Ignite Creation Date:
2024-05-06 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05055128
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2021-09-14
Brief Title:
A Study in Patients With Erosive Esophagitis to Investigate Safety Tolerability and Healing Rates After 4 Weeks Treatment of X842 or Lansoprazole and Symptom Pattern During Subsequent 4 Weeks Treatment With Lansoprazole
Sponsor:
Cinclus Pharma AG
Organization:
Cinclus Pharma AG
Study Overview
Official Title:
A Randomized Double-blind Double Dummy Active Comparator-controlled Dose-finding Study in Patients With Erosive Esophagitis Due to Gastro-esophageal Reflux Disease GERD Los Angeles Grade C or D and Patients With at Least Partial Symptom Response But Endoscopically Still Unhealed After 8 Weeks History of Standard Treatment Healing Course With Proton-pump Inhibitor PPI to Investigate Safety Tolerability and Healing Rates After 4 Weeks Treatment of X842 or Lansoprazole and Symptom Pattern During Subsequent 4 Weeks Treatment With Lansoprazole
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be conducted in patients with erosive esophagitis due to gastro-esophageal reflux disease GERD Los Angeles LA grades C or D and in patients with at least partial symptom response but still endoscopically unhealed LA grades A or B after 8 weeks history of standard treatment healing course with PPI designed to support dose selection for Phase 3 and to investigate safety tolerability and healing rates after 4 weeks treatment of X842 or Lansoprazole and symptom pattern during subsequent 4 weeks treatment with Lansoprazole
Detailed Description:
This is a randomized double-blind active comparator-controlled study with a parallel-group design including four arms with X842 and one arm with Lansoprazole
Randomization to one of the treatments with X842 twice daily BID 25 mg 50 mg 75 mg 100 mg or Lansoprazole 30 mg once daily QD will be based on a 11111 scheme
The duration of each patients participation in the study including screening blind treatment period and open-label treatment period will be approximately 60 days The patients will be randomized for 4 weeks of double-blind treatment and will be provided with investigational medicinal product for 35 days
All patients will have an endoscopic evaluation after 4 weeks of treatment Following the endoscopic evaluation all patients will receive subsequent 4 weeks of open-label treatment with Lansoprazole Repeated symptom evaluation to detect symptom patterns will be assessed during this period
Randomization to one of the treatments with X842 twice daily BID 25 mg 50 mg 75 mg 100 mg or Lansoprazole 30 mg once daily QD will be based on a 11111 scheme
The duration of each patients participation in the study including screening blind treatment period and open-label treatment period will be approximately 60 days The patients will be randomized for 4 weeks of double-blind treatment and will be provided with investigational medicinal product for 35 days
All patients will have an endoscopic evaluation after 4 weeks of treatment Following the endoscopic evaluation all patients will receive subsequent 4 weeks of open-label treatment with Lansoprazole Repeated symptom evaluation to detect symptom patterns will be assessed during this period
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-003319-91 | EUDRACT_NUMBER | None | None |