Trial Outcomes & Findings for Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy (NCT NCT01052844)
NCT ID: NCT01052844
Last Updated: 2014-03-07
Results Overview
The CR was defined as no emetic episodes and no nausea episodes from day 1 to day 5 (0-120h)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
80 participants
Primary outcome timeframe
5 days
Results posted on
2014-03-07
Participant Flow
This was a prospective, double-blind, placebo-controlled study conducted at our institution (Faculdade de Medicina da Fundação ABC and affiliated Hospitals) from April 2009 to April 2010. Patients and personnel involved in the study were blinded to the assigned treatment.
Patients and personnel involved in the study were blinded to the assigned treatment. The study was approved by the ethics committee of our institution. All the patients provided written informed consent. No enrolled participants were excluded from the trial.
Participant milestones
| Measure |
Control Group
Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Placebo:
* Five and four days before chemotherapy (day -5 and day -4): 1x daily
* Three and two days before chemotherapy (day -3 and day -2): 2x daily
* One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
|
Gabapentin
Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Gabapentin 300mg:
* Five and four days before chemotherapy (day -5 and day -4): 1x daily
* Three and two days before chemotherapy (day -3 and day -2): 2x daily
* One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Control Group
Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Placebo:
* Five and four days before chemotherapy (day -5 and day -4): 1x daily
* Three and two days before chemotherapy (day -3 and day -2): 2x daily
* One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
|
Gabapentin
Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Gabapentin 300mg:
* Five and four days before chemotherapy (day -5 and day -4): 1x daily
* Three and two days before chemotherapy (day -3 and day -2): 2x daily
* One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy
Baseline characteristics by cohort
| Measure |
Control Group
n=40 Participants
Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Placebo:
* Five and four days before chemotherapy (day -5 and day -4): 1x daily
* Three and two days before chemotherapy (day -3 and day -2): 2x daily
* One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
|
Gabapentin
n=40 Participants
Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Gabapentin 300mg:
* Five and four days before chemotherapy (day -5 and day -4): 1x daily
* Three and two days before chemotherapy (day -3 and day -2): 2x daily
* One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
53.9 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 daysThe CR was defined as no emetic episodes and no nausea episodes from day 1 to day 5 (0-120h)
Outcome measures
| Measure |
Control Group
n=40 Participants
Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Placebo:
* Five and four days before chemotherapy (day -5 and day -4): 1x daily
* Three and two days before chemotherapy (day -3 and day -2): 2x daily
* One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
|
Gabapentin
n=40 Participants
Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Gabapentin 300mg:
* Five and four days before chemotherapy (day -5 and day -4): 1x daily
* Three and two days before chemotherapy (day -3 and day -2): 2x daily
* One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
|
|---|---|---|
|
Number of Patients With Complete Response During Chemotherapy Course 1
|
17 participants
|
26 participants
|
PRIMARY outcome
Timeframe: 6 daysComplete response during delayed-onset phase was defined as the absence of any episode of nausea or vomiting and no use of rescue medication when occurring during the period from days 2 through 5 after chemotherapy
Outcome measures
| Measure |
Control Group
n=40 Participants
Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Placebo:
* Five and four days before chemotherapy (day -5 and day -4): 1x daily
* Three and two days before chemotherapy (day -3 and day -2): 2x daily
* One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
|
Gabapentin
n=40 Participants
Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Gabapentin 300mg:
* Five and four days before chemotherapy (day -5 and day -4): 1x daily
* Three and two days before chemotherapy (day -3 and day -2): 2x daily
* One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
|
|---|---|---|
|
Number of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1
|
21 participants
|
29 participants
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Gabapentin
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Group
n=40 participants at risk
Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Placebo:
* Five and four days before chemotherapy (day -5 and day -4): 1x daily
* Three and two days before chemotherapy (day -3 and day -2): 2x daily
* One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
|
Gabapentin
n=40 participants at risk
Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)
Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy
Gabapentin 300mg:
* Five and four days before chemotherapy (day -5 and day -4): 1x daily
* Three and two days before chemotherapy (day -3 and day -2): 2x daily
* One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
5/40 • Number of events 5 • Adverse event data were colected from day 1 to day 6 after chemotherapy
|
12.5%
5/40 • Number of events 5 • Adverse event data were colected from day 1 to day 6 after chemotherapy
|
|
Gastrointestinal disorders
Constipation
|
30.0%
12/40 • Number of events 12 • Adverse event data were colected from day 1 to day 6 after chemotherapy
|
45.0%
18/40 • Number of events 18 • Adverse event data were colected from day 1 to day 6 after chemotherapy
|
|
Gastrointestinal disorders
Xerostomia
|
47.5%
19/40 • Number of events 19 • Adverse event data were colected from day 1 to day 6 after chemotherapy
|
57.5%
23/40 • Number of events 23 • Adverse event data were colected from day 1 to day 6 after chemotherapy
|
|
Gastrointestinal disorders
Heartburn
|
25.0%
10/40 • Number of events 10 • Adverse event data were colected from day 1 to day 6 after chemotherapy
|
32.5%
13/40 • Number of events 13 • Adverse event data were colected from day 1 to day 6 after chemotherapy
|
|
Nervous system disorders
Sleepiness
|
47.5%
19/40 • Number of events 19 • Adverse event data were colected from day 1 to day 6 after chemotherapy
|
45.0%
18/40 • Number of events 18 • Adverse event data were colected from day 1 to day 6 after chemotherapy
|
|
Ear and labyrinth disorders
Dizziness
|
32.5%
13/40 • Number of events 13 • Adverse event data were colected from day 1 to day 6 after chemotherapy
|
45.0%
18/40 • Number of events 18 • Adverse event data were colected from day 1 to day 6 after chemotherapy
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place