E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post Thoracotomy Pain Syndrome (PTPS) |
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E.1.1.1 | Medical condition in easily understood language |
Chronic pain in relation to the scar om the chest wall following thoracic surgery, which persists for more six months after surgery. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Determine recruitment potential among cured lung cancer patients with chronic pain following lung surgery for an RCT and if our method of Onabotulinum toxin A administration is feasible and acceptable to the test subjects. |
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E.2.2 | Secondary objectives of the trial |
Early stage testing of the hypothesis that chronic pain following thoracic surgery can be treated using method.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients of 18 years of age or above. 2. Patients who have undergone pulmonary surgery because of suspicion or confirmed pulmonary malignancies. 3. Patients who are radically treated for pulmonary malignancy 4. Patients who suffers from chronic pain or unpleasant sensations at the site of scar at least six months after surgery with fully healed surgical wounds. |
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E.4 | Principal exclusion criteria |
1. Patients who cannot understand oral and written information. 2. Patients who were not radically operated. 3. Patients with other concomitant or other active cancer diseases. 4. Patients with chronic pain in the chest wall prior to surgery. 5. Pregnant women or women planning to get pregnant in the study period. 6. Patients with autoimmune neuromuscular diseases, sclerosis, peripheral neuromuscular disturbances and general muscle weakness or atrophy. 7. Patients with intolerance or allergy to BOTOX®. 8. Patients who are at present treated with Onabotulinum toxin A or similar neuromuscular blocking drug or have received such in the past year. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Recruitment of 30 test subjects. 2. Half of the first half of included test subject must complete the treatment. 3. Half of test subjects in total mus complete the treatment. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. One year. 2. At the treatment session. 3. End of trial after last follow-up (15 Months). |
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E.5.2 | Secondary end point(s) |
1. Pain at rest, coughing and when active Numerical rating score (NRS) for presence of pain before and after treatment and course of pain symptoms. 2. General Health Short form 36 Health Survey on physical, social and mental level of function on a score from 0 to 100. 3. Neuropathic Pain Symptoms Inventory (NPSI) NRS 4. Activities of daily life Impact and intensity of pain categorically in 16 situations of daily life. 5. Patient's Global Impression of Change (PGIC) Rating of global change perceived by the test subject from "More Worse" to "Much better" and a scale from 0 to 10.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Weekly after treatment for 3 months. 2-4 Baseline, 1month and 3 months after treatment. 5. One and 3 months after treatment.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Pilot trial to determine recruitment potential and feasibility of treatment method. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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GCP-Enheden at Aarhus and Aalborg University |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |