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Trial Outcomes & Findings for Placebo Controlled Trial of Botulinum Toxin for Gastroparesis (NCT NCT00372970)

NCT ID: NCT00372970

Last Updated: 2015-06-09

Results Overview

Scale for GI symptoms related to gastroparesis. For this we will use the gastroparesis cardinal symptom index (GCSI). The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). Scores range from 0-5 for the nine items and an asymptomatic patient would have a score of 0 with a highly symptomatic patient having a score of 45. For this study the score had to be \>=27. In a previous study internal consistency reliability was 0.84 for the GCSI total score and ranged from 0.83 to 0.85 for the subscale scores. Two week test retest reliability was 0.76 for the total score and ranged from 0.68 to 0.81 for subscale scores.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

1 month

Results posted on

2015-06-09

Participant Flow

Patients all recruited at Temple University Hospital from 7/1/2005 to 9/1/2007

Participant milestones

Participant milestones
Measure
Botulinum Toxin
Received 200U of Botox injected into pyloric sphincter endoscopically.
Placebo
Received 5 cc saline injected into pyloric sphincter endoscopically.
Overall Study
STARTED
16
16
Overall Study
COMPLETED
16
16
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Placebo Controlled Trial of Botulinum Toxin for Gastroparesis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Botulinum Toxin
n=16 Participants
Received 200U of Botox injected into pyloric sphincter endoscopically.
Placebo
n=16 Participants
Received 5 cc saline injected into pyloric sphincter endoscopically.
Total
n=32 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
16 Participants
n=5 Participants
16 Participants
n=7 Participants
32 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
41.6 years
STANDARD_DEVIATION 11.6 • n=5 Participants
40.4 years
STANDARD_DEVIATION 13.0 • n=7 Participants
41.1 years
STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male
Female
13 Participants
n=5 Participants
13 Participants
n=7 Participants
26 Participants
n=5 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
3 Participants
n=7 Participants
6 Participants
n=5 Participants
Region of Enrollment
United States
16 participants
n=5 Participants
16 participants
n=7 Participants
32 participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: All patients had gastroparesis and underwent EGD. Injection double blinded.

Scale for GI symptoms related to gastroparesis. For this we will use the gastroparesis cardinal symptom index (GCSI). The GCSI is based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). Scores range from 0-5 for the nine items and an asymptomatic patient would have a score of 0 with a highly symptomatic patient having a score of 45. For this study the score had to be \>=27. In a previous study internal consistency reliability was 0.84 for the GCSI total score and ranged from 0.83 to 0.85 for the subscale scores. Two week test retest reliability was 0.76 for the total score and ranged from 0.68 to 0.81 for subscale scores.

Outcome measures

Outcome measures
Measure
Botox
n=16 Participants
Botox injection into pylorus
Placebo
n=16 Participants
saline Injection into pylorus
Symptom Response as Assessed by the Gastroparesis Cardinal Symptom Index.
6.8 units on a scale
Standard Deviation 9.2
10.1 units on a scale
Standard Deviation 12.7

Adverse Events

Botox

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Botox
n=16 participants at risk
Botox injection into pylorus
Placebo
n=16 participants at risk
saline Injection into pylorus
Nervous system disorders
Headache
37.5%
6/16 • Number of events 6
18.8%
3/16 • Number of events 3
Nervous system disorders
Fatigue
18.8%
3/16 • Number of events 3
18.8%
3/16 • Number of events 3
General disorders
Other
0.00%
0/16
0.00%
0/16
General disorders
other
0.00%
0/16
0.00%
0/16

Additional Information

Frank Friedenberg

Temple University

Phone: 215-707-9900

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place