Trial · NCT04768010
Misoprostol for Bloating and Distension
NCT04768010, Early phase 1, Withdrawn, Montefiore Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Misoprostol for Bloating and Distension. Trials, record NCT04768010. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04768010
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Misoprostol for Bloating and Distension
- NCT number
- NCT04768010
- Status
- Withdrawn
- Phases
- Early phase 1
- Enrollment
- 0 participants, actual
- Lead sponsor
- Montefiore Medical Center
- Conditions
- Distension, Gas Bloat Syndrome, Constipation
- Interventions
- Misoprostol
- First posted
- 2021-02-24
- Last updated
- 2023-09-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Patient Assessment of Gastrointestinal Symptoms (PAGI-SYM) Questionnaire Score | Baseline, Day 2, and Day 3 | The PAGI-SYM is a validated 20 item self-report questionnaire divided in to six domains: heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain. Scores for each question range from 0 (none absent) to 5 (very severe). This questionnaire obtains subscale scores derived from the average scores across these six domains. The original questionnaires asks "How severe have each of these following symptoms been in the past two weeks?" For the purpose of this study, we have obtained manufacturer approval to modify the questionnaire to ask about symptoms severity in the past day. |
| Primary | Change in Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire Score | Baseline, Day 1, Day 2, and Day 3 | The PAC-SYM is a validated 12 item self-report questionnaire divided into abdominal, rectal, and stool domains. The questionnaire has 4 items for abdominal symptoms, 3 items for rectal symptoms, and 5 items for stool symptoms. Scores range from 0 (none or absent) to 4 (very severe). The total score is the mean of the individual item scores.The original questionnaires asks "How severe have each of these following symptoms been in the past two weeks?" For the purpose of this study, we have obtained manufacturer approval to modify the questionnaire to ask about symptoms severity in the past day. |
| Secondary | Change in intestinal gas volume from baseline to post-intervention | Baseline and Day 3 | Measured by low dose abdominal CT |
| Secondary | Change in stool burden from baseline to post-intervention | Baseline and Day 3 | Scored using abdominal X-ray |
| Secondary | Change in Abdominal Girth | Baseline, Day 1, Day 2, and Day 3 | Abdominal girth will be measured in centimeters using a tape measure. |
| Secondary | Change in Psychometric Hepatic Encephalopathy Score (PHES) | Baseline, Day 2, and Day 3 | The PHES is a series of five neuropsychological tests used in the diagnosis of minimal hepatic encephalopathy. The tests used in this score include the digit-symbol test, number connection tests A and B, the serial dotting test, and the line-drawing test. The final score for the PHES is derived from the sum of the scores of these individual tests. To determine individual test scores, the difference between the predicted and observed results for each test are divided by the corresponding standard deviation (SD) for the reference population to obtain the deviation from 'normal' as a multiple of the SD. Final scores range from -15 to +5. Lower scores are found in patients with encephalopathy, with a score \<-4 SD being considered to represent the presence of minimal hepatic encephalopathy. |
| Secondary | Change in Abdominal Pain | Baseline, Day 2, and Day 3 | The severity of abdominal pain will de determined from the individual Likert score derived from the Patient Assessment of Gastrointestinal Symptoms (PAGI-SYM). The Likert scale ranges from Scores for each question range from 0 (none absent) to 5 (very severe). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Symbol Coding | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04768010
GET https://conductscience.org/api/trials/v1/NCT04768010/registered