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
Scientific
Medical Oncology
Foothills Medical Centre
1331-29th Street NW
Calgary, Alberta
T2N 4N2
Canada
Study information
| Study design | A multicentre, randomized, double-blind, placebo-controlled, parallel-design trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | 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 |
| Study acronym | TTX |
| Study objectives | To 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) studied | Cancer- and cancer therapy-related pain |
| Intervention | Subcutaneous tetrodotoxin versus placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Tetrodotoxin (Tectin) |
| Primary outcome measure | 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 study start date | 30/12/2003 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 146 |
| Total final enrolment | 82 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 30/12/2003 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
Medical Oncology
Calgary, Alberta
T2N 4N2
Canada
T2N 4N2
Canada
Sponsor information
Wex Pharmaceuticals Inc (Canada)
Industry
Industry
Suite 2100-1040 West Georgia Street
Vancouver
V6E 4H1
Canada
| Phone | +1 604 683 8880 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
