Trial Outcomes & Findings for Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy (NCT NCT00880191)
NCT ID: NCT00880191
Last Updated: 2016-07-06
Results Overview
Complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
430 participants
Primary outcome timeframe
Days 2 through 6
Results posted on
2016-07-06
Participant Flow
430 patients were enrolled on this study. There are 17 cancelled patients, 7 on the gabapentin arm and 10 on the placebo arm.
Participant milestones
| Measure |
Gabapentin
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
\> dexamethasone: Given orally
\> gabapentin: Given orally
|
Placebo
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
\> dexamethasone: Given orally
\> placebo: Given orally
|
|---|---|---|
|
Overall Study
STARTED
|
207
|
206
|
|
Overall Study
Available for Primary Endpoint Analysis
|
207
|
206
|
|
Overall Study
COMPLETED
|
194
|
198
|
|
Overall Study
NOT COMPLETED
|
13
|
8
|
Reasons for withdrawal
| Measure |
Gabapentin
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
\> dexamethasone: Given orally
\> gabapentin: Given orally
|
Placebo
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
\> dexamethasone: Given orally
\> placebo: Given orally
|
|---|---|---|
|
Overall Study
Refused further treatment
|
4
|
1
|
|
Overall Study
Adverse Event
|
8
|
6
|
|
Overall Study
Hospitalization/efficacy
|
1
|
1
|
Baseline Characteristics
Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy
Baseline characteristics by cohort
| Measure |
Gabapentin
n=207 Participants
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.\> dexamethasone: Given orally\> gabapentin: Given orally
|
Placebo
n=206 Participants
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.\> dexamethasone: Given orally\> placebo: Given orally
|
Total
n=413 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<50 Years
|
57 participants
n=5 Participants
|
58 participants
n=7 Participants
|
115 participants
n=5 Participants
|
|
Age, Customized
>=50 Years
|
150 participants
n=5 Participants
|
148 participants
n=7 Participants
|
298 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
290 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
207 participants
n=5 Participants
|
206 participants
n=7 Participants
|
413 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 2 through 6Complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.
Outcome measures
| Measure |
Gabapentin
n=207 Participants
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
\> dexamethasone: Given orally
\> gabapentin: Given orally
|
Placebo
n=206 Participants
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
\> dexamethasone: Given orally
\> placebo: Given orally
|
|---|---|---|
|
Comparison of Percentage of Complete Responders
Response Days 2-6: Yes
|
46.9 percentage of participants
|
40.8 percentage of participants
|
|
Comparison of Percentage of Complete Responders
Response Days 2-6: No
|
53.1 percentage of participants
|
59.2 percentage of participants
|
SECONDARY outcome
Timeframe: Days 2-6The primary analysis described above was repeated using a slightly different alternate definition of complete response: no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale (0 - 10 (As bad as it could be)), and no rescue agents.
Outcome measures
| Measure |
Gabapentin
n=207 Participants
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
\> dexamethasone: Given orally
\> gabapentin: Given orally
|
Placebo
n=206 Participants
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
\> dexamethasone: Given orally
\> placebo: Given orally
|
|---|---|---|
|
Complete Response
Response Days 2-6: No
|
56 percentage of participants
|
60.7 percentage of participants
|
|
Complete Response
Response Days 2-6: Yes
|
44 percentage of participants
|
39.3 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1 through 6The percentages of complete responders on day 1, vs. days 1 through 6 vs. days 2 through 6 will be compared between arms. Complete response being defined as no emetic episodes and no use of rescue therapy. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.
Outcome measures
| Measure |
Gabapentin
n=207 Participants
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
\> dexamethasone: Given orally
\> gabapentin: Given orally
|
Placebo
n=206 Participants
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
\> dexamethasone: Given orally
\> placebo: Given orally
|
|---|---|---|
|
Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6.
Response Day 1: No
|
32.4 percentage of participants
|
33.5 percentage of participants
|
|
Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6.
Response Day 1: Yes
|
67.6 percentage of participants
|
66.5 percentage of participants
|
|
Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6.
Response Day 1-6: No
|
60.4 percentage of participants
|
63.6 percentage of participants
|
|
Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6.
Response Day 1-6: Yes
|
39.6 percentage of participants
|
36.4 percentage of participants
|
|
Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6.
Response Day 2-6: No
|
62.3 percentage of participants
|
65 percentage of participants
|
|
Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6.
Response Day 2-6: Yes
|
37.7 percentage of participants
|
35 percentage of participants
|
SECONDARY outcome
Timeframe: Days1 through 6The percentage of patients experiencing emetic episodes and the percentage needing rescue agents was compared between groups.
Outcome measures
| Measure |
Gabapentin
n=207 Participants
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
\> dexamethasone: Given orally
\> gabapentin: Given orally
|
Placebo
n=206 Participants
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
\> dexamethasone: Given orally
\> placebo: Given orally
|
|---|---|---|
|
Comparison of the Percentage of Patients Experiencing Emetic Episodes and the Percentage Needing Rescue Agents
Emetic Status: No
|
70 percentage of participants
|
70 percentage of participants
|
|
Comparison of the Percentage of Patients Experiencing Emetic Episodes and the Percentage Needing Rescue Agents
Rescue Agent Status: No
|
55 percentage of participants
|
47 percentage of participants
|
|
Comparison of the Percentage of Patients Experiencing Emetic Episodes and the Percentage Needing Rescue Agents
Rescue Agent Status: Yes
|
45 percentage of participants
|
53 percentage of participants
|
|
Comparison of the Percentage of Patients Experiencing Emetic Episodes and the Percentage Needing Rescue Agents
Emetic Status: Yes
|
30 percentage of participants
|
30 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1 through 6The sum of the daily distress questions as well as the individual daily responses from the Nausea and Vomiting Diary (NVD) on a 0-10 scale (Lower score is better) will be compared.
Outcome measures
| Measure |
Gabapentin
n=207 Participants
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
\> dexamethasone: Given orally
\> gabapentin: Given orally
|
Placebo
n=206 Participants
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
\> dexamethasone: Given orally
\> placebo: Given orally
|
|---|---|---|
|
Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses
NVD Nausea Distress Day 1
|
1.1 units on a scale
Standard Deviation 2.3
|
1.2 units on a scale
Standard Deviation 2.2
|
|
Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses
NVD Nausea Distress Day 2
|
0.9 units on a scale
Standard Deviation 1.9
|
1.1 units on a scale
Standard Deviation 1.7
|
|
Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses
NVD Nausea Distress Day 3
|
0.9 units on a scale
Standard Deviation 1.9
|
1.2 units on a scale
Standard Deviation 2.2
|
|
Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses
NVD Nausea Distress Day 4
|
0.7 units on a scale
Standard Deviation 1.6
|
1.1 units on a scale
Standard Deviation 1.9
|
|
Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses
NVD Nausea Distress Day 5
|
0.9 units on a scale
Standard Deviation 1.9
|
1.1 units on a scale
Standard Deviation 1.8
|
|
Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses
NVD Nausea Distress Day 6
|
0.8 units on a scale
Standard Deviation 1.8
|
0.9 units on a scale
Standard Deviation 1.7
|
|
Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses
NVD Nausea Distress Sum Days 1-6
|
5.1 units on a scale
Standard Deviation 8.0
|
6.4 units on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Days 1 through 6Population: 203 patients in Gabapentin arm and 201 patients in Placebo arm submitted the data for this endpoint.
Level of satisfaction for the control of nausea with the mean severity of nausea over the six days in the diary (on a 0 - 10 scale, higher the better) as well as the nausea subscale on the Functional Living Index - Emesis (FLIE) questionnaire ( 1-7 scale, lower the better)
Outcome measures
| Measure |
Gabapentin
n=203 Participants
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
\> dexamethasone: Given orally
\> gabapentin: Given orally
|
Placebo
n=201 Participants
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
\> dexamethasone: Given orally
\> placebo: Given orally
|
|---|---|---|
|
Level of Satisfaction for the Control of Nausea.
Satisfaction Nausea Control (0-10 scale)
|
8.3 units on a scale
Standard Deviation 2.8
|
8.1 units on a scale
Standard Deviation 2.9
|
|
Level of Satisfaction for the Control of Nausea.
FLIE Nausea Subscale Day 6
|
2.8 units on a scale
Standard Deviation 1.0
|
2.9 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Days 1 through 6Daily complete response is defined as no emetic episodes and no use of rescue therapy.
Outcome measures
| Measure |
Gabapentin
n=207 Participants
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
\> dexamethasone: Given orally
\> gabapentin: Given orally
|
Placebo
n=206 Participants
Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
\> dexamethasone: Given orally
\> placebo: Given orally
|
|---|---|---|
|
Comparison of Daily Complete Response Endpoints
Response Day 3: Yes
|
77.8 percentage of participants
|
65.5 percentage of participants
|
|
Comparison of Daily Complete Response Endpoints
Response Day 4: No
|
19.3 percentage of participants
|
30.1 percentage of participants
|
|
Comparison of Daily Complete Response Endpoints
Response Day 1: No
|
32.4 percentage of participants
|
33.5 percentage of participants
|
|
Comparison of Daily Complete Response Endpoints
Response Day 1: Yes
|
67.6 percentage of participants
|
66.5 percentage of participants
|
|
Comparison of Daily Complete Response Endpoints
Response Day 2: No
|
26.6 percentage of participants
|
36.4 percentage of participants
|
|
Comparison of Daily Complete Response Endpoints
Response Day 2: Yes
|
73.4 percentage of participants
|
63.6 percentage of participants
|
|
Comparison of Daily Complete Response Endpoints
Response Day 3: No
|
22.2 percentage of participants
|
34.5 percentage of participants
|
|
Comparison of Daily Complete Response Endpoints
Response Day 4: Yes
|
80.7 percentage of participants
|
69.9 percentage of participants
|
|
Comparison of Daily Complete Response Endpoints
Response Day 5: No
|
32.9 percentage of participants
|
34.0 percentage of participants
|
|
Comparison of Daily Complete Response Endpoints
Response Day 5: Yes
|
67.1 percentage of participants
|
66.0 percentage of participants
|
|
Comparison of Daily Complete Response Endpoints
Response Day 6: No
|
28.0 percentage of participants
|
31.6 percentage of participants
|
|
Comparison of Daily Complete Response Endpoints
Response Day 6: Yes
|
72.0 percentage of participants
|
68.4 percentage of participants
|
Adverse Events
Gabapentin
Serious events: 0 serious events
Other events: 95 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gabapentin
n=207 participants at risk
gabapentin: Given orally
|
Placebo
n=206 participants at risk
placebo: Given orally
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/207
|
0.49%
1/206 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.48%
1/207 • Number of events 1
|
0.00%
0/206
|
|
Eye disorders
Vision blurred
|
0.48%
1/207 • Number of events 1
|
0.00%
0/206
|
|
Gastrointestinal disorders
Constipation
|
0.97%
2/207 • Number of events 2
|
0.97%
2/206 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
3/207 • Number of events 3
|
0.49%
1/206 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
6/207 • Number of events 6
|
1.5%
3/206 • Number of events 3
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/207
|
0.49%
1/206 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
0.48%
1/207 • Number of events 1
|
0.00%
0/206
|
|
Gastrointestinal disorders
Nausea
|
2.4%
5/207 • Number of events 5
|
0.49%
1/206 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
3/207 • Number of events 3
|
1.5%
3/206 • Number of events 3
|
|
General disorders
Edema limbs
|
9.2%
19/207 • Number of events 19
|
8.7%
18/206 • Number of events 18
|
|
General disorders
Fatigue
|
0.97%
2/207 • Number of events 2
|
0.49%
1/206 • Number of events 1
|
|
General disorders
Localized edema
|
1.4%
3/207 • Number of events 3
|
4.4%
9/206 • Number of events 9
|
|
General disorders
Pain
|
0.00%
0/207
|
0.49%
1/206 • Number of events 1
|
|
Infections and infestations
Device related infection
|
0.48%
1/207 • Number of events 1
|
0.00%
0/206
|
|
Infections and infestations
Pneumonia
|
0.00%
0/207
|
0.49%
1/206 • Number of events 1
|
|
Infections and infestations
Skin infection
|
0.00%
0/207
|
0.49%
1/206 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.48%
1/207 • Number of events 1
|
0.00%
0/206
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/207
|
0.49%
1/206 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.48%
1/207 • Number of events 1
|
0.00%
0/206
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/207
|
0.49%
1/206 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.00%
0/207
|
0.49%
1/206 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/207
|
0.49%
1/206 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
6.3%
13/207 • Number of events 13
|
11.2%
23/206 • Number of events 23
|
|
Nervous system disorders
Depressed level of consciousness
|
7.7%
16/207 • Number of events 16
|
8.3%
17/206 • Number of events 17
|
|
Nervous system disorders
Dizziness
|
27.5%
57/207 • Number of events 58
|
28.6%
59/206 • Number of events 59
|
|
Nervous system disorders
Headache
|
2.4%
5/207 • Number of events 5
|
1.5%
3/206 • Number of events 3
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.48%
1/207 • Number of events 1
|
0.00%
0/206
|
|
Nervous system disorders
Speech disorder
|
0.48%
1/207 • Number of events 1
|
0.00%
0/206
|
|
Nervous system disorders
Syncope
|
0.00%
0/207
|
0.49%
1/206 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
0.48%
1/207 • Number of events 1
|
0.00%
0/206
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/207
|
0.49%
1/206 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.48%
1/207 • Number of events 1
|
0.00%
0/206
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
0.00%
0/207
|
0.49%
1/206 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/207
|
0.49%
1/206 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.48%
1/207 • Number of events 1
|
0.00%
0/206
|
|
Vascular disorders
Thrombosis
|
0.00%
0/207
|
0.49%
1/206 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place