Trial Outcomes & Findings for Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis (NCT NCT00432835)
NCT ID: NCT00432835
Last Updated: 2012-12-03
Results Overview
Likert Scale 0-4 (low-high) using a patient reported outcomes tool
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
58 participants
Primary outcome timeframe
Study Day 0 (Baseline), Day 3, Day 7
Results posted on
2012-12-03
Participant Flow
Patients seeking temporary gastric electric stimulator devices for drug-refractory gastroparesis between August 2005 and October 2006 who met the inclusion criteria and did not have any of the exclusion criteria were offered access to the research protocol.
No significant events or approaches for the overall study following participant enrollment were performed prior to group assignment.
Participant milestones
| Measure |
Gastric Stimactivated Days1-4/Not Activated Days5-8
The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
|
Gastric StimulationNotActivated Days1-4/Activated Days5-8
The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
30
|
|
Overall Study
Completed 1st Intervention
|
22
|
23
|
|
Overall Study
Completed 2nd Intervention
|
22
|
23
|
|
Overall Study
COMPLETED
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Gastric Stimactivated Days1-4/Not Activated Days5-8
The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
|
Gastric StimulationNotActivated Days1-4/Activated Days5-8
The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
|
|---|---|---|
|
Overall Study
Adverse event: lead dislodgement.
|
6
|
7
|
Baseline Characteristics
Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis
Baseline characteristics by cohort
| Measure |
Gastric Stimactivated Days1-4/Not Activated Days5-8
n=28 Participants
The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
|
Gastric StimulationNotActivated Days1-4/Activated Days5-8
n=30 Participants
The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
|
Total
n=58 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
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age Continuous
|
47 years
STANDARD_DEVIATION 13 • n=5 Participants
|
47 years
STANDARD_DEVIATION 14 • n=7 Participants
|
47 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
30 participants
n=7 Participants
|
58 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study Day 0 (Baseline), Day 3, Day 7Likert Scale 0-4 (low-high) using a patient reported outcomes tool
Outcome measures
| Measure |
Gastric Stimactivated Days1-4/Not Activated Days5-8
n=28 Participants
The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
|
Gastric StimulationNotActivated Days1-4/Activated Days5-8
n=30 Participants
The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal electrogastrogram, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
|
|---|---|---|
|
Symptom of Vomiting Associated With Gastroparesis
Vomiting Score Day 0
|
1.82 Patient Self-reported Symptom Score
Standard Error 1.55
|
2.68 Patient Self-reported Symptom Score
Standard Error 1.61
|
|
Symptom of Vomiting Associated With Gastroparesis
Vomiting Score Day 3
|
0.17 Patient Self-reported Symptom Score
Standard Error 0.67
|
1.20 Patient Self-reported Symptom Score
Standard Error 1.47
|
|
Symptom of Vomiting Associated With Gastroparesis
Vomiting Score Day 7
|
0.91 Patient Self-reported Symptom Score
Standard Error 1.44
|
0.72 Patient Self-reported Symptom Score
Standard Error 1.17
|
PRIMARY outcome
Timeframe: Study Day 0 (Baseline), Day 3, Day 7Likert Scale 0-4 (low-high) using a patient reported outcomes tool
Outcome measures
| Measure |
Gastric Stimactivated Days1-4/Not Activated Days5-8
n=28 Participants
The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
|
Gastric StimulationNotActivated Days1-4/Activated Days5-8
n=30 Participants
The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal electrogastrogram, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
|
|---|---|---|
|
Symptom of Nausea Associated With Gastroparesis
Nausea Score Day 3
|
1.46 Patient Self-reported Symptom Score
Standard Error 1.29
|
1.67 Patient Self-reported Symptom Score
Standard Error 1.49
|
|
Symptom of Nausea Associated With Gastroparesis
Nause Score Day 0
|
3.27 Patient Self-reported Symptom Score
Standard Error 0.92
|
3.33 Patient Self-reported Symptom Score
Standard Error 1.03
|
|
Symptom of Nausea Associated With Gastroparesis
Nausea Score Day 7
|
2.26 Patient Self-reported Symptom Score
Standard Error 1.18
|
1.4 Patient Self-reported Symptom Score
Standard Error 1.38
|
PRIMARY outcome
Timeframe: Study Day 0 (Baseline), Day 4, Day 8Transit time of a radio-labeled meal through the stomach, measured by scintigraphy for %contents remaining in the stomach at 1 hour, 2 hours, and 4 hours. GET measures were obtained at baseline, during the period allowed for 'washout', and on the final study day.
Outcome measures
| Measure |
Gastric Stimactivated Days1-4/Not Activated Days5-8
n=28 Participants
The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
|
Gastric StimulationNotActivated Days1-4/Activated Days5-8
n=30 Participants
The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal electrogastrogram, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
|
|---|---|---|
|
Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis
GET Day 4, at 4th hour
|
24.11 percentage of radiolabeled meal in stoma
Standard Error 23.76
|
21.85 percentage of radiolabeled meal in stoma
Standard Error 28.51
|
|
Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis
GET Day 8, at 1st hour
|
64.71 percentage of radiolabeled meal in stoma
Standard Error 21.10
|
68.67 percentage of radiolabeled meal in stoma
Standard Error 19.92
|
|
Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis
GET Day 8, at 2nd hour
|
42.19 percentage of radiolabeled meal in stoma
Standard Error 24.37
|
40.92 percentage of radiolabeled meal in stoma
Standard Error 26.50
|
|
Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis
GET Day 8, at 4th hour
|
24.71 percentage of radiolabeled meal in stoma
Standard Error 27.94
|
20.25 percentage of radiolabeled meal in stoma
Standard Error 25.26
|
|
Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis
GET Day 0, at 1st hour
|
67.07 percentage of radiolabeled meal in stoma
Standard Error 20.23
|
66.13 percentage of radiolabeled meal in stoma
Standard Error 25.37
|
|
Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis
GET Day 0, at 2nd hour
|
69.96 percentage of radiolabeled meal in stoma
Standard Error 23.79
|
37.41 percentage of radiolabeled meal in stoma
Standard Error 28.06
|
|
Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis
GET Day 0, at 4th hour
|
64.71 percentage of radiolabeled meal in stoma
Standard Error 21.10
|
16.43 percentage of radiolabeled meal in stoma
Standard Error 23.00
|
|
Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis
GET Day 4, at 1st hour
|
69.96 percentage of radiolabeled meal in stoma
Standard Error 23.79
|
62.35 percentage of radiolabeled meal in stoma
Standard Error 24.75
|
|
Symptom of Gastric Emptying Time (GET) Associated With Gastroparesis
GET Day 4, at 2nd hour
|
46.85 percentage of radiolabeled meal in stoma
Standard Error 25.30
|
38.00 percentage of radiolabeled meal in stoma
Standard Error 24.64
|
Adverse Events
Gastric Stimactivated
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Gastric StimulationNotActivated
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gastric Stimactivated
n=51 participants at risk
Gastric Electrical Stimulation
|
Gastric StimulationNotActivated
n=52 participants at risk
Sham stimulation
|
|---|---|---|
|
Gastrointestinal disorders
Lead Dislodgment
|
11.8%
6/51 • Number of events 6 • Study Days 0-8 (Entirety of Study)
|
13.5%
7/52 • Number of events 7 • Study Days 0-8 (Entirety of Study)
|
Additional Information
Thomas L. Abell, MD, Professor of Medicine
University of Mississippi Medical Center
Phone: 6019844540
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place