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 pai

Not Applicable

Completed

• Conditions: Cancer- and cancer therapy-related pain; Cancer; Cancer pain

• Registration Number: ISRCTN75684296
• Lead Sponsor: Wex Pharmaceuticals Inc (Canada)

Brief Summary

2008 results in https://pubmed.ncbi.nlm.nih.gov/18243639/ (added 12/01/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-07
• Study Completion: 2006-03-31
• Last Update Posted: 25 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 82

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in pain intensity compared to baseline

Secondary Outcome Measures

Name	Time	Method
<br> 1. Onset, peak, and duration of pain intensity reduction<br> 2. Changes in the impact of pain on emotional and physical function compared to baseline<br>