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Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®

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ClinicalTrials.gov Identifier: NCT00652834
Recruitment Status : Completed
First Posted : April 4, 2008
Results First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Suphamai Bunnapradist, University of California, Los Angeles

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Gastrointestinal Lesions
Signs and Symptoms, Digestive
Interventions Procedure: Small bowel capsule endoscopy (SBCE)
Drug: myfortic
Enrollment 23
Recruitment Details Kidney Transplant Clinic
Pre-assignment Details  
Arm/Group Title Kidney Transplant Recipients With GI Symptoms
Hide Arm/Group Description

Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.

Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2.

Period Title: Overall Study
Started 23
Completed 18 [1]
Not Completed 5
Reason Not Completed
Withdrawal by Subject             3
Lost to Follow-up             2
[1]
3 subjects withdrew after completing baseline questionnaire. 2 did not complete 30-day visit.
Arm/Group Title Kidney Transplant Recipients With GI Symptoms
Hide Arm/Group Description

If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.

Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.

Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2.

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
of 23 participants, 18 participants completed the study.
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
45  (11.69)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  94.4%
>=65 years
1
   5.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
8
  44.4%
Male
10
  55.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title GI Mucosal Lesions Change and Clinical Symptoms Using The Gastrointestinal Symptom Rating Scale (GSRS) Score
Hide Description

The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.

A higher GSRS indicate worse symptoms and a difference between D30 and last SBCE scores greater or equal to 0.3 can be considered as a clinically significant improvement in the symptoms.

Time Frame one month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Kidney Transplant Recipients With GI Symptoms
Hide Arm/Group Description:

If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.

Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.

Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2.

Overall Number of Participants Analyzed 18
Mean (95% Confidence Interval)
Unit of Measure: GSRS score
baseline
2.99
(2.18 to 3.80)
day 30
2.19
(1.39 to 2.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Kidney Transplant Recipients With GI Symptoms
Comments

The results of the initial SBCE exams were evaluated by a visually challenged GI specialist who gave us a descriptive report. By the end of the study, we submitted the final reports to the same specialist and asked his impression on the significant changes observed in patients' exams for each GI segment (stomach and small bowel).

There were no comparison groups. Each patient is their own control. Given that this is a pilot study there is no power calculation.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments The p value is only for GSRS score comparison only.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0
Estimation Comments The GSRS range is 1-7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Kidney Transplant Recipients With GI Symptoms
Hide Arm/Group Description

If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.

Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.

Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2.

All-Cause Mortality
Kidney Transplant Recipients With GI Symptoms
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Kidney Transplant Recipients With GI Symptoms
Affected / at Risk (%)
Total   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Kidney Transplant Recipients With GI Symptoms
Affected / at Risk (%)
Total   0/23 (0.00%) 
We did not enroll asymptomatic patients and in the extension of the trial the number of patients re-examined were few and the data obtained from them are not enough to provide definitive information.
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: Dr. Bunnapradist
Organization: UCLA Kidney Transplant Research Program
Phone: 310-794-8516
EMail: bunnapradist@mednet.ucla.edu
Other Publications:
Layout table for additonal information
Responsible Party: Suphamai Bunnapradist, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00652834     History of Changes
Other Study ID Numbers: 11-001911
First Submitted: April 1, 2008
First Posted: April 4, 2008
Results First Submitted: December 2, 2014
Results First Posted: March 4, 2016
Last Update Posted: March 4, 2016