Phase 2
Completed N=53
Efficacy, Safety and Pharmacokinetic Profile of a Collagen Bupivacaine Implant in Men After Open Mesh Herniorrhaphy
Source: ClinicalTrials.gov NCT00626886 ↗Enrolled (actual)
53
Serious AEs
3.8%
Results posted
Jan 2021
Primary outcomePrimary: Total Use of Opioid Rescue Analgesia Over 0 to 24 Hours — 18.48; 24.60 mg
Summary
The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after herniorrhaphy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Use of Opioid Rescue Analgesia Over 0 to 24 Hours |
18.48; 24.60 | — |
| SECONDARY Total Use of Opioid Rescue Analgesia Over 0 to 48 Hours |
30.60; 36.50 | — |
| SECONDARY Total Use of Opioid Rescue Analgesia Over 0 to 72 Hours |
37.20; 44.89 | — |
| SECONDARY Summed Pain Intensity VAS Scores (VAS at Rest and After Cough) |
413.8; 862.0; 395.0; 594.6; 251.5; 426.6 | — |
| SECONDARY Patient's Global Evaluation of the Study Treatment on a 5 Point Likert Scale |
12; 14; 8; 9; 3; 3 | — |
| SECONDARY VAS Pain Intensity Scores Over Time |
32.8; 48.2; 30.3; 52.9; 26.8; 49.6 | — |
| SECONDARY Categorical Pain Intensity Scores Over Time - AT REST |
1.0; 1.3; 1.6; 1.8; 1.4; 1.8 | — |
| SECONDARY Categorical Pain Relief Scores Over Time - AT REST |
1.8; 1.6; 1.9; 1.6; 1.9; 1.5 | — |
| SECONDARY Categorical Pain Intensity Scores Over Time (After Cough) |
1.2; 1.3; 1.8; 2.1; 1.6; 2.1 | — |
| SECONDARY Categorical Pain Relief Scores Over Time (After Cough) |
1.8; 1.6; 1.5; 1.3; 1.8; 1.4 | — |
Eligibility Criteria
Inclusion Criteria
- Has body mass index (BMI) > 19 and 7 days) before surgery. Patients who, in the Investigator's opinion, are developing opioid tolerance are to be excluded.
- Has impaired liver function, aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin ≥ 3.0 times the upper limit of normal (ULN), active hepatic disease, evidence of clinically significant liver disease or another condition (eg, alcoholism, cirrhosis or hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with exposure to test article.
- Has any clinically significant unstable cardiac, neurological, immunological, renal or hematological disease or any other condition that, in the opinion of the Investigator, could compromise the patient's welfare, ability to communicate with the study staff or otherwise contraindicate study participation.
- Is judged by the Investigator to be at risk for infection or slow wound healing.
- Has a chronic painful condition that might confound the assessment of pain associated with the herniorrhaphy.
- Routinely uses pain medication that, in the opinion of the Investigator, could confound the pain assessments during the study.
- Has been treated with agents that could affect the analgesic response (such as central alpha agents, neuroleptic agents and other antipsychotic agents) within 2 weeks of surgery.
- Has been treated with monoamine oxidase inhibitors (MAOIs) within 10 days of surgery.
- Has been treated with systemic corticosteroids within 7 days of surgery (inhaled and topical corticosteroids are allowed).
- Has participated in a clinical trial within 30 days of surgery.
Data sourced from ClinicalTrials.gov (NCT00626886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.