Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy

Pain Clinical Trial

Official title:

Multi-Center, Randomized, Double-Blind, Placebo (Double-Dummy) and Active-Controlled, Parallel-Group Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06215859
• Other study ID #: MR-107A-02-TFZ-3002
• Status: Recruiting
• Phase: Phase 3
• Start date: December 29, 2023
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: Viatris Inc.
• Contact: Pushpa Baral
• Phone: +1 844 752 2069
• Email: pushpa.baral[@]indegene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after herniorrhaphy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 530
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Main Inclusion Criteria:

1. Requirement for unilateral open inguinal herniorrhaphy with mesh under general anesthesia.

3. Has an American Society of Anesthesiologists Physical Status of I, II, or III.

4. Pain Intensity (PI) using NRS-R =4 at any given timepoint during the 5 hours following end of surgery in the eligibility assessment as well as in the baseline assessment (NRS-R and NRS-A) immediately pre-dosing.

5. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 5 hours following end of surgery.

6. Able to understand and complete the study requirements (including literacy, to enable diary and questionnaire completion), provide written informed consent, and agree to abide by the study protocol and its restrictions.

Main Exclusion Criteria:

1. Previously dosed with this formulation of MR 107A 02.

2. Had any prior inguinal hernia repair in the past 24 months.

3. Has a planned concurrent surgical procedure (e.g., bilateral herniorrhaphy).

4. Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain that is not strictly related to the herniorrhaphy, and which may confound the postoperative assessments.

5. Known hypersensitivity to aspirin, NSAIDs, or other medication used in the study.

6. Body mass index (BMI) >40 kg/m2 at screening.

7. Body weight of <43 kg (105.8 lbs) at screening.

8. History of GI bleeding or peptic ulcer disease.

9. Known active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis.

10. A history of bleeding disorders that may affect coagulation.

11. Subjects with prior stroke or transient ischemic attack in the past 12 months prior to screening.

Related Conditions & MeSH terms

• Acute Pain
• Pain
• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• MR-107A-02
tablet
• Tramadol
over-encapsulated tablet
• Placebo
over-encapsulated tablet and/or tablet

Locations

Country	Name	City	State
United States	Investigator site 202	Anaheim	California
United States	Investigator site 207	Atlanta	Georgia
United States	Investigator site 212	Bellaire	Texas
United States	Investigator site 204	Houston	Texas
United States	Investigator site 211	Miami	Florida
United States	Investigator site 213	Phoenix	Arizona
United States	Investigator site 208	Riverside	California
United States	Investigator site 201	Salt Lake City	Utah
United States	Investigator site 203	San Antonio	Texas
United States	Investigator site 210	Sheffield	Alabama
United States	Investigator site 206	Tampa	Florida
United States	Investigator site 205	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Mylan Specialty, LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.	SPID based on a 0 to 10-point numeric rating scale with activity (NRS-A) for MR-107A-02 versus placebo.	48 hours after randomization
Secondary	Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo.	Number of doses of opioid rescue medication over the combined in-patient and outpatient treatment phases MR-107A-02 versus placebo.	7 days after randomization
Secondary	Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo.	Proportion of subjects using no opioid rescue medication over the combined in-patient and outpatient treatment phases MR-107A-02 versus placebo.	7 days after randomization
Secondary	Summed Pain Intensity Difference (SPID) for tramadol versus placebo.	SPID based on a 0 to 10-point numeric rating scale with activity (NRS-A) for tramadol versus placebo.	7 days after randomization
Secondary	Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol	SPID based on a 0 to 10-point numeric rating scale with activity (NRS-A) for MR-107A-02 versus tramadol.	48 hours after randomization