Prospective, single-blind, placebo-controlled, three-treatment, three-period, adaptive multi-centre Phase IIa (proof-of-concept) trial to investigate the efficacy, safety, and tolerability of Ketamine HCl PR tablets in patients with chronic non-malignant neuropathic pain

Develco Pharma Schweiz AG0 sites70 target enrollmentFebruary 10, 2015

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Develco Pharma Schweiz AG
Enrollment: 70
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 10, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Develco Pharma Schweiz AG

Eligibility Criteria

Inclusion Criteria

•1\. Male and female patients \=18 years of age at Visit 1 (Screening)
•2\. Patients with a documented history of chronic non\-malignant neuropathic pain at Visit 1
•3\. Patients with a DN4 Neuropathic Pain Diagnostic Questionnaire score of \=4 at Visit 1
•4\. Stable individual regular standard treatment regimen for chronic neuropathic pain, i.e. no change in drug and non\-drug treatments for at least two weeks prior to Visit 1 and anticipated to remain stable until the end of the single\-blind treatment phase. Use of rescue medication for neuropathic pain (including topical treatments, physical measures etc.) or any other co\-medication used on an as\-needed” basis that might affect pain perception or pain intensity as well as opioids as part of the regular standard treatment are not allowed in this trial.
•5\. Patients with inadequate pain control (mean current” PI on VAS \>50 mm) by their current individual standard treatment regimen on at least three days of the seven\-day screening phase (to be checked at Visit 2\)
•6\. Patients willing and able (e.g. mental and physical condition) to participate in all aspects of the trial, including use of medication, completion of subjective evaluations, attending scheduled visits, completing telephone contacts, and compliance with protocol requirements as evidenced by providing signed written informed consent at Visit 1
•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 50

Exclusion Criteria

•1\. Hypersensitivity or intolerance to ketamine or any of the excipients
•2\. Patients treated with any other ketamine preparation within the last month prior to Visit 1
•3\. Patients receiving opioids , regardless if as part of their individual standard treatment regimen for chronic neuropathic pain or in context with any other indication, within the last two weeks prior to Visit 1
•4\. Patients with untreated or uncontrolled arterial hypertension (sitting systolic blood pressure at rest \=160 mmHg and/or sitting diastolic blood pressure at rest \=90 mmHg)
•5\. History of cerebrovascular event (stroke, PRIND, TIA) within the previous six months prior to Visit 1
•6\. Known or suspected cardiac disease, especially coronary artery disease (e.g. unstable angina, congestive heart failure), tachyarrhythmia and history of myocardial infarction
•7\. Known or suspected hypovolemia or dehydration
•8\. Known or suspected hyperthyroidism or patients receiving thyroid replacement therapy within the last two weeks prior to Visit 1
•9\. Concomitant treatment with theophylline or aminophylline within the last two weeks prior to Visit 1
•10\. Long\-term therapy for any chronic disease, if suspected to be unstable during the course of the trial