E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Generalized Anxiety Disorder | |
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 | Main objective : •To evaluate under open-label conditions the long-term safety and tolerability of pregabalin in doses ranging from 150 to 600 mg/day. | |
E.2.2 | Secondary objectives of the trial | •To enable patients who have participated in pregabalin efficacy studies in anxiety disorders to continue receiving pregabalin treatment on ethical grounds; •To evaluate under open-label conditions the effect of pregabalin on the severity of illness, following either continuation of pregabalin treatment or after switching from an active comparator or placebo in the previous efficacy study | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria | Patients may enroll from short-term efficacy studies of pregabalin in GAD (1008-087 or -152), social phobia (1008-081), or panic disorder (1008-091). Patients enrolling from these prior short-term efficacy studies must: •Have completed the double-blind portion of the preceding trial and completed any protocol specified withdrawal phase and follow-up visits; •If female of childbearing age or potential, continue to use adequate birth control methods and have a negative serum pregnancy test at the preceding double-blind protocol termination or follow-up visit; •Be able to follow the investigator’s instructions and be able to comply with the visit schedule and visit requirements; and •Sign a written informed consent. | |
E.4 | Principal exclusion criteria | Patients may not participate in this study if: •They experienced a serious adverse event or a nonserious, but medically significant adverse event during the preceding efficacy study that was judged to be related to the study medication by the Investigator or the Parke-Davis Medical Monitor; or •They have an ongoing, unresolved, clinically significant medical problem that in the judgment of the investigator or the sponsor would make it unsafe for the patient to participate in the trial. | |
E.5 End points |
E.5.1 | Primary end point(s) | Clinical Global Impression of Severity score | |
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 | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 | The trial involves single site in the Member State concerned | Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | |
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 | |
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 | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 4 |