Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383273
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-04-17
Brief Title:
A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement CELR
Sponsor:
Melt Pharmaceuticals
Organization:
Melt Pharmaceuticals
Study Overview
Official Title:
A Phase 3 Randomized Double-Masked Placebo-Controlled Parallel-Group Multi-Center Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement CELR
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The goal of this clinical trial is to learn if MELT-300 works on procedural sedation in adult participants undergoing cataract extraction with lens replacement CELR It will also learn about the safety of MELT-300 Researchers will compare MELT-300 to a placebo a look-alike substance that contains no drug to see if MELT-300 works on procedural sedation in adult participants undergoing CELR Researchers will also include a comparator SL midazolam to confirm the benefit of inclusion of ketamine in the combined drug product
The main questions it aims to answer are
1 Does MELT-300 is effective in comparison to placebo on procedural sedation for cataract surgery
2 To determine the effectiveness of MELT-300 compared with midazolam on procedural sedation to determine the contribution of ketamine component and inform the risk of ketamine in MELT-300
3 To determine the time to achieve preoperative target sedation level with MELT-300
4 What medical problems do participants have when taking MELT-300 vs placebo
Eligible participants will admitted to the study unit on Day 1 Participants will be randomized prior to surgery 411 to
1 MELT-300 ie 1 MELT-300 sublingual tablet which contains 3 mg midazolam and 50 mg of ketamine
2 Midazolam ie 1 matching midazolam sublingual tablet which contains 3 mg midazolam
3 Placebo ie 1 matching placebo sublingual tablet
Participants will receive study medication 30 5 minutes without food or water before planned surgery start defined as instillation of topical ocular anesthetic gel ie 3 drops of chloroprocaine hydrochloride ophthalmic gel
The effectiveness of MELT-300 will be performed after study medication is administered before surgery in the course of surgery and postoperative on Day 1 end of surgery defined as just prior to drape removal The safety of MELT-300 will be performed at baseline in the course of surgery postoperatively on Day 1 and on Day 3 1 day post dose of study medication
The main questions it aims to answer are
1 Does MELT-300 is effective in comparison to placebo on procedural sedation for cataract surgery
2 To determine the effectiveness of MELT-300 compared with midazolam on procedural sedation to determine the contribution of ketamine component and inform the risk of ketamine in MELT-300
3 To determine the time to achieve preoperative target sedation level with MELT-300
4 What medical problems do participants have when taking MELT-300 vs placebo
Eligible participants will admitted to the study unit on Day 1 Participants will be randomized prior to surgery 411 to
1 MELT-300 ie 1 MELT-300 sublingual tablet which contains 3 mg midazolam and 50 mg of ketamine
2 Midazolam ie 1 matching midazolam sublingual tablet which contains 3 mg midazolam
3 Placebo ie 1 matching placebo sublingual tablet
Participants will receive study medication 30 5 minutes without food or water before planned surgery start defined as instillation of topical ocular anesthetic gel ie 3 drops of chloroprocaine hydrochloride ophthalmic gel
The effectiveness of MELT-300 will be performed after study medication is administered before surgery in the course of surgery and postoperative on Day 1 end of surgery defined as just prior to drape removal The safety of MELT-300 will be performed at baseline in the course of surgery postoperatively on Day 1 and on Day 3 1 day post dose of study medication
Detailed Description:
This is a Phase 3 randomized double-masked placebo-controlled parallel-cohort multicenter study to evaluate the efficacy and safety of MELT-300 compared with placebo on procedural sedation in adult participants undergoing CELR An active comparator SL midazolam is also included in the trial in part to confirm the benefit of inclusion of ketamine in the combined drug product
Approximately 528 participants will be enrolled in 3 parallel treatment arms to assess efficacy endpoints
Eligible participants will be admitted to the study unit on Day 1 Participants will be randomized prior to surgery 411 to
1 MELT-300 ie 1 MELT-300 sublingual tablet which contains 3 mg midazolam and 50 mg of ketamine
2 Midazolam ie 1 matching midazolam sublingual tablet which contains 3 mg midazolam
3 Placebo ie 1 matching placebo sublingual tablet Participants will receive study medication 30 5 minutes without food or water before planned surgery start defined as instillation of topical ocular anesthetic gel ie 3 drops of chloroprocaine hydrochloride ophthalmic gel
Efficacy assessments will be performed after study medication administration before surgery intraoperatively and postoperative on Day 1 end of surgery defined as just prior to drape removal Efficacy assessments will include assessments of sedation need for rescue medication for sedation need for rescue medication for pain and the ability to complete the surgery
Safety will be monitored at baseline intraoperatively postoperatively on Day 1 and on Day 3 1 day post dose of study medication Safety assessment will include monitoring of AEs vital sign measurements and physical examinations
Approximately 528 participants will be enrolled in 3 parallel treatment arms to assess efficacy endpoints
Eligible participants will be admitted to the study unit on Day 1 Participants will be randomized prior to surgery 411 to
1 MELT-300 ie 1 MELT-300 sublingual tablet which contains 3 mg midazolam and 50 mg of ketamine
2 Midazolam ie 1 matching midazolam sublingual tablet which contains 3 mg midazolam
3 Placebo ie 1 matching placebo sublingual tablet Participants will receive study medication 30 5 minutes without food or water before planned surgery start defined as instillation of topical ocular anesthetic gel ie 3 drops of chloroprocaine hydrochloride ophthalmic gel
Efficacy assessments will be performed after study medication administration before surgery intraoperatively and postoperative on Day 1 end of surgery defined as just prior to drape removal Efficacy assessments will include assessments of sedation need for rescue medication for sedation need for rescue medication for pain and the ability to complete the surgery
Safety will be monitored at baseline intraoperatively postoperatively on Day 1 and on Day 3 1 day post dose of study medication Safety assessment will include monitoring of AEs vital sign measurements and physical examinations
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?:
False
Is an FDA AA801 Violation?:
None