E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative Pain Due to the Plastic Surgery of the Breast |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Information not present in EudraCT |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this double-blind, vehicle-controlled trial is to test the analgesic efficacy and safety of the sterile 5 % lidocaine patch for treatment of postoperative pain, specifically due to plastic surgery of the breast. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Healthy females 18-60 years of age with a planned surgery for plastic surgery of the breast; Agrees to sign and date an Ethics Committee approved informed consent; Must be undergoing plastic surgery of both breasts for reduction or enlargement; In good health on the basis of medical history, physical examination, ECG and routine laboratory tests per the judgement of the clinicial; Is reliable and mentally competent to complete study diaries; Agrees to use the study medication as required by the protocol; I able to read, speak and understand Latvian, Russian or English; Is using an acceptable birth control method; Is available for the study visits and telepfone checks during the duration of treatment (6-8 days following surgery) |
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E.4 | Principal exclusion criteria |
Females with any malignancy or suspected malignancy, or has received treatment for a malignancy within the past 5 years, Has used analgesics, steroids, or sedatives in the treatment of the chronic disease within the past 3 months, Has a history of hypersensivity to lidocaine, aspirin or other analgesics, has chronic renal or hepatic disease having serum creatinine levels 1.25 times above the upper limit of normal and AST/ALT levels 1.5 times above the upper limit of normal, Smokes more than 15 cigarettes per day, Is a known alchocol or drug abuser, Needs more extensive surgery such as mastectomy or reconstruction of the breast, Is having breast augmentation via transaxial or transumbilical incisions, Has had previous surgery in the same area, Has participated in any other clinivcal trial within the past 60 days, Clinical evidence of any sinificant chronic illness; Any condition that the Investigator believes would interfere with evaluation of the subject or may put the subject at undue risk. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time-to-Pain Resolution will be defined as the time of the initial patch application to when the subject records the fourth consecuitive Categorical Pain Score of 2 or less on the Categorical Pain Scale. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |