A Randomized Double-Blind, Double-Dummy, Multicenter Trial of Azasetron versus Ondansetron to Evaluate Efficacy and Safety in the Prevention of Delayed Nausea and Vomiting Induced by Chemotherapy

Purpose We examined the efficacy and safety of thalidomide (THD) for the prevention of delayed nausea and vomiting in patients who received highly emetogenic chemotherapy (HEC). Patients and Methods In a randomized, double-blind, active-controlled, phase III trial, chemotherapy-naive patients with cancer who were scheduled to receive HEC that contained cisplatin or cyclophosphamide-doxorubicin/epirubincin ≥ 50 mg/m2 regimens were randomly assigned to a THD group (100 mg twice daily on days 1 to 5) or placebo group, both with palonosetron (0.25 mg on day 1) and dexamethasone (12 mg on day 1; 8 mg on days 2 to 4). Primary end point was complete response to vomiting—no emesis or use of rescue medication—in the delayed phase (25 to 120 h). Nausea and anorexia on days 1 to 5 were evaluated by the 4-point Likert scale (0, no symptoms; 3, severe). Quality of life was assessed by the European Organization for Research and Treatment of Cancer QLQ-C30 version 3 questionnaire on days −1 and 6. Results Of 656 patients, 638 were evaluable: 317 in the THD group and 321 in the control group. Compared with placebo, delayed and overall (0 to 120 h) complete response rates to vomiting were significantly higher with THD: 76.9% versus 61.7% ( P < .001) and 66.1% versus 53.3% ( P = .001), respectively. Rates of no nausea were also higher in the THD group (delayed: 47.3% v 33.3%; P < .001; overall: 41% v 29.6%; P = .003), and mean scores of anorexia were lower overall (0.44 ± 0.717 v 0.64 ± 0.844; P = .003). Adverse effects were mild to moderate. The THD group had increased sedation, dizziness, constipation, and dry mouth, but experienced better quality of life after chemotherapy. Conclusion Thalidomide combined with palonosetron and dexamethasone significantly improved HEC-induced delayed nausea and vomiting prevention in chemotherapy-naive patients.

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Poster 50: Efficacy and Safety of NT 201 (Botulinum Neurotoxin Type A Free From Complexing Proteins) for the Treatment of Blepharospasm: Results of a Double-blind, Placebo-controlled, Randomized, Multicenter Trial

PM&R ◽

10.1016/j.pmrj.2010.07.081 ◽

2010 ◽

Vol 2 ◽

pp. S29-S30

Author(s):

Susanne Grafe ◽

Joseph Jankovic ◽

Angelika Hanschmann

Keyword(s):

Botulinum Neurotoxin ◽

Type A ◽

Multicenter Trial ◽

Efficacy And Safety ◽

Double Blind ◽

Double Blind Placebo ◽

Botulinum Neurotoxin Type A ◽

Complexing Proteins ◽

Nt 201

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RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER TRIAL OF EFFICACY AND SAFETY OF GRANULOCYTE COLONY-STIMULATING FACTOR IN LIVER TRANSPLANT RECIPIENTS1

Transplantation Journal ◽

10.1097/00007890-199911150-00014 ◽

1999 ◽

Vol 68 (9) ◽

pp. 1298-1304 ◽

Cited By ~ 30

Author(s):

Drew J. Winston ◽

Preston F. Foster ◽

Kenneth A. Somberg ◽

Ronald W. Busuttil ◽

Marlon F. Levy ◽

...

Keyword(s):

Liver Transplant ◽

Multicenter Trial ◽

Granulocyte Colony Stimulating Factor ◽

Efficacy And Safety ◽

Colony Stimulating Factor ◽

Double Blind ◽

Stimulating Factor

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Efficacy and safety of ginsenoside-Rd for acute ischaemic stroke: a randomized, double-blind, placebo-controlled, phase II multicenter trial

European Journal of Neurology ◽

10.1111/j.1468-1331.2009.02534.x ◽

2009 ◽

Vol 16 (5) ◽

pp. 569-575 ◽

Cited By ~ 64

Author(s):

X. Liu ◽

J. Xia ◽

L. Wang ◽

Y. Song ◽

J. Yang ◽

...

Keyword(s):

Ischaemic Stroke ◽

Phase Ii ◽

Acute Ischaemic Stroke ◽

Multicenter Trial ◽

Efficacy And Safety ◽

Double Blind ◽

Double Blind Placebo ◽

Ginsenoside Rd

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The efficacy and safety study of dietary supplement PURIAM110 on non-insulin taking Korean adults in the stage of pre-diabetes and diabetes mellitus: protocol for a randomized, double-blind, placebo-controlled, and multicenter trial-pilot study

Trials ◽

10.1186/1745-6215-12-38 ◽

2011 ◽

Vol 12 (1) ◽

Cited By ~ 2

Author(s):

Sunju Park ◽

Jeong-Su Park ◽

Hoyeon Go ◽

Bo-Hyoung Jang ◽

Yongcheol Shin ◽

...

Keyword(s):

Diabetes Mellitus ◽

Pilot Study ◽

Dietary Supplement ◽

Multicenter Trial ◽

Efficacy And Safety ◽

Safety Study ◽

Double Blind ◽

Double Blind Placebo ◽

Korean Adults

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Ramosetron hydrochloride for the prevention of cancer chemotherapy induced nausea and vomiting: The Indian experience

South Asian Journal of Cancer ◽

10.4103/2278-330x.130466 ◽

2014 ◽

Vol 03 (02) ◽

pp. 132-137 ◽

Cited By ~ 3

Author(s):

Jayesh J. Sanmukhani ◽

Prafulla Pawar ◽

Ravindra Mittal

Keyword(s):

Adverse Events ◽

Cancer Chemotherapy ◽

Complete Response ◽

Daily Basis ◽

Nausea And Vomiting ◽

Efficacy And Safety ◽

Open Label ◽

Entire Study ◽

Ondansetron Hydrochloride ◽

Delayed Nausea

Abstract Background: Despite the advent of 5-HT 3 antagonists, control of delayed gastrointestinal adverse events with cancer chemotherapy is still not optimal. This open label, active controlled, multicentric clinical trial was undertaken to assess the comparative efficacy and safety of ramosetron with ondansetron for the prevention of acute and delayed nausea and vomiting associated with emetogenic cancer chemotherapy in adult patients in India. Materials and Methods: Enrolled patients received treatment with ramosetron hydrochloride 0.1 mg or ondansetron hydrochloride 4 mg tablets once daily in the morning for 5 days starting 1 h before the start of chemotherapy. Severity grades of nausea and vomiting were recorded on a daily basis for a period of 5 days and complete response rate (CRR) and effective rate (ER) were calculated. Clinical adverse events were recorded and hematological and biochemical investigations were performed for safety assessment. Results: A total of 114 patients in ramosetron group and 100 patients in ondansetron group completed the study and were eligible for efficacy and safety analysis. CRR and ERs show that while ramosetron is non-inferior to ondansetron in the control of early nausea and vomiting (occurring during the first 24 h) after the treatment with emetogenic chemotherapy, it is superior to ondansetron in the control of delayed nausea and vomiting (occurring after the first 24 h). The proportion of patients achieving a cumulative complete response (for the entire study period) is significantly greater in ramosetron group as compared to ondansetron group (27.2% vs. 7.0%; P < 0.001). Ramosetron was well tolerated by all the study participants. Conclusions: Ramosetron is significantly more effective than ondansetron for the control of delayed nausea and vomiting induced by emetogenic cancer chemotherapy.

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