Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04768010
Status:
WITHDRAWN
Last Update Posted:
2023-09-28
First Post:
2021-02-19
Brief Title:
Misoprostol for Bloating and Distension
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Misoprostol for the Management of Bloating and Gaseous Distension in Patients With Cirrhosis an Open Label Trial
Status:
WITHDRAWN
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
After significant delays study was never initiated No participants enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Symptoms of bloating abdominal distension and constipation are common in patients with cirrhosis These symptoms may be explained by disease-associated effects in gastrointestinal physiology as well as medication side-effects The presence of these symptoms affect quality of life as well as risk for encephalopathy Misoprostol is a synthetic prostaglandin approved for the treatment prevention of NSAID-induced gastric ulcers The drug also causes smooth muscle contraction in the gastrointestinal tract has been shown to improve colonic motility
This study aims to assess the efficacy of misoprostol for treating bloating distension and constipation in patients with cirrhosis Study participants will receive misoprostol for a duration of three days Participants will complete pre-intervention and post-intervention symptom questionnaires and low dose abdominal computed tomography CT scan These measures will be used to assess subjective symptom scores and objective measurement of intestinal gas and colonic stool Post-intervention measures will be compared to pre-intervention measures to assess improvement of symptoms
This study aims to assess the efficacy of misoprostol for treating bloating distension and constipation in patients with cirrhosis Study participants will receive misoprostol for a duration of three days Participants will complete pre-intervention and post-intervention symptom questionnaires and low dose abdominal computed tomography CT scan These measures will be used to assess subjective symptom scores and objective measurement of intestinal gas and colonic stool Post-intervention measures will be compared to pre-intervention measures to assess improvement of symptoms
Detailed Description:
Specific Aims of Study
To determine whether misoprostol is beneficial in patients with cirrhosis with bloating secondary to stool and gaseous distension patient with marked symptoms that are refractory to standard of care will receive open label Misoprostol 100mcg twice daily and increased to 200mcg twice daily based on response before and after 2 days of treatment with the following assessments
1 Characterization of bloating and abdominal discomfort symptoms as assessed by the Patient Assessment of Constipation PAC-SYM and Patient Assessment of Gastrointestinal Symptoms PAGI-SYM Questionnaires composite scores and subscale scores before
2 Radiologic quantitation of intestinal gaseous distension as assessed by volumetric measurement of ultra-low radiation abdominal CT scan
3 Impact on severity of hepatic encephalopathy scores as assessed by West Haven criteria grading and Psychometric Hepatic Encephalopathy Score PHES
This study is a prospective open-label trial comparing the efficacy of misoprostol in the management of bloating and gaseous distension in patients with cirrhosis
The duration of the study will be over 3 days for each enrolled patient and will include an initial screening encounter prior to day 1 of the study period During the screening encounter participants will receive a complete history and physical including review of treatment with standard of care treatments such as polyethylene glycol bisacodyl docusate senna and simethicone If symptoms are not relieved by the use of these standard of care treatments participants will be fully screened provided informed consent enrolled in the trial
Participants will be administered the PAC-SYM PAGI-SYM questionnaires in addition to determination of West Haven Criteria Grade and PHES These baseline demographics will be collected and used as reference for comparison of post-intervention questionnaire results Baseline abdominal girth will also be documented Afterwards participants will receive a baseline low-dose abdominal CT for the volumetric assessment of intestinal gas Abdominal X-ray available from CT data will be used for scoring of colonic stool burden
Participants will be started on the study medication on day 1 On day 1 participants will receive an initial dose of 100 micrograms of misoprostol administered orally The patient will be monitored for adverse effects and if none observed will continue 100 microgram dose twice daily with increase to 200mcg on day 2 if symptoms not improved All primary outcomes will be assessed daily between morning and evening doses
On the morning of day 3 participants will receive one dose of study drug at dose received on day 2 After administration of the drug participants will repeat ultra-low dose abdominal CT and complete a final assessment with the PAC-SYM PAGI-SYM PHES and West Haven Grading
To determine whether misoprostol is beneficial in patients with cirrhosis with bloating secondary to stool and gaseous distension patient with marked symptoms that are refractory to standard of care will receive open label Misoprostol 100mcg twice daily and increased to 200mcg twice daily based on response before and after 2 days of treatment with the following assessments
1 Characterization of bloating and abdominal discomfort symptoms as assessed by the Patient Assessment of Constipation PAC-SYM and Patient Assessment of Gastrointestinal Symptoms PAGI-SYM Questionnaires composite scores and subscale scores before
2 Radiologic quantitation of intestinal gaseous distension as assessed by volumetric measurement of ultra-low radiation abdominal CT scan
3 Impact on severity of hepatic encephalopathy scores as assessed by West Haven criteria grading and Psychometric Hepatic Encephalopathy Score PHES
This study is a prospective open-label trial comparing the efficacy of misoprostol in the management of bloating and gaseous distension in patients with cirrhosis
The duration of the study will be over 3 days for each enrolled patient and will include an initial screening encounter prior to day 1 of the study period During the screening encounter participants will receive a complete history and physical including review of treatment with standard of care treatments such as polyethylene glycol bisacodyl docusate senna and simethicone If symptoms are not relieved by the use of these standard of care treatments participants will be fully screened provided informed consent enrolled in the trial
Participants will be administered the PAC-SYM PAGI-SYM questionnaires in addition to determination of West Haven Criteria Grade and PHES These baseline demographics will be collected and used as reference for comparison of post-intervention questionnaire results Baseline abdominal girth will also be documented Afterwards participants will receive a baseline low-dose abdominal CT for the volumetric assessment of intestinal gas Abdominal X-ray available from CT data will be used for scoring of colonic stool burden
Participants will be started on the study medication on day 1 On day 1 participants will receive an initial dose of 100 micrograms of misoprostol administered orally The patient will be monitored for adverse effects and if none observed will continue 100 microgram dose twice daily with increase to 200mcg on day 2 if symptoms not improved All primary outcomes will be assessed daily between morning and evening doses
On the morning of day 3 participants will receive one dose of study drug at dose received on day 2 After administration of the drug participants will repeat ultra-low dose abdominal CT and complete a final assessment with the PAC-SYM PAGI-SYM PHES and West Haven Grading
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None