Clinical trial • Phase III • Other
DF2755A for Interstitial cystitis / bladder pain syndrome
Phase III trial of DF2755A for Interstitial cystitis / bladder pain syndrome. None/Not specified-controlled, adaptive. 56 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Interstitial cystitis / bladder pain syndrome
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 15-09-2025
- First CTIS Authorization Date
- 17-10-2025
Trial design
None/Not specified-controlled, adaptive Phase III trial across 1 site in Netherlands.
- Comparator
- None/Not specified
- Adaptive
- True - Dose-escalation (single-ascending and multiple-ascending dose) and food effect; no specific dose escalation rules, interim analyses or stopping rules provided in the available record.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 56
Eligibility
Recruits 56 Vulnerable population selected: true; no further details on consent or assent handling available..
- Vulnerable Population
- Vulnerable population selected: true; no further details on consent or assent handling available.
Recruitment
- Planned Sample Size
- 56
- Recruitment Window Months
- 9
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 56
Netherlands
- Earliest CTIS Part Ii Submission Date
- 13-10-2025
- Latest Decision Or Authorization Date
- 17-10-2025
- Processing Time Days
- 4
- Number Of Sites
- 1
- Number Of Participants
- 56
Sites
- Site Name
- Pharmaceutical Research Associates Group B.V.
- Department Name
- Program Management
- Contact Person Name
- Maria Velinova
- Contact Person Email
- maria.velinova@iconplc.com
- Number Of Participants
- 56
Sponsor
Primary sponsor
- Full Name
- Dompe' Farmaceutici S.p.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Italy
Investigational products
- Investigational Product Name
- DF2755A
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