Pain relief study for hernia patients pulled before start
NCT ID NCT06709612
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to test a new pain medicine called AMT-143 for people recovering from hernia repair surgery. It was designed to find the right dose to safely reduce pain after the operation. However, the study was withdrawn before any participants were enrolled, so no results are available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Expected to start
-
Jan 2025
An estimate. Start dates often move.
- Expected to finish
-
May 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: The following inclusion criteria apply to all participants scheduled for open inguinal hernia repair in all cohorts. 1. Provides voluntary written informed consent. 2. Participants are ≥18 years of age at screening. 3. Scheduled to undergo unilateral open inguinal hernia repair. 4. Body mass index (BMI) ≤40.0 kg/m2. 5. Male participants must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study until at least 1 week after the administration of study medication. 6. Female participants: * Not pregnant (female participant of childbearing potential must have a negative urine pregnancy test before surgery). * Not lactating. * Not planning to become pregnant during the study. * Be surgically sterile; or at least two years post-menopausal; or have a monogamous partner who is surgically sterile; or is practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by Health Canada for greater than 2 months prior to screening visits and commits to the use of an acceptable form of birth control for the duration of the study. 7. In the opinion of the Investigator, is willing and able to understand the study procedures, and agrees to adhere to the requirements of the study protocol, in order to enable accurate and appropriate responses to pain scales. Exclusion Criteria: The following exclusion criteria apply to all participants in all cohorts. 1. Have chronic pain and have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of study treatment initiation. 2. History of hypersensitivity to any ingredient in the formulation (hyaluronan or methylcellulose). 3. History of hypersensitivity or allergy to amide type local anaesthetics (lidocaine, bupivacaine, or ropivacaine). 4. History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker. 5. Have a clinically significant abnormal clinical laboratory test value, according to the judgement of the investigator. 6. Have a clinically significant 12-lead ECG abnormality, according to the judgement of the investigator. 7. Have received any medications with a potential for drug interactions with ropivacaine (i.e., amide-type local anaesthetics such as lidocaine, bupivacaine, mepivacaine and prilocaine; antiarrhythmics such as procainamide, disopyramide, tocainide, mexiletine and flecainide; sedative; strong inhibitors of cytochrome P4501A2 such as fluvoxamine enoxacin, theophylline and imipramine for at least 5 half-lives prior to the start of this). 8. Have received any investigational product within 30 days before dosing with study medication. 9. Suspected or known history of substance abuse and/or alcoholism.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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