pain.
- To assess the opiod-sparing effect of olanzapine vs placebo.
- To assess the effect of olanzapine on opioid adverse effects.
OUTLINE: Patients undergo opioid titration with a step 3 opioid to maintain a less than 4/10 level of pain (on a 0-10 numeric pain rating scale) to establish a opioid starting dose. When the pain rating increases, patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive oral opioid and oral placebo once daily for 4 weeks.
- Arm II: Patients receive oral opioid and 2.5 mg oral olanzapine once daily for 4 weeks.
- Arm III: Patients receive oral opioid and 5 mg oral olanzapine once daily for 4 weeks.
Patients undergo quality of life assessments at baseline and three times weekly by questionnaires using a scale from 0-3 and pain assessments periodically by Brief Pain Inventory, Edmonton Symptom Assessment Scale, Linear Analogue Scale Assessments, and Mini-Mental State Examination.
Studietype
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Moderate to severe cancer pain
- Pain score ≥ 7/10 (0-10 numeric pain rating scale)
- Requires strong opioids (step 3) for pain control or are already on stable doses of step 3 opioids
- Opioid induced cognitive dysfunction or cognitive impairment, defined as cognitive disorder not otherwise specified according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) allowed
No nonmalignant pain
- If patient has both malignant and nonmalignant pain, eligibility will be determined by the predominant site of pain
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 3 months
- Normal renal function
- Not pregnant or nursing
- Negative pregnancy test
- Must have a telephone
- Able to complete patient questionnaires alone or with assistance
- No delirium
- No hepatic dysfunction
- No nursing home patients
- No intractable nausea or vomiting
- No true allergy or intolerance to opioids
- No gastrointestinal pathology that influences absorption of opioids
- No drug seeking behavior or recent substance abuse history
- No major depression
- No respiratory compromise
- No evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- No evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
PRIOR CONCURRENT THERAPY:
- More than 1 month since prior radiotherapy, chemotherapy, or radionuclides
- More than 1 month since prior bisphosphonates
- No prior surgery that influences absorption of opioids
- No concurrent therapeutic procedures or treatments that influence pain
- No concurrent active radiation or antineoplastic therapies
- No concurrent retroviral therapies
- No concurrent drugs that interfere with CYP34A, CYP1A2, or CYP2D6
- No concurrent drugs that interfere with morphine metabolism
- No concurrent medications that will influence the disposition of morphine or methadone
- No other concurrent antiemetics, antianxiety, or neuroleptic agents
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Arm I
Patients receive oral opioid and oral placebo once daily for 4 weeks.
|
Gis muntlig
|
|
Eksperimentell: Arm II
Patients receive oral opioid and 2.5 mg oral olanzapine once daily for 4 weeks.
|
Given orally
|
|
Eksperimentell: Arm III
Patients receive oral opioid and 5 mg oral olanzapine once daily for 4 weeks.
|
Given orally
|
Hva måler studien?
Primære resultatmål
Resultatmål |
|---|
|
Two-point pain improvement from baseline (0-10 numeric pain rating scale)
|
Sekundære resultatmål
Resultatmål |
|---|
|
Comparison of active treatment vs placebo
|
|
Effect of olanzapine on opiod adverse effects
|
|
Relationships between endpoints
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Eric E. Prommer, MD, Mayo Clinic
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Smerte
- Nevrologiske manifestasjoner
- Kreftsmerter
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Sentralnervesystemdepressiva
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Antiemetika
- Gastrointestinale midler
- Antipsykotiske midler
- Beroligende midler
- Psykotropiske stoffer
- Serotoninopptakshemmere
- Nevrotransmitter opptakshemmere
- Membrantransportmodulatorer
- Serotoninmidler
- Olanzapin
Andre studie-ID-numre
- CDR0000588630
- P30CA015083 (U.S. NIH-stipend/kontrakt)
- MCS930 (Annen identifikator: Mayo Clinic Cancer Center)
- 07-007571 (Annen identifikator: Mayo Clinic IRB)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
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. .