Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
WEX-014
Study information
Scientific title
Acronym
TTX
Study hypothesis
To determine whether subcutaneous tetrodotoxin is more effective than placebo in reducing the intensity of cancer-related pain
Ethics approval
Not provided at time of registration
Study design
A multicentre, randomized, double-blind, placebo-controlled, parallel-design trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cancer- and cancer therapy-related pain
Intervention
Subcutaneous tetrodotoxin versus placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Tetrodotoxin (Tectin)
Primary outcome measures
Changes in pain intensity compared to baseline
Secondary outcome measures
1. Onset, peak, and duration of pain intensity reduction
2. Changes in the impact of pain on emotional and physical function compared to baseline
Overall trial start date
30/12/2003
Overall trial end date
31/03/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male or female 18 years of age and over
2. In-patients or out-patients with a diagnosis of cancer
3. Stable but inadequately controlled pain with current therapy for at least two weeks
4. Patients must be experiencing somatic, visceral and/or neuropathic pain related to cancer
5. Pain intensity, assessed by Question #3 of the Brief Pain Inventory (BPI short form) meets the definition of 'moderate' (score of 4-5) or 'severe' (score of 6-10) pain
6. Life expectancy of >3 months
7. Ability to communicate well with the Investigator and to comply with the requirements of the entire study
8. Willingness to give written informed consent (prior to any study-related procedures being performed) and to be able to adhere to the study restrictions, appointments, and examination schedule
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
146
Participant exclusion criteria
1. Planned initiation of chemotherapy, radiotherapy, or bisphosphonates within 30 days prior to randomization
2. Use of anaesthetics
3. Use of lidocaine and other types of antiarrhythmic drugs
4. Use of scopolamine and acetylcholinesterase-inhibiting drugs such as physostigmine
5. History of CO2 retention, or SaO2 <90% either on room air or O2 of not greater than 2-4 l/min by nasal cannula
6. Second or third degree heart block or prolonged QTc interval (corrected for rate) on screening electrocardiogram(ECG) (confirmed >450 msec on repeated occasion) or any other active cardiac arrhythmia or abnormality that could constitute a clinical risk
7. Coagulation or bleeding defects if in the opinion of the Investigator this represents a risk to the subject considering the subcutaneous (sc) route of administration
8. Known hypersensitivity to puffer fish, tetrodotoxin and/or its derivatives
9. Received an investigational agent within 30 days prior to screening or who is scheduled to receive an investigational drug other than tetrodotoxin during the course of the study
10. Previous use of tetrodotoxin
11. 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)
12. Females with a positive serum pregnancy test at screening or positive urine pregnancy test on admission to study site
13. 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
Recruitment start date
30/12/2003
Recruitment end date
31/03/2006
Locations
Countries of recruitment
Canada
Trial participating centre
Medical Oncology
Calgary, Alberta
T2N 4N2
Canada
Sponsor information
Organisation
Wex Pharmaceuticals Inc (Canada)
Sponsor details
Suite 2100-1040 West Georgia Street
Vancouver
V6E 4H1
Canada
+1 604 683 8880
wex@wexpharma.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Wex Pharmaceuticals Inc
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary