E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neuropathic pain in patients with diabetic peripheral neuropathy |
|
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 |
To assess the efficacy of a well-tolerated oral dose of RGH-896 as an analgesic compared with that of placebo for pain associated with symmetrical, distal, sensory diabetic neuropathy |
|
E.2.2 | Secondary objectives of the trial |
To assess tolerability and safety of escalating and maintenance doses of RGH-896, efficacy compared with that of placebo with respect to the change in quality and intensity of pain, pain relief, sleep disruption and global impression of change by investigator and patient, effect on daily dosage of concomitant paracetamol, effect on allodynia and effect on quality of life, activities of daily living and profile of mood states. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Males or females (18 to 70 years of age), BMI 18-37 kg/m2 with a history of neuropathic pain for a minimum of 3 months, associated with distal symmetrical diabetic neuropathy. The average pain intensity score must be ≥ 4 on a 0-10 overall pain Lickert scale in the week prior to the screening visit and ≥ 40 mm on the pain VAS during the baseline week prior to randomisation. The presence of neuropathy will be confirmed by- -a combined (both feet) score of ≥ 3 on the neuropathy deficit score (vibration, pin prick, hot/cold and ankle reflexes), -elevated vibration perception threshold (> 10V) and -sural sensory nerve action potential amplitude reduced to ≤ 8 μV. |
|
E.4 | Principal exclusion criteria |
Acute medical problems including infections, unstable angina, uncontrolled hypertension (BP >175 mmHg or diastolic BP >100 mmHg measured after 10 minutes supine), or evidence of recent (last 3 months) clinically significant changes on electrocardiogram, retinopathy or renal function. Current foot ulcers.Presence of clinically significant peripheral ischemia with absent pedal pulses and absence of biphasic flow on Doppler. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be the comparison of change from baseline in mean VAS (pain on a visual analogue scale) scores between the last 7 days on RGH-896 with that on placebo. |
|
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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
effect on daily dosage of concomitant paracetamol, effect on allodynia, effect of quality of life |
|
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 | Yes |
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.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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
|
The end of the study is defined as the last follow-up visit (Visit 8) of the last patient completing. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |