Full title of the trial: A 9 Week, Randomized, Double-Blind, placebo-controlled, Multicenter, Study of Pregabalin (BID) in subjects with posttraumatic peripheral neuropathic pain

• Register: EUCTR
• Last refreshed on: 18 April 2012
• Main ID: EUCTR2005-003048-78-FI
• Date of registration: 11/11/2005
• Prospective Registration: Yes
• Primary sponsor: Pfizer Oy
• Public title: Full title of the trial: A 9 Week, Randomized, Double-Blind, placebo-controlled, Multicenter, Study of Pregabalin (BID) in subjects with posttraumatic peripheral neuropathic pain
• Scientific title: Full title of the trial: A 9 Week, Randomized, Double-Blind, placebo-controlled, Multicenter, Study of Pregabalin (BID) in subjects with posttraumatic peripheral neuropathic pain
• Date of first enrolment: 22/12/2005
• Target sample size: 260
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-003048-78
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: Single blind: yes Double blind: yes Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: yes Other:

Countries of recruitment

Denmark, Finland, Italy, Portugal, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
·Male or female subjects, ages between 18-80 years;
·Signed and dated informed consent;
·Females of childbearing potential must have a negative serum ß-HCG pregnancy test and be practicing an effective form of contraception (accepted methods are hormonal [oral contraceptive or injectable contraceptive], double barrier with spermicide, or intrauterine device-IUD). Complete abstinence may be considered acceptable, but must first be discussed on a case-by-case basis with the Pfizer Clinical Study Operation Manager/Project Manager or Clinician prior to any screening tests or procedures for the study;
·Diagnosis of Posttraumatic Peripheral Neuropathic Pain (NeP) syndrome, including post-surgical NeP, NeP due to peripheral nerve injury, and phantom limb pain, confirmed by a qualified pain specialist and persisting for a minimum of 3 months following the traumatic event;
·Must complete =4 daily pain diaries during the last week of the screening period prior to randomization;
·Must have a daily mean pain score of =4 over the screening period prior to randomization based on Daily Pain Rating Scale (DPRS);
·Must have a score of >40 mm on the Visual Analogue Scale (VAS) of the SF-MPQ.
·Screening laboratory values within normal limits, or abnormalities clinically insignificant in the judgment of the investigator; and
·Deemed capable of complying with study schedule, procedures and medications.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects presenting with any of the following will not be included in the trial:
·Pregnant or lactating women or women of childbearing potential not using acceptable method of contraception;
·Subjects with neuropathic pain that is not due to trauma; eg, subjects with DPN, PHN, radiculopathy, trigeminal neuralgia (TGN), or carpal tunnel syndrome (CTS);
·Subjects whose posttraumatic neuropathic pain is central rather than peripheral (eg, spinal cord injury);
·Subjects whose posttraumatic neuropathic pain is due to Complex Regional Pain Syndrome (CRPS, Type I or Type II);
·Skin conditions in the affected dermatome that (in the judgment of the investigator) could interfere with evaluation of neuropathic pain condition;
·Current or past DSM-IV-TRTM (2000) diagnosis of schizophrenia, psychotic disorder, bipolar affective disorder or obsessive-compulsive disorder, and Major Depressive Disorder (MDD);
·Current or past DSM-IV-TRTM (2000) diagnosis of substance abuse or dependence within the last 6 month;
·Use of gabapentin during the study. Discontinuation of gabapentin at the screening visit is permitted;
·Initiate specific behavioural or supportive therapy for any anxiety disorder post randomization;
·Clinically significant or unstable conditions that, in the opinion of the investigator, would compromise participation in the study. This includes, for example, medical conditions such as, but not limited to: hepatic, renal, respiratory, hematologic, immunologic, or cardiovascular diseases (eg, myocardial infarction within previous month, ventricular arrhythmia recent severe heart insufficiency), inflammatory or rheumatologic disease, active infections, symptomatic peripheral vascular disease, and untreated endocrine disorders;
·History of seizure disorder, except febrile seizures of childhood;
·Any other condition, which in the investigator’s judgment might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study. This includes any condition precluding pregabalin use;
·Malignancy within past 2 years with exception of basal cell carcinoma;
·Urine screen positive for illicit substances at screening (Visit 1);
·Have ever received treatment with vigabatrin, hydroxychloroquine, deferoxamine, thiorizidine and or any compound known to adversely affect retina and visual fields;
·CLcr =60 mL/min (estimated by the central laboratory from serum creatinine, body weight, age, and sex using the Cockroft-Gault equation. (See Appendix A);
·White blood cells (WBC) <2500/mm³; neutrophil count <1500/mm³; platelet count <100 x10³/mm³;
·Liver function tests >3 x the upper limit of normal is considered clinically significant;
·A previous history of intolerance or hypersensitivity to pregabalin, gabapentin or drugs with similar chemical structure;
·Galactose intolerance, lactase deficiency and/or any other malabsorption syndromes;
·Anticipated need for surgery during the study or within 4 weeks of completion;
·Anticipated need for general anesthetics during the course of the study;
·Anticipated need for hospitalization for any reason during the course of the study or within 4 weeks of completion;
·Participation in a previous pregabalin clinical trial or previous prescribed use of pregabalin (in countries where it is commercially available);
·Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study; and/or
·Emp

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Posttraumatic peripheral neuropathic pain in adults
Classification code 10054095

Intervention(s)

Trade Name: Lyrica
Product Name: Pregabalin
Product Code: PD 0144723 (CI-1008)
Pharmaceutical Form: Capsule*
INN or Proposed INN: Pregabalin
Other descriptive name: (S)-(+)-3-isobutyl-GABA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Trade Name: Lyrica
Product Name: Pregabalin
Product Code: PD 0144723 (CI-1008)
Pharmaceutical Form: Capsule*
INN or Proposed INN: Pregabalin
Other descriptive name: (S)-(+)-3-isobutyl-GABA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Trade Name: Lyrica
Product Name: Pregabalin
Product Code: PD 0144723 (CI-1008)
Pharmaceutical Form: Capsule*
INN or Proposed INN: Pregabalin
Other descriptive name: (S)-(+)-3-isobutyl-GABA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Weekly Mean Pain Score at end of Week 8 (V7 or early termination, LOCF) from Daily Pain Diary

Secondary Objective: To evaluate the effects of pregabalin in comparison to placebo on co-morbid symptoms, particularly anxiety, in subjects with post traumatic peripheral neuropathic pain

Main Objective: To evaluate the efficacy of pregabalin compared to placebo in the treatment of post traumatic peripheral neuropathic pain.

Secondary ID(s)

2005-003048-78-SE

A0081064