Status:
COMPLETED
Safety & Efficacy Study of Subcutaneous Tetrodotoxin for Moderate to Severe Inadequately Controlled Cancer-related Pain
Lead Sponsor:
Wex Pharmaceuticals Inc.
Conditions:
Pain
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Different pathophysiologic mechanisms are responsible for the development of chronic pain disorders. Pain pathways are triggered in part by ectopic discharges of voltage-sensitive sodium channels, whi...
Detailed Description
Study Objectives: Male or female subjects with moderate to severe pain (related to cancer or cancer treatment)inadequately controlled by current therapy: Primary Objectives: * To compare the effica...
Eligibility Criteria
Inclusion
- Inclusion criteria
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Male or female 18 years of age and over.
- Inpatient or outpatient with a diagnosis of cancer.
- Stable but inadequately controlled pain with current therapy for at least two weeks.
- Experiencing somatic, visceral and/or neuropathic pain related to cancer.
- Baseline pain intensity, as assessed by Question #3 of the Brief Pain Inventory (BPI) that meets the definition of "moderate" (score of 4-5) or "severe" (score of 6-10) pain.
- Life expectancy of at least 3 months.
- Ability to communicate well with the investigator and to comply with the requirements (restrictions, appointments, and examination schedule) of the entire study.
- Signed informed consent document (prior to any study-related procedures being performed).
- Exclusion criteria
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Planned initiation of chemotherapy, radiotherapy, or bisphosphonates within 30 days prior to randomization.
- Use of anaesthetics.
- Use of lidocaine and other types of antiarrhythmic drugs.
- Use of scopolamine and acetylcholinesterase-inhibiting drugs such as physostigmine.
- History of CO2 retention, or SaO2 \<80% either on room air or O2 of not greater than 2-4 L/min by nasal cannula.
- Second- or third-degree heart block or prolonged QTc interval (corrected for rate) on screening ECG (confirmed \> 450 msec on repeated occasion) or any other active cardiac arrhythmia or abnormality that could constitute a clinical risk.
- Coagulation or bleeding defects if, in the opinion of the investigator, this represents a risk to the subject considering the subcutaneous (s.c.) route of administration.
- Known hypersensitivity to puffer fish, tetrodotoxin and/or its derivatives.
- Use of an investigational agent within 30 days prior to screening or is scheduled to receive an investigational drug other than tetrodotoxin during the course of the study.
- Females who are lactating or at risk of pregnancy (i.e., sexually active with fertile males and not using an adequate form of birth control).
- Females with a positive serum pregnancy test at screening or positive urine pregnancy test on admission to study site.
- Any other condition that, in the opinion of the investigators, is likely to interfere with the successful collection of the measures required for the study or poses a risk to the patient.
- Men with glomerular filtration rate (GRF) less than 60 mL/min/1.73 m2 and women with GFR less than 50 mL/min/1.73 m2
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00725114
Start Date
April 1 2008
End Date
November 1 2012
Last Update
July 9 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
WEX Pharmaceuticals Inc.
Vancouver, British Columbia, Canada, V6C 1G8