E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prolonged pain in the neck caused by a whiplash trauma or another muscle injury. |
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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 |
The primary objective of this study is to try the hypothesis if adenosine given intravenously and intermittently, per needed in connection with exacerbations, may decrease spontaneous pain and central sensibilization, while mobility of the neck and the patients´function are increased in patients with prolonged neck pain after a whiplash trauma.
Primary variables: Decrease of spontaneous pain (VAS 0-100) Reduction of pain released by a stimulus Increased mobility in the neck (quantitative measurement) and increased function (neck pain disability index). |
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E.2.2 | Secondary objectives of the trial |
Secondary variables: Duration of decreased spontaneous pain. Duration of improved function. Improvement of sensor variables. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
a) Patients with verified pain in the neck, mainly in soft tissue, where other pharmacotherapy is not enough, due to insufficient effect or side effects. The patients should be diagnosed and have a regular contact with a physiotherapeut specialized in pain. The pain must have a duration of at least six months.
b) The patients should be adenosine responders, i.e. have reacted favourably with decreased pain and subjectively improved function at a minimum of one occasion with open intravenous adenosine treatment, with a qualitative bed status before and after treatment.
c) Age 18-80 years, inclusive.
d) Signed informed consent for participation in the study, including data handling and information about "PUL (Personuppgiftslagen)".
e) The patients are allowed to continue ongoing pharmacotherapy with a stable dosage, but are not allowed to start treatment with a new pain-relieving medicine or change such a dosage during the study period.
f) Pain at rest >=30 on a VAS scale 0 - 100. |
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E.4 | Principal exclusion criteria |
a) Participation in another clinical trial within the last month before inclusion or during the study period.
b) Another severe pain which interferes with the patient´s ability to separate and estimate the neck pain, which is intended to be studied according to the investigator´s assessment.
c) Progressive malign disease.
d) Other conditions which will make participation in the study more difficult, e.g. drug abuse and problems to communicate, according to judgement of the investigator.
e) AV-block II and III without pacemaker treatment.
f) Ongoing treatment with dipyridamol (Persantin). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduction in spontaneous pain >12/100 VAS. Reduction in touch-evoked pain >50%. Neck pain, Disability Index. Improvement in neck movement range. |
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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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.8.3 |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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Last visit of last subject. |
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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 | 6 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |