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

Pain Clinical Trial

Official title:

A 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 Bunionectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06215820
• Other study ID #: MR-107A-02-TFZ-3001
• Status: Recruiting
• Phase: Phase 3
• Start date: December 29, 2023
• Est. completion date: September 2024

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 bunionectomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 405
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Requirement for a primary unilateral bunionectomy

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

3. Pain Intensity (PI) using a Numeric Rating Scale (NRS-R) =4 at any given timepoint during the 9 hours after removal of the popliteal sciatic block

4. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 9 hours after removal of the popliteal sciatic block

5. 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.

Key Exclusion Criteria:

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

2. Subjects with a contralateral foot bunionectomy in the past 6 months.

3. Subject has a 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 bunionectomy, and which may confound the postoperative assessments.

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

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

6. Body weight of <43 kg at screening.

7. History of GI bleeding or peptic ulcer disease.

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

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

10. 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 103	Anaheim	California
United States	Investigator site 109	Atlanta	Georgia
United States	Investigator site 113	Bellaire	Texas
United States	Investigator site 107	Carrollton	Texas
United States	Investigator site 106	Houston	Texas
United States	Investigator site 111	McAllen	Texas
United States	Investigator site 112	Miami	Florida
United States	Investigator site 104	O'Fallon	Illinois
United States	Investigator site 102	Pasadena	Maryland
United States	Investigator site 115	Phoenix	Arizona
United States	Investigator site 110	Riverside	California
United States	Investigator site 101	Salt Lake City	Utah
United States	Investigator site 105	San Antonio	Texas
United States	Investigator site 114	Sheffield	Alabama
United States	Investigator site 108	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mylan Specialty, LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Summed Pain Intensity Difference (SPID) for tramadol versus placebo.	SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) for tramadol versus placebo.	48 hours after randomization
Other	Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol	SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) for MR-107A-02 versus tramadol.	48 hours after randomization
Primary	Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.	SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) 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