Clinical trial NCT06215859: Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain
Post Operative Pain
Pain
Keywords: Pain
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mylan Specialty, LP
First posted: 2024-01-22
Enrollment: 579
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.
timeFrame: 48 hours after randomization
Secondary outcomes:
measure: Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo.
timeFrame: 7 days after randomization
measure: Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo.
timeFrame: 7 days after randomization
measure: Summed Pain Intensity Difference (SPID) for tramadol versus placebo.
timeFrame: 7 days after randomization
measure: Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol
timeFrame: 48 hours after randomization
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Investigator site 210
state: Alabama
city: Phoenix
country: United States
facility: Investigator site 213
state: Arizona
city: Anaheim
country: United States
facility: Investigator site 202
state: California
city: Bakersfield
country: United States
facility: Investigator site 222
state: California
city: Riverside
country: United States
facility: Investigator site 208
state: California
city: Miami
country: United States
facility: Investigator site 211
state: Florida
city: Tampa
country: United States
facility: Investigator site 206
state: Florida
city: Atlanta
country: United States
facility: Investigator site 207
state: Georgia
city: Wichita
country: United States
facility: Investigator site 205
state: Kansas
city: Bellaire
country: United States
facility: Investigator site 212
state: Texas
city: Carrollton
country: United States
facility: Investigator site 215
state: Texas
city: Houston
country: United States
facility: Investigator site 204
state: Texas
city: McAllen
country: United States
facility: Investigator site 216
state: Texas
city: San Antonio
country: United States
facility: Investigator site 219
state: Texas
city: San Antonio
country: United States
facility: Investigator site 203
state: Texas
city: San Antonio
country: United States
facility: Investigator site 214
state: Texas
city: Salt Lake City
country: United States
facility: Investigator site 201
state: Utah
city: Eau Claire
country: United States
facility: Investigator site 224
state: Wisconsin
Study officials:
affiliation: Viatris Inc.
name: Susanne Vogt
role: STUDY_DIRECTOR
References: