Condition category
Cancer
Date applied
17/10/2005
Date assigned
07/11/2005
Last edited
29/03/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Neil Hagen

ORCID ID

Contact details

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

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

http://www.wexpharma.com

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

Publication citations

Additional files

Editorial Notes