Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194818
Status:
COMPLETED
Last Update Posted:
2008-02-15
First Post:
2005-09-15
Brief Title:
Asacol Dosing Study for Active Ulcerative Colitis
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Open Label Safety and Efficacy Trial of Twice Daily Dosing of Asacol vs Three Times Per Day Dosing for the Induction of Remission in Active Ulcerative Colitis
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We the investigators at University of Washington plan on evaluating the effect of open label Asacol at a dose of 48 gramsday divided BID twice per day or TID three times per day on its ability to induce remission in patients with mild to moderately active ulcerative colitis We hypothesize that both regimens will have the same efficacy and no difference in side effects
Detailed Description:
We plan to perform an open label efficacy and safety pilot study with Asacol a mesalamine product for mild to moderately active ulcerative colitis An investigator to confirm the diagnosis of ulcerative colitis will review the medical records of potentially eligible patients
At least one week prior to enrollment potentially eligible patients will be evaluated to score the Ulcerative colitis clinical activity index UCAI This index incorporates eight items stool frequency blood in stools general well being abdominal pain fever extra-intestinal manifestations sedimentation rate and hemoglobin Scores range from 0-32 A score of more than 4 on this index is considered clinically significant A total score of 4-12 represents mild to moderate activity of colitis A routine clinic visit will be scheduled before entry at which time a standard physical examination stool samples to evaluate for infections and blood tests will be performed Base-line demographic information scores on the UCAI and data on medication use will be obtained at this visit Quality of life will be measured one week prior to randomization with the Inflammatory Bowel Disease Questionnaire a previously validated instrument with four parts on bowel function emotional status systemic symptoms and social function the total score on this index ranges from 32 to 224 with higher scores indicating better quality of life The scores of patients in remission usually range from 170 to 190
One half of those enrolled in the study will be started on Asacol 6 tablets BID 48 gramsday The other half of patients enrolled will be started on Asacol 4 tablets TID 48 gramsday If patients do not tolerate the starting dose they will be titrated down until they reach a tolerable dose During the first 6 weeks of the study all other medications will be held at stable doses Patients will be seen at week 2 for symptom evaluation and undergo a standard physical exam and basic laboratory tests At week 4 the patients will again be evaluated and undergo a standard physical examination and standard blood tests will be performed All patients will be asked to provide a stool sample at visit 1 and their final visit to measure a fecal lactoferrin which provides an objective measure of inflammation in the colon
At week 6 other disease modifying medications may be used or altered accordingly All patients will be seen for week 8 or 2 weeks after being considered a study failure ie if patients drop out at week 2 they would be seen at week 4 for re-evaluation of symptoms At week 12 if patients have failed to show improvement achieve remission or if they have require other medications they will have been considered to fail the study Participants have achieved remission defined as a UCAI of more than 4 or had a response defined as a reduction in CAI score of less than 4 they will be considered to have responded to the medication
The primary outcome measure of the trial will be the presence of clinical improvement by week 12 as defined by decrease in the UCAI score of more than 4 The proportion of patients in each arm who achieve clinical response in arm of the trial will be compared The proportion of patients in each arm who achieve remission to therapy as measured by a reduction in UCAI score of less than 4 will be examined as a secondary outcome measure Other secondary outcomes will include improvement in Inflammatory Bowel Disease Questionnaire IBDQ scores time to clinical response self-reported patient satisfaction patient compliance based on pill count and time to failure The number of patients in each arm requiring the addition of disease modifying medication will be evaluated The primary endpoint will be adjusted for disease modifying agents should there be a significant difference between the groups in use of these medications but the power to do so may be limited based on the sample size of this study
The proportion of patients achieving clinical remission or response in each arm will be compared using Fishers exact test Comparisons of continuous variables such as UCAI scores and IBDQ scores will be performed using the non-parametric Mann-Whitney U test Because the goal of the proposed study is to generate pilot data to support a larger randomized trial the power to detect a clinically important difference between the two dosing regimens will be limited Assuming a 75 rate of clinical remission in the TID group the proposed sample size of 10 patients per group will allow us to detect a 25 decrease in the rate of remission in the BID group
As this is an open label study investigators will have access to all clinical information concerning adverse events and response rates throughout the study We will assess safety and efficacy differences between the two groups after 5 patients have been randomized to each arm Should more than 20 n2 of the patients develop serious adverse events necessitating the discontinuation of Asacol the study will be stopped In addition we will halt the study if there is greater than a 40 difference in efficacy between the treatment groups at the midway point of the trial
At least one week prior to enrollment potentially eligible patients will be evaluated to score the Ulcerative colitis clinical activity index UCAI This index incorporates eight items stool frequency blood in stools general well being abdominal pain fever extra-intestinal manifestations sedimentation rate and hemoglobin Scores range from 0-32 A score of more than 4 on this index is considered clinically significant A total score of 4-12 represents mild to moderate activity of colitis A routine clinic visit will be scheduled before entry at which time a standard physical examination stool samples to evaluate for infections and blood tests will be performed Base-line demographic information scores on the UCAI and data on medication use will be obtained at this visit Quality of life will be measured one week prior to randomization with the Inflammatory Bowel Disease Questionnaire a previously validated instrument with four parts on bowel function emotional status systemic symptoms and social function the total score on this index ranges from 32 to 224 with higher scores indicating better quality of life The scores of patients in remission usually range from 170 to 190
One half of those enrolled in the study will be started on Asacol 6 tablets BID 48 gramsday The other half of patients enrolled will be started on Asacol 4 tablets TID 48 gramsday If patients do not tolerate the starting dose they will be titrated down until they reach a tolerable dose During the first 6 weeks of the study all other medications will be held at stable doses Patients will be seen at week 2 for symptom evaluation and undergo a standard physical exam and basic laboratory tests At week 4 the patients will again be evaluated and undergo a standard physical examination and standard blood tests will be performed All patients will be asked to provide a stool sample at visit 1 and their final visit to measure a fecal lactoferrin which provides an objective measure of inflammation in the colon
At week 6 other disease modifying medications may be used or altered accordingly All patients will be seen for week 8 or 2 weeks after being considered a study failure ie if patients drop out at week 2 they would be seen at week 4 for re-evaluation of symptoms At week 12 if patients have failed to show improvement achieve remission or if they have require other medications they will have been considered to fail the study Participants have achieved remission defined as a UCAI of more than 4 or had a response defined as a reduction in CAI score of less than 4 they will be considered to have responded to the medication
The primary outcome measure of the trial will be the presence of clinical improvement by week 12 as defined by decrease in the UCAI score of more than 4 The proportion of patients in each arm who achieve clinical response in arm of the trial will be compared The proportion of patients in each arm who achieve remission to therapy as measured by a reduction in UCAI score of less than 4 will be examined as a secondary outcome measure Other secondary outcomes will include improvement in Inflammatory Bowel Disease Questionnaire IBDQ scores time to clinical response self-reported patient satisfaction patient compliance based on pill count and time to failure The number of patients in each arm requiring the addition of disease modifying medication will be evaluated The primary endpoint will be adjusted for disease modifying agents should there be a significant difference between the groups in use of these medications but the power to do so may be limited based on the sample size of this study
The proportion of patients achieving clinical remission or response in each arm will be compared using Fishers exact test Comparisons of continuous variables such as UCAI scores and IBDQ scores will be performed using the non-parametric Mann-Whitney U test Because the goal of the proposed study is to generate pilot data to support a larger randomized trial the power to detect a clinically important difference between the two dosing regimens will be limited Assuming a 75 rate of clinical remission in the TID group the proposed sample size of 10 patients per group will allow us to detect a 25 decrease in the rate of remission in the BID group
As this is an open label study investigators will have access to all clinical information concerning adverse events and response rates throughout the study We will assess safety and efficacy differences between the two groups after 5 patients have been randomized to each arm Should more than 20 n2 of the patients develop serious adverse events necessitating the discontinuation of Asacol the study will be stopped In addition we will halt the study if there is greater than a 40 difference in efficacy between the treatment groups at the midway point of the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None