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Placebo Controlled Trial of Botulinum Toxin for Gastroparesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00372970
Recruitment Status : Completed
First Posted : September 7, 2006
Results First Posted : June 9, 2015
Last Update Posted : June 9, 2015
Sponsor:
Collaborator:
American College of Gastroenterology
Information provided by (Responsible Party):
Frank K. Friedenberg, Temple University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Gastroparesis
Interventions Drug: Botulinum toxin A
Drug: Placebo
Enrollment 32
Recruitment Details Patients all recruited at Temple University Hospital from 7/1/2005 to 9/1/2007
Pre-assignment Details  
Arm/Group Title Botulinum Toxin Placebo
Hide Arm/Group Description Received 200U of Botox injected into pyloric sphincter endoscopically. Received 5 cc saline injected into pyloric sphincter endoscopically.
Period Title: Overall Study
Started 16 16
Completed 16 16
Not Completed 0 0
Arm/Group Title Botulinum Toxin Placebo Total
Hide Arm/Group Description Received 200U of Botox injected into pyloric sphincter endoscopically. Received 5 cc saline injected into pyloric sphincter endoscopically. Total of all reporting groups
Overall Number of Baseline Participants 16 16 32
Hide Baseline Analysis Population Description
All patients with documented gastroparesis
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
16
 100.0%
32
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 16 participants 32 participants
41.6  (11.6) 40.4  (13.0) 41.1  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Female
13
  81.3%
13
  81.3%
26
  81.3%
Male
3
  18.8%
3
  18.8%
6
  18.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 16 participants 32 participants
16 16 32
1.Primary Outcome
Title Symptom Response as Assessed by the Gastroparesis Cardinal Symptom Index.
Hide Description

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.

Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
All patients had gastroparesis and underwent EGD. Injection double blinded.
Arm/Group Title Botox Placebo
Hide Arm/Group Description:
Botox injection into pylorus
saline Injection into pylorus
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.8  (9.2) 10.1  (12.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Botox Placebo
Hide Arm/Group Description Botox injection into pylorus saline Injection into pylorus
All-Cause Mortality
Botox Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Botox Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/16 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Botox Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/16 (37.50%)      3/16 (18.75%)    
General disorders     
Other  1 [1]  0/16 (0.00%)  0 0/16 (0.00%)  0
other  2 [2]  0/16 (0.00%)  0 0/16 (0.00%)  0
Nervous system disorders     
Headache *  6/16 (37.50%)  6 3/16 (18.75%)  3
Fatigue *  3/16 (18.75%)  3 3/16 (18.75%)  3
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Non-serious adverse
2
Term from vocabulary, other
[1]
Not serious adverse event
[2]
other non-serious events
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Frank Friedenberg
Organization: Temple University
Phone: 215-707-9900
EMail: frank.friedenberg@temple.edu
Layout table for additonal information
Responsible Party: Frank K. Friedenberg, Temple University
ClinicalTrials.gov Identifier: NCT00372970    
Other Study ID Numbers: 4204
First Submitted: September 5, 2006
First Posted: September 7, 2006
Results First Submitted: April 16, 2015
Results First Posted: June 9, 2015
Last Update Posted: June 9, 2015