A multicentre, randomized, double-blind, placebo-controlled, parallel-design trial of the efficacy and safety of subcutaneous tetrodotoxin (Tectin) for moderate to severe inadequately controlled cancer-related pain

ISRCTN ISRCTN75684296
DOI https://doi.org/10.1186/ISRCTN75684296
Secondary identifying numbers WEX-014
Submission date
17/10/2005
Registration date
07/11/2005
Last edited
12/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Neil Hagen
Scientific

Medical Oncology
Foothills Medical Centre
1331-29th Street NW
Calgary, Alberta
T2N 4N2
Canada

Study information

Study designA multicentre, randomized, double-blind, placebo-controlled, parallel-design trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA multicentre, randomized, double-blind, placebo-controlled, parallel-design trial of the efficacy and safety of subcutaneous tetrodotoxin (Tectin) for moderate to severe inadequately controlled cancer-related pain
Study acronymTTX
Study objectivesTo determine whether subcutaneous tetrodotoxin is more effective than placebo in reducing the intensity of cancer-related pain
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCancer- and cancer therapy-related pain
InterventionSubcutaneous tetrodotoxin versus placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Tetrodotoxin (Tectin)
Primary outcome measureChanges in pain intensity compared to baseline
Secondary outcome measures1. Onset, peak, and duration of pain intensity reduction
2. Changes in the impact of pain on emotional and physical function compared to baseline
Overall study start date30/12/2003
Completion date31/03/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants146
Total final enrolment82
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment30/12/2003
Date of final enrolment31/03/2006

Locations

Countries of recruitment

  • Canada

Study participating centre

Medical Oncology
Calgary, Alberta
T2N 4N2
Canada

Sponsor information

Wex Pharmaceuticals Inc (Canada)
Industry

Suite 2100-1040 West Georgia Street
Vancouver
V6E 4H1
Canada

Phone +1 604 683 8880
Email wex@wexpharma.com
Website http://www.wexpharma.com

Funders

Funder type

Industry

Wex Pharmaceuticals Inc

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2008 12/01/2021 Yes No

Editorial Notes

12/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.