E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036236 |
E.1.2 | Term | Postoperative pain relief |
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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 |
The primary objective of this study is to assess the efficacy of pregabalin compared to placebo on acute pain at 24 hours following elective inguinal herniorraphy. |
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E.2.2 | Secondary objectives of the trial |
Evaluate the effect of pregabalin on pain with movement and at rest following surgery. Global Evaluation of Study Medication effects of pregabalin. Evaluate the safety and tolerability of pregabalin in the peri operative setting. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Male subjects between the ages of 18 and 75 years old. 2. The subject has provided written informed consent that must be obtained prior to admission to this study. 3. The subject will have elective open unilateral inguinal herniorrhaphy, using mesh Lichtenstein under general anesthesia or Monitored Anesthesia Care and fentanyl or sufentanil/propofol initiation and sevoflurane, isoflurane or desflurane as required for maintenance + local anesthetic infiltration at the conclusion of surgery. Study surgery should be anticipated to be in the morning (ie, preoperative dose 2 given at latest noon). 4. Expected to be able to use and tolerate NSAIDs, tramadol, oxycodone, and acetaminophen/paracetamol for postoperative pain control. 5. The subject will be available for a visit within -30 to -1 day of the day of surgery if not admitted the night before for baseline assessment and to receive study medication prior to the day before surgery. 6. The subject is expected and agrees to remain at the hospital (or intermediate care facility) for a minimum of 3 hours following surgery. 7. The subject’s preoperative health is graded as ASA P1 to P2 (See Appendix 1). 8. The subject is in satisfactory health as determined by the investigator on the basis of medical history, physical examination and laboratory results. 9. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 10. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. |
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E.4 | Principal exclusion criteria |
1.Subjects having additional procedures at the same time as the total inguinal herniorraphy. 2.Subjects with non elective or emergency surgery, or hernia with incarceration. 3.Subjects with hernia repair that is not a primary repair. 4.The planned use of nerve block or spinal/epidural/paravertebral anesthesia or surgery is not planned with general anesthesia or Monitored Anesthesia Care. 5.Subjects with a contraindication to the anesthesia agents indicated per protocol and general anesthesia. 6.Subjects who have been using any opioid medications for more than 2 weeks for pain control within three months of the Screening Visit. 7.Subjects with any cognitive impairment that would, in the investigator’s opinion, preclude study participation or compliance with protocol mandated procedures including careful completion of subject diary and treatment compliance. 8.Subjects with mobility or pain related illness that would limit assessment of sit, walk measures. 9.Subjects with a history of known alcohol, analgesic, or narcotic abuse (according to DSM IV criteria) within 12 months prior to Screening. 10.Subjects with a history of clinically significant intolerance or hypersensitivity to pregabalin, gabapentin, oxycodone, NSAID’s, Tramadol, or acetaminophen/paracetamol, and/or any analgesic which has a cross sensitivity to the medications used in this study. 11.Subjects that had active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 60 days prior to surgery. 12.Use of prohibited medications as listed in the protocol in the absence of appropriate washout phase or the likelihood of requiring treatment during the study period with drugs not permitted by the study protocol. 13.Subjects with a history of upper GI track ulcer/bleeding, myocardial infarction, unstable myocardial ischemia (angina), deep venous thrombosis or pulmonary embolism within three months of surgery. 14.Subjects considered clinically significantly volume depleted in the opinion of the Investigator. 15.Subjects that had inflammatory bowel disease, chronic or acute renal or hepatic disorder, or a significant coagulation defect. 16.Subjects with a history or recurrent presence of asthma or bronchospasm which requires treatment with glucocorticoids. 17.Subjects with a history of uncontrolled chronic disease that, in the opinion of the investigator, would contraindicate study participation or confound interpretation of results. Examples include clinically significant chronic pain conditions such as post herpetic neuralgia, painful diabetic peripheral neuropathy, and fibromyalgia as well as chronic neurological disorders such as stroke, Parkinson’s disease or Multiple Sclerosis. 18.Subject’s preoperative health graded as ASA P3 or higher 19.Subjects treated for cancer (ie, surgery, chemotherapy, radiation therapy, etc.) and/or in remission for any cancer other than basal cell carcinoma or squamous cell carcinoma within 2 years of screening. 20.Subjects who received pregabalin within 30 days prior to the Screening Visit, or are scheduled to receive any investigational drug during the course of this study or within 30 days of screening. 21.Any clinically significant or unstable medical condition that, in the opinion of the investigator, would compromise participation in the study such as: a. Significant renal disease; b. Significant hepatic disease; c. Significant respiratory disorder; d. Significant hematologic disorders; e. Significant immunologic diseases; f. Unstable cardiovascular disease (See Appendix 3 of the protocol); g. Significant inflammatory or rheumatologic diseases; h. Active hepatitis B or C, HIV infection, or other significant infectious condition diagnosed within the past 3 months; i. Symptomatic peripheral vascular disease; j. Untreated endocrine disorders. 22-25 due to character limitation please refer to study protocol |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the worst pain reported by subjects (question 1 of the Modified Brief Pain Inventory – short form) on the first day (approximately 24 hours) after the surgery is completed. |
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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 | No |
E.6.4 | Safety | Yes |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
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
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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 | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |