| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Chronic post-traumatic peripheral neuropathic pain |
|
| E.1.1.1 | Medical condition in easily understood language |
| Peripheral neuropathic pain |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10054095 |
| E.1.2 | Term | Neuropathic pain |
| E.1.2 | System Organ Class | 100000004852 |
|
| 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 |
| To evaluate the efficacy of pregabalin (150-600 mg/day) compared with placebo in the treatment of chronic post-traumatic peripheral neuropatic pain |
|
| E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy of pregabalin compared with placebo to improve global assessment, functional status and sleep in the treatment of chronic post-traumatic peripherela neuropathic pain.
- To assess the safety and tolerability of pregabalin in the treament of chronic post-traumatic peripheral neuropathic pain. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
2. Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, daily pain and sleep diary (recorded via interactive voice response system [IVRS]), and other study procedures.
3. Subjects must be literate in the language used in the IVRS and in the assessments/forms. In addition, subjects must have the ability (unaided) to understand and correctly use the IVRS and complete all required assessments/forms. In addition, subjects must have the ability (unaided) to understand and correctly use the IVRS, have daily access to a telephone in order to complete the IVRS assessments each day, perform telephone visits and complete all required assessments/forms. It is the responsibility of the investigator to ensure subjects are adequately and appropriately trained with respect to proper use of the IVRS and completion all non-electronic (ie, paper) assessments.
4. Men or women of any race or ethnicity who are at least 18 years of age.
5. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment (See section 4.3). A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
6. Subject must have chronic peripheral neuropathic pain present for more than 6 months after a traumatic or surgical event per medical history (this may include, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury).
7. In addition, to be eligible for inclusion in the study, all subjects must:
a. Have a score ≥4 on a Weekly Pain Numeric Rating Scale (NRS) at Visit 1; and
b. Have completed at least 4 daily pain diaries during Screening during the 7 days prior to Visit 2 with a mean pain score of ≥4 and ≤9 based on Daily Pain NRS to be eligible for randomization.
c. Must have their implicated peripheral nerve(s) identified.
d. Must meet criteria for neuropathic pain assessment as described in Section 7.2.3.1.
|
|
| E.4 | Principal exclusion criteria |
Subjects presenting with ANY of the following will NOT be included in the study:
1. Subjects with neuropathic pain due to DPN, PHN, HIV, trigeminal neuralgia (TGN), or carpal tunnel syndrome (CTS); subjects whose post-traumatic neuropathic pain is categorized as central (eg, spinal cord injury) rather than
peripheral.
2. Subjects with pain due to Complex Regional Pain Syndrome (CRPS, Type I or Type II).
3. Subjects with skin conditions in the affected dermatome that in the judgment of the investigator could interfere with evaluation of the neuropathic pain condition.
4. Subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain; subjects with significant somatic pain at the site of their trauma that may confound assessment or self-evaluation of their neuropathic pain.
5. Subjects who have failed pregabalin treatment due to lack of efficacy with an adequate course of therapy at doses ≥150 mg/day, have hypersensitivity or intolerance to pregabalin or gabapentin, or who have participated in a pregabalin clinical trial at any time; subjects treated with pregabalin at any time during the 6 month period prior to the Screening visit (V1). Subjects previously treated with pregabalin may be eligible to participate in the study if they meet all protocol-specified criteria.
6. Any subject considered at risk of suicide or self-harm based on investigator judgment and/or the details of a risk assessment, as specified in Section 7.3.
7. Use of prohibited medications in the absence of appropriate washout periods (see Section 5.5).
8. Participation in any other clinical trial within the 30 days prior to screening and/or during participation in this study.
9. Subjects with epilepsy; pernicious anemia; hematologic illnesses; known HIV infection; any clinically unstable cardiovascular (including a myocardial infarction in the 3 months prior to Visit 1), hematological, autoimmune, endocrine, renal, hepatic (including chronic hepatitis B, hepatitis B within the past 3 months), respiratory, or gastrointestinal disease; symptomatic peripheral vascular disease including intermittent claudication; uncontrolled diabetes mellitus, untreated hypothyroidism.
10. Subjects who have had a diagnosis of malignancy other than basal cell carcinoma or carcinoma in situ of the cervix within the past 5 years.
11. Subjects with creatinine clearance (CLcr) ≤60 mL/min (estimated prior to Visit 2 from serum creatinine obtained at Visit 1, body weight, age, and gender using the Cockcroft and Gault equation; see Section 7.2.1; Subjects who have an estimated CLcr ≤60 mL/min by this screening method may have their CLcr measured, at the investigator’s discretion, with a 24-hour urine collection performed at the central laboratory. If this 24-hour urine CLcr is >60 mL/min, the subject may be included.
12. Abnormal clinically significant electrocardiogram (ECG).
13. Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 28 days after the last dose of investigational product.
14. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality, or other factors that may increase the risk associated with study participation or investigational product administration or may interfere with compliance or the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate to participate in the study.
15. Subjects with a current diagnosis of DSM-IV-TR Axis I disorder (including, for example, schizophrenia, bipolar disorder, other psychotic disorders such as schizoaffective disorder and delusion disorder, somatoform disorders or factitious disorders, or bipolar disorders in the past 2 years); however, diagnoses of Generalized Anxiety Disorder (GAD) or major depression (MDD) that is clinically stable are allowed.
16. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
17. Subjects with pending Worker’s Compensation, Worker’s Compensation, civil litigation or disability claims pertinent to the subject based upon trauma; current involvement in out-of-court settlements for claims pertinent to subject’s trauma;
Subjects with fully resolved litigation and compensation claims can participate. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Primary Efficacy Endpoint:
- Endpoint mean pain based on the NRS pain scores from the daily pain diaries while receiving study medication. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
Secondary Efficacy Endpoints:
- Patient Global Impression of Change (PGIC);
- Brief Pain Inventory (BPI-sf);
- EuroQoL 5-Dimensions (EQ-5D);
- Daily Sleep Interference Rating Scale (SIRS);
- Medical Outcomes Study Sleep Scale (MOS-SS) total score and each sub-domain;
- Treatment response: Reductions in endpoint mean pain of ≥30% and ≥50%. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| 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 |
|
| 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) | 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.8.2.4 | Number of treatment arms in the trial | 2 |
| 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 | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 50 |
| 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 | No |
| 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 |
| Belgium |
| Bulgaria |
| Croatia |
| Denmark |
| Germany |
| Hungary |
| Korea, Republic of |
| Sweden |
| Israel |
| Poland |
| Romania |
| South Africa |
| Ukraine |
| United States |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| 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 | 0 |
| E.8.9.1 | In the Member State concerned months | 7 |
| 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 | 10 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
Print
