Double-blind, dose-finding study of four intravenous doses of dexamethasone in the prevention of cisplatin-induced acute emesis. Italian Group for Antiemetic Research.

1998 ◽  
Vol 16 (9) ◽  
pp. 2937-2942 ◽  
Keyword(s):  
Dose Finding ◽  
Complete Protection ◽  
Double Blind ◽  
Acute Emesis ◽  
Intention To Treat ◽  
Significant Difference ◽  
Finding Study ◽  
Dose Finding Study ◽  
To Receive ◽  
Different Doses

PURPOSE A 5-hydroxytryptamine 3 (5-HT3) receptor antagonist plus dexamethasone is the most efficacious antiemetic prophylactic treatment for the prevention of cisplatin-induced acute emesis, but the optimal intravenous (i.v.) dose of dexamethasone is unknown. This prompted us to perform a multicenter, randomized, double-blind, dose-finding study that compared four different doses of dexamethasone. PATIENTS AND METHODS Patients were randomized to receive dexamethasone, either 4, 8, 12, or 20 mg, administered by 15-minute i.v. infusion 45 minutes before cisplatin. Ondansetron 8 mg was added to dexamethasone and was administered i.v. 30 minutes before cisplatin. From March 1996 to July 1997, 531 patients were enrolled onto the study and 530 were assessable according to the intention-to-treat principle (133 patients received 4 mg; 136 patients, 8 mg; 130 patients, 12 mg; and 131 patients, 20 mg of dexamethasone). RESULTS Complete protection from acute vomiting and nausea was achieved by 69.2% and 60.9% of patients, respectively, who received 4 mg of dexamethasone, by 69.1% and 61.0% of those who received 8 mg, by 78.5% and 66.9% of those who received 12 mg, and by 83.2% and 71.0% of those who received 20 mg of dexamethasone. Complete protection from vomiting was significantly superior in patients who received 20 mg compared with those who received 4 and 8 mg of dexamethasone (P < .005) and was superior, but not significantly, compared with those who received 12 mg. Complete protection from nausea was superior, but not significantly, in patients who received 20 mg of dexamethasone. Multifactorial analysis confirmed these results. Antiemetic treatment was well tolerated, and no significant difference was found among the four groups in the incidence of adverse events. CONCLUSION A 20-mg single i.v. dose of dexamethasone should be considered the most efficacious prophylactic dose for the prevention of cisplatin-induced acute emesis.

Randomized, Double-Blind, Dose-Finding Study of Dexamethasone in Preventing Acute Emesis Induced by Anthracyclines, Carboplatin, or Cyclophosphamide:

2004 ◽  
Vol 22 (4) ◽  
pp. 725-729 ◽  
Author(s):  
Keyword(s):  
Single Dose ◽  
Dose Finding ◽  
Complete Protection ◽  
Double Blind ◽  
Acute Emesis ◽  
Intention To Treat ◽  
Finding Study ◽  
Dose Finding Study ◽  
To Receive ◽  
Different Doses

Purpose Different doses and schedules of dexamethasone, combined with a 5-HT3 antagonist, are used to prevent acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide. Therefore, we planned a randomized, double-blind, dose finding study aimed to identify the preferred dose and schedule of dexamethasone. Patients and Methods All consecutive chemotherapy-naive patients enrolled onto study were randomly assigned to receive for the prevention of acute emesis, during the first 24 hours, one of the following dexamethasone regimens, in combination with ondansetron 8 mg intravenously (IV): for arm A, 8 mg IV before chemotherapy plus 4 mg orally every 6 hours for four doses, starting at the same time of the chemotherapy; for arm B, 24 mg IV single dose before chemotherapy; and for arm C, 8 mg IV single dose before chemotherapy. All patients received from day 2 to 5 oral dexamethasone 4 mg bid. Results A total of 587 patients were enrolled, and 585 were assessed according to the intention-to-treat principle (195 patients in each arm). The rate of complete protection from acute vomiting and nausea, respectively, was not significantly different among the three groups (arm A, 84.6% and 66.7%; arm B, 83.6% and 56.9%; arm C, 89.2% and 61.0%), nor was the rate of complete protection from delayed vomiting and nausea, respectively (arm A, 81.0% and 46.7%; arm B, 81.3% and 45.1%; arm C, 79.8% and 46.1%). The incidence of delayed vomiting and nausea was strictly dependent on the presence of acute vomiting and nausea. Adverse events were mild and not significantly different among the three groups. Conclusion Dexamethasone 8 mg single dose IV before chemotherapy, in combination with a 5-HT3 antagonist, should be considered the preferred dose to prevent acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide.

The effect of several doses of oral tocainide HC1 on tinnitus: a dose-finding study

1984 ◽  
Vol 98 (S9) ◽  
pp. 257-258
Author(s):  
Jan H. Hulshof ◽  
Pieter Vermey
Keyword(s):  
Oral Administration ◽  
Controlled Trial ◽  
Dose Finding ◽  
Double Blind ◽  
Considerable Research ◽  
Finding Study ◽  
Dose Finding Study ◽  
Single Blind ◽  
Different Doses

From all methods of the treatment of tinnitus, medical, masking, surgery, electrical stimulation and psychological, we believe a reliable medical treatment would be preferable because it is easy to apply. An immense variety of drugs have been used for the treatment of tinnitus (Vernon, 1977). The most reliable drugs so far on tinnitus are intravenous procaine and lidocaine (Bárány, 1935; Lewy, 1937; Melding et al., 1978; Martin and Colman, 1980; Israel et al., 1982). The fact that these drugs cannot be given orally because of the poor biological availability after oral administration, is a great disadvantage. In view of the important pharmaco-therapeutic role of lidocaine as an anti-arrhythmic drug, considerable research has been devoted to drugs with comparable anti-arrhythmic properties but permitting oral administration. This work produced tocainide (Smith, 1981), which showed a certain degree of effect on tinnitus as well (Emmett and Shea, 1980; Cathcart, 1982). Before starting a randomized double-blind controlled trial to assess the effect on tinnitus of tocainide, we studied the effect of several doses of tocainide HCl on tinnitus in order to select an appropriate dosage. Nineteen patients with obstructive tinnitus of various aetiologies were admitted to the study. There were 10 women and nine men. Their mean age was 54 years (range 22–67 years). Tocainide was administered in five different doses in a single-blind controlled trial. To be able to judge the effect under steady conditions, each dose was given for four days, as shown in Table I. On the fourth day of each period the patients had to record the degree of impediment caused by the tinitus on a six-point scale (Table II). They were also asked to report all sideeffects.

scholarly journals Double-blind, randomised, placebo-controlled, dose-finding study of oral ibandronate in patients with metastatic bone disease

1999 ◽  
Vol 10 (3) ◽  
pp. 311-316 ◽  
Author(s):  
R.E. Coleman ◽  
O.P. Purohit ◽  
C. Black ◽  
J.J. F. Vinholes ◽  
K. Schlosser ◽  
...  
Keyword(s):  
Bone Disease ◽  
Metastatic Bone Disease ◽  
Dose Finding ◽  
Double Blind ◽  
Finding Study ◽  
Dose Finding Study

Prevention of cisplatin-induced emesis: a double-blind multicenter randomized crossover study comparing ondansetron and ondansetron plus dexamethasone.

1991 ◽  
Vol 9 (4) ◽  
pp. 675-678 ◽  
Author(s):  
F Roila ◽  
M Tonato ◽  
F Cognetti ◽  
E Cortesi ◽  
G Favalli ◽  
...  
Keyword(s):  
Side Effects ◽  
Crossover Study ◽  
Receptor Antagonist ◽  
Treatment Preference ◽  
Complete Protection ◽  
Double Blind ◽  
Significant Difference ◽  
Antiemetic Activity ◽  
To Receive ◽  
Randomized Crossover Study

Ondansetron (OND) is a new 5-HT3 receptor antagonist that give complete protection from emesis/nausea in approximately 50% of cisplatin (CDDP)-treated patients. To evaluate if dexamethasone (DEX) added to OND increases antiemetic efficacy, we carried out a double-blind randomized crossover study to compare the antiemetic activity of OND with OND plus DEX. One hundred two chemotherapy-naive patients (44 women and 58 men) scheduled to receive CDDP chemotherapy at doses greater than or equal to 50 mg/m2 entered the study. Eighty-nine patients completed both cycles with the following results: complete protection from emesis/nausea was obtained in 57/59 patients (64.0%/66.3%) with OND and in 81/79 (91.0%/88.8%) with OND plus DEX (P = .0005/P = .0021). At the end of the study, 53% of the patients expressed a treatment preference, and of these, 74% chose OND plus DEX compared with 26% who preferred OND alone, a statistically significant difference (P less than .003). Side effects were very mild and not significantly different between the two treatments. We conclude that OND plus DEX is more efficacious than OND in protecting patients from CDDP-induced emesis and nausea.

Deramciclane in the treatment of generalized anxiety disorder: A placebo-controlled, double-blind, dose-finding study

2005 ◽  
Vol 15 (6) ◽  
pp. 617-623 ◽  
Author(s):  
Hannu Naukkarinen ◽  
Roope Raassina ◽  
Jukka Penttinen ◽  
Antti Ahokas ◽  
Riitta Jokinen ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Generalized Anxiety Disorder ◽  
Dose Finding ◽  
Generalized Anxiety ◽  
Double Blind ◽  
Finding Study ◽  
Dose Finding Study
Sign in / Sign up

Export Citation Format

Share Document