| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 7.1 | | E.1.2 | Level | LLT | | E.1.2 | Classification code | 10022020 | |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial | PRIMARY OBJECTIVE
The primary objective is to evaluate the postoperative analgesic efficacy of a single instillation or subfascial/intramuscular injection of ALGRX 4975 1000 µg in subjects undergoing inguinal hernia repair. | |
| E.2.2 | Secondary objectives of the trial | SECONDARY OBJECTIVES
•To evaluate the safety and tolerability of a single administration of ALGRX 4975 1000 µg
•To evaluate the time to supplemental medication usage
•To evaluate the average daily VAS pain scores, assessed during movement upon arising in the morning and retiring in the evening, over the first 4 weeks postoperatively
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| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria | 1.The subject is male and aged 18 - 70 years.
2.The subject has a primary hernia and will undergo hernia repair by standard Lichtenstein mesh repair.
3.The subject is willing and able to understand the study procedures and the use of pain scales, and to communicate meaningfully with the study personnel.
4.The subject is in good health, with no unstable or uncontrolled medical conditions, as determined by the investigator on the basis of medical history, physical examination, and screening laboratory results.
5.The subject has signed the Informed Consent approved by the IRB/Ethics Committee.
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| E.4 | Principal exclusion criteria | 1.The subject has undergone a lower abdomen surgical procedure in the past.
2.The use of capsaicin, bupivacaine, tramadol, ibuprofen, or paracetamol is contraindicated in this subject (e.g., significant history of allergic reactions or intolerance to these or related substances).
3.The subject has a presence of any medical condition or instability that in the Investigator’s opinion could adversely impact their participation in the study or the collection of data, including chronic conditions that are likely to alter the rate of healing or are likely to result in safety complications unrelated to the study drug, such as uncontrolled diabetes mellitus (HbA1c > 9%).
4.The subject has a systolic blood pressure greater than 150 or diastolic blood pressure greater than 95 mm Hg, respectively.
5.The subject has personal or familial contraindications in undergoing general anesthesia.
6.The subject is taking digoxin, antiarrhythmics except beta blockers, warfarin, theophylline preparations, aminoglycosides, anticonvulsants except benzodiazepines, or lithium.
7.The subject has a medical condition, other than the one being studied that requires the use of a pain medication or CNS active drugs for pain such as tricyclic antidepressants. The use of low dose aspirin for cardiovascular prophylaxis is permitted.
8.The subject is currently scheduled to undergo bilateral inguinal hernia repair.
9.The subject has a history of drug or alcohol abuse within the past 2 years.
10.The subject is taking an antihypertensive agent that has not been at a stable dose for at least 4 weeks, or an antidepressant or psychotropic that has not been stable for at least 2 months. The subject is using an antidepressant as an analgesic.
11.The subject has taken an investigational medication within 3 months prior to the administration of study drug (Visit 2), or is scheduled to receive an investigational drug other than ALGRX 4975 while participating in the study.
12.The subject has previously participated in a clinical study with ALGRX 4975.
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| E.5 End points |
| E.5.1 | Primary end point(s) | Primary Efficacy Endpoint
The primary efficacy endpoint will be the average daily VAS pain scores, assessed during movement upon arising in the morning and retiring in the evening, during the first week after surgery. Subjects will be asked to measure their pain intensity, assessed during movement upon arising in the morning and retiring in the evening, on a 100 mm VAS. This pain measurement will be recorded the first time a subject arises from bed following the surgery, 4 hours after surgery, 8 hours after surgery (or upon retiring, if earlier), and each morning upon arising (approximately 08:00) and each evening prior to retiring (approximately 20:00) for the remainder of the study.
Safety Endpoints
Safety will be assessed using the results of physical examinations, vital signs, electrocardiography, wound healing evaluations, sensory mapping of the surgical area, clinical laboratory assessments, and adverse events.
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Information not present in EudraCT |
| E.6.2 | Prophylaxis | Information not present in EudraCT |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Information not present in EudraCT |
| E.6.7 | Pharmacodynamic | Information not present in EudraCT |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| E.6.9 | Dose response | Information not present in EudraCT |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description | |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
| E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 | The trial involves single site in the Member State concerned | Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | | The end of the trial is defined as the date at which the last subject completes the last telephone contact | |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 9 |
| E.8.9.1 | In the Member State concerned days | |
