CompletedPhase 2

Pilot Herniorrhaphy Study for Postoperative Analgesia

United States463 participantsStarted 2015-07

Plain-language summary

A Phase 2, Randomized, Pilot Study to Investigate the Safety, Efficacy, Pharmacokinetics and Bioavailability of HTX-011, HTX-002, or HTX-009 Administered Via Injection and/or Topical Application Following Unilateral Open Inguinal Herniorrhaphy

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Be male or female 18 years of age or older.
✓. Female subjects are eligible only if all of the following apply:
✓. Plan to undergo a unilateral inguinal herniorrhaphy
✓. Have the ability and be willing to comply with the study procedures
✓. Must be able to understand study procedures and give informed consent for the conduct for all study procedures, using an IRB approved consent form.

Exclusion criteria

✕. Unwilling to sign informed consent or not willing or able to complete all study procedures
✕. Have a contraindication or be allergic to any medication to be used during the trial period
✕. Have clinically significant cardiac abnormalities, that in the opinion of the investigator would pose a health risk to the subject should they participate in the trial
✕. Have American Society of Anesthesiologists (ASA) Physical Status classification system category 4 or greater (Appendix E)
✕. Have clinically significant renal or hepatic abnormalities (defined as an AST or ALT \> 3x ULN, creatinine \> 2x ULN)
✕. Have another painful condition that may confound pain assessments
✕. Have another surgery planned within 30 days of procedure, or presents with bilateral or recurrent inguinal hernia, other hernia presentations, or hernias with large scrotal component that would be difficult to reduce surgically
✕. Have a known or suspected history of alcohol or drug abuse, or a positive drug screen

What they're measuring

Mean Summed Pain Intensity (SPI) Score

Timeframe: 24 hours

Trial details

NCT IDNCT02504580

SponsorHeron Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-03

Results submitted2021-06-14

View on ClinicalTrials.gov More Postoperative Pain trials