A Phase 3 interventional study of Olanzapine 10 Mg ORAL TABLET and Olanzapine 5 Mg ORAL TABLET in Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis, sponsored by Rajavithi Hospital. Completed at 1 site in Thailand. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-21.
Sponsored by Rajavithi Hospital · Phase 3, Interventional, and Treatment
To investigate that olanzapine can reduced side effect about nausea and vomiting in women with gynecologic cancers receiving carboplatin-based regimen by using olanzapine and placebo
A double-blind, placebo-controlled, randomized crossover trial
793 studies on the registry are indexed under Vomiting; 99 are open to participants now.
This study's enrollment of 90 is below the median of 103 across 673 interventional studies indexed under Vomiting.
Browse Vomiting studies →Rajavithi Hospital is the lead sponsor of 46 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3
Drug: Olanzapine 10 Mg ORAL TABLET · Drug: Olanzapine 5 Mg ORAL TABLET · Drug: Placebo ORAL TABLET
Olanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3
Drug: Olanzapine 10 Mg ORAL TABLET · Drug: Olanzapine 5 Mg ORAL TABLET · Drug: Placebo ORAL TABLET
Olanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3
Drug: Olanzapine 10 Mg ORAL TABLET · Drug: Olanzapine 5 Mg ORAL TABLET · Drug: Placebo ORAL TABLET
* Olanzapine 10 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) * Olanzapine 10 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4
* Olanzapine 5 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) * Olanzapine 5 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4
* Placebo 1 tab orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) * Placebo 1 tab orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4
Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis
No breakthrough vomiting and no using rescue therapy
Time frame: 5 days after chemotherapeutic administration
Episodes of vomiting
Time frame: 5 days after chemotherapeutic administration
Severity of nausea
Time frame: 5 days after chemotherapeutic administration
Use of rescue drug
using of rescue anti-emetic medication
Time frame: 5 days after chemotherapeutic administration
Quality of life associated with nausea and vomiting measured using Functional Living Index-Emesis (FILE)
Time frame: 5 days after chemotherapeutic administration
Ran from Mar 2020 to primary completion in Jun 2021, 15 months.
Of 37 non-industry phase 3 interventional studies under Vomiting, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's 15 months is below that.
Counting every sponsor, half of 56 studies reached it within 21 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Olanzapine
Rajavithi Hospital