Phase 2 Study of pH Gastrilex™ (Enteric-Coated Amorphous Calcium Carbonate Capsules) in Moderate-to-Severe Crohn's Disease
NCT07928700, Phase 2, Completed, Soroka University Medical Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Phase 2 Study of pH Gastrilex™ (Enteric-Coated Amorphous Calcium Carbonate Capsules) in Moderate-to-Severe Crohn's Disease | ClinicalTrials.gov |
| NCT number | NCT07928700 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 23 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Soroka University Medical Center | ClinicalTrials.gov |
| Conditions | Inflammatory Bowel Disease, Crohn Disease | ClinicalTrials.gov |
| Interventions | PH Gastrilex, Placebo Comparator | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change From Baseline in Crohn's Disease Activity Index (CDAI) | Baseline and 12 weeks | Change in CDAI score from baseline to Week 12. The Crohn's Disease Activity Index (CDAI) is a composite score assessing Crohn's disease activity based on clinical and patient-reported parameters | ClinicalTrials.gov |
| Primary | Change From Baseline in Crohn's Disease Activity Index (CDAI) | Baseline and 24 weeks | Change in CDAI score from baseline to Week 24. The Crohn's Disease Activity Index (CDAI) is a composite score assessing Crohn's disease activity based on clinical and patient-reported parameters | ClinicalTrials.gov |
| Secondary | Percentage of participants achieving clinical remission Clinical Remission | Baseline, Week 12, Week 24, and Week 72 | The percentage of participants achieving clinical remission, defined as Crohn's Disease Activity Index (CDAI) ≤150. | ClinicalTrials.gov |
| Secondary | Percentage of participants achieving clinical response | Baseline, Week 12, Week 24, and Week 72 | The percentage of participants with a reduction in CDAI of at least 100 points from baseline. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Stool Frequency | Baseline, Week 12, Week 24, and Week 72 | Change from baseline in the mean daily number of liquid or very soft stools, as assessed by the CDAI over a 7-day period | ClinicalTrials.gov |
| Secondary | Change From Baseline in Abdominal Pain Score | Baseline, Week 12, Week 24, and Week 72 | Change in the CDAI abdominal pain component, assessed daily on a 4-point scale (0 = none; 1 = mild; 2 = moderate; 3 = severe). | ClinicalTrials.gov |
| Secondary | Endoscopic Response | Baseline, Week 24, and Week 72 | Achieving a ≥50% reduction from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD). | ClinicalTrials.gov |
| Secondary | Change From Baseline in Quality of Life (SIBDQ) | Baseline, Week 12, Week 24, and Week 72 | Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score (range 10-70; higher scores indicate better quality of life). | ClinicalTrials.gov |
| Secondary | Long-Term Maintenance of Clinical Remission | Week 24 through Week 72 | Percentage of participants maintaining clinical remission (CDAI≤150) during the open-label extension. | ClinicalTrials.gov |
| Secondary | Long-Term Maintenance of Clinical Response | Week 24 through Week 72 | Percentage of participants maintaining clinical response, defined as a reduction in CDAI score of at least 100 points from baseline, during the open-label extension. | ClinicalTrials.gov |
| Secondary | C-Reactive Protein (CRP) Normalization | Baseline, Week 12, Week 24, and Week 72 | Percentage of participants achieving CRP levels ≤0.5 mg/dL. | ClinicalTrials.gov |
| Secondary | Fecal Calprotectin ≤250 µg/g | Baseline, Week 12, Week 24, and Week 72 | Percentage of participants achieving fecal calprotectin levels ≤250 µg/g. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
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 | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)