A Phase 4 interventional study of Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation. and Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation. in IBD (Inflammatory Bowel Disease), sponsored by Humanitas Clinical and Research Center. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by Humanitas Clinical and Research Center · Phase 4, Interventional, and Treatment
Among 93 studies in Inflammatory Bowel Diseases with a site in Italy — 34 open to participants now, 43 under way, 5 of them phase 3. Inflammatory Bowel Diseases · Italy.
Among the 93 studies in Inflammatory Bowel Diseases with a site in Italy, this one is the 19th largest by planned enrollment of the 56 interventional ones that give a count, is one of 8 that started in 2025, is one of 7 in phase 4, reaches primary completion later than 12 of the 42 other live ones, and was the 80th registered.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 425 are open to participants now.
Browse Inflammatory Bowel Diseases studies →34 of the 93 studies in Inflammatory Bowel Diseases with a site in Italy are open now. Recruiting first, the newest first:
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Sites in Italy
Ages 2–17 · Healthy volunteers
Palisade Bio · Sites in Italy, United States, Canada and 9 more countries
Ages 18–75
Eli Lilly and Company · Sites in Italy, United States, Canada and 4 more countries
Ages 3 wk+ · Women only
Multidisciplinary Italian Study group for STOmas (MISSTO) · Sites in Italy
Ages 18+
Spyre Therapeutics, Inc. · Sites in Italy, United States, Argentina and 32 more countries
Ages 18–75
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 277 Inflammatory Bowel Diseases studies recruiting now, 133 (48%) set no upper age limit and 117 (42%) stop at 75 or younger; 76 take children under 18; 61 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
93 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 20 · Phase 3 17 · Phase 4 7
First in 2005; this study’s year is marked. 8 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above the median of 68 across 870 interventional studies indexed under Inflammatory Bowel Diseases.
Median enrollment 150 across the 56 interventional studies, 200 across the 37 observational. Of the 43 that completed or were terminated, 18 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
39 of 93 have an industry lead sponsor. The 10 most frequent:
Humanitas Clinical and Research Center is the lead sponsor of 33 studies on the registry; 6 are open to participants now.
Humanitas Clinical and Research Center has 1 study filed under Inflammatory Bowel Diseases — fewer than ten, so there is no comparison to draw.
9 of the studies in Inflammatory Bowel Diseases with a site in Italy that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05923073Phase 3Janssen Research & Development, LLCA Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease | 2027-10-27 |
| NCT07670988Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaEpidemiological Evaluation Of Chronic Kidney Disease In Pediatric Patients With Inflammatory Bowel Disease | 2026-11 |
| NCT06793124IRCCS Azienda Ospedaliero-Universitaria di BolognaComparison Diagnostic Tests for the Diagnosis of CYTOmegalovirus Organ Disease in Patients With intestinalBOweL Diseases | 2026-12-31 |
| NCT07670975Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaResting Energy Expenditure in Pediatric Patients With Inflammatory Bowel Disease (REE-MICI) | 2027-03 |
| NCT06896305IRCCS Ospedale San RaffaeleImpact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Randomized, Double-arm, Open-label Study | 2027-04-01 |
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Among the 93 studies in Inflammatory Bowel Diseases with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to compare two sedation regimens-remimazolam and midazolam-for colonoscopy in adult patients with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis.
The main questions it aims to answer are:
Researchers will compare sedation with remimazolam plus fentanyl to sedation with midazolam plus fentanyl to see if remimazolam improves patient experience and procedural efficiency.
Participants will:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age ≥18 years
IV
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ARM 2: Participants receive intravenous remimazolam plus fentanyl for procedural sedation during colonoscopy
Drug: Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation.
Arm Description: ARM 1: Participants receive intravenous midazolam plus fentanyl for procedural sedation during colonoscopy.
Drug: Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation.
\- Remimazolam + Fentanyl IV fentanyl 100 mcg is given first, followed after 1 minute by IV remimazolam 5 mg over 1 minute. Additional 2.5 mg boluses may be given every 2 minutes as needed. Colonoscopy starts 1 minute after sedation. Vital signs are monitored throughout.
\- Midazolam + Fentanyl (≤1000 caratteri) IV fentanyl 100 mcg is given first, followed after 1 minute by IV midazolam 3 mg over 1 minute. Additional midazolam may be administered based on clinical judgment. Colonoscopy starts 1 minute after sedation. Vital signs are monitored throughout.
Patient satisfaction
Proportion of patients reporting at least "satisfied" with sedation (Likert scale 1-4, 3 or 4 points)
Time frame: Immediately post-procedure
Patient high satisfaction
Proportion reporting "very satisfied" (Likert scale 1-4, 4 points)
Time frame: Immediately post-procedure
Incidence of treatment-emergent adverse events
Proportion of patients experiencing any of the following adverse events (occurring after the administration of the study drug): * Desaturation: peripheral oxygen saturation (SpO₂) below 90% * Tachycardia: heart rate greater than 100 bpm * Bradycardia: heart rate less than 50 bpm * Hypotension: systolic blood pressure below 90 mmHg
Time frame: Throughout the observation period (i.e., until discharge)
Discharge readiness 10'
Proportion of patients ready for discharge (PADSS ≥9)
Time frame: 10 minutes post-procedure
Dischatge readiness 20'
Proportion of patients ready for discharge (PADSS ≥9)
Time frame: 20 minutes post-procedure
Maximum net benefit
Proportion of patients reportinng "very satisfied" with sedation (Likert scale 1-4, 4 points) + ready for discharge (PADSS ≥9)
Time frame: 10 minutes post-procedure
Endoscopy metrics - cecal intubation rate
Percentage of procedures where the endoscope successfully reaches the cecum and can be visually confirmed by inspecting the appendiceal orifice
Time frame: During procedure
Endoscopy metrics - cecal intubation time
Time from the insertion of the colonoscope tip into the anal verge until reaching the cecal base
Time frame: During procedure
Plan to share: Yes — De-identified individual participant data (IPD) related to primary and secondary outcomes may be shared with qualified researchers upon reasonable request and subject to institutional and ethical approval. Data will be available after publication and will include demographic data, sedation details, outcome measures, and adverse events. Access will require a data-sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: IPD will be made available within 6 months after publication of the main results and will remain available for up to 1 year thereafter.
Access criteria: Qualified researchers affiliated with academic institutions, healthcare organizations, or regulatory agencies will be able to request access to the de-identified individual participant data (IPD), including demographic variables, treatment allocation, sedation response, recovery scores, adverse events, and primary/secondary outcomes. Supporting documents such as the study protocol and statistical analysis plan (SAP) will also be available. Access will be granted upon submission and approval of a written data request, which must include a brief research proposal and data use rationale. A data-sharing agreement must be signed prior to access. Data will be shared securely via encrypted files or institutional data-sharing platforms approved by the sponsor institution.
Data sharing details ↗ · www.humanitas-research.com
Start is estimated for Sep 2025; primary completion for Sep 2025, 0 months later.
Of 33 non-industry phase 4 interventional studies under Inflammatory Bowel Diseases, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 63. This study's planned 0 months is below that.
Counting every sponsor, half of 38 studies reached it within 38 months; a quarter within 21 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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