E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Generalized Anxiety Disorder |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018105 |
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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 evaluate the efficacy of Pregabalin and Venlafaxine XR (extended release) compared to placebo in the treatment of GAD). |
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E.2.2 | Secondary objectives of the trial |
To evaluate onset of activity of pregabalin in comparison to placebo and venlafaxine XR in the treatment of GAD symptoms at day 4 of double-blind treatment and to evaluate, through a subject-rated global scale, the efficacy of pregabalin in decreasing GAD symptoms, on a daily basis during the first week of double blind treatment. To evaluate the effect of pregabalin in the treatment of GAD, on improvement in quality of life, sexual satisfaction, disability, sleep and pain. To evaluate the effect of pregabalin and venlafaxine XR in the treatment of depressive symptoms experienced by non-depressed patients diagnosed with GAD. To evaluate the safety of pregabalin and venlafaxine XR in GAD, including overall tolerability, effects on sexual functioning, discontinuations due to adverse events, and discontinuation-emergent symptoms. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Signed and dated informed consent will be obtained from each subject (only include those able to consent) in accordance with the local regulatory and legal requirements. 2. Ages 18 to 65 years. 3. Male or female outpatient. 4. A primary diagnosis of DSM-IV-TRTM (2000) GAD (for criteria refer to Appendix F of the protocol). GAD will be diagnosed with the MINI International Neuropsychiatric Interview (M.I.N.I) Version 5.0.0. The more detailed Module P GAD from the M.I.N.I. Plus (Version 5.0.0) will be used to assess the GAD diagnosis specifically. 5. Hamilton Anxiety Rating Scale (HAM-A) total score > 20 and a score of > 10 on both the psychic and somatic factor scores at screening and baseline. 6. At least 4 Global Anxiety Visual Analogue Scale assessments must be completed between screening and baseline. 7. At least 4 Daily Pain Rating Scale assessments must be completed between screening and baseline. 8. Screening laboratory values must be within normal limits, or abnormalities must be clinically insignificant. Liver function tests > 2 times the upper limit of normal are considered significant. 9. Females of childbearing potential must have a negative serum b-HCG pregnancy test and be practicing an effective form of contraception (accepted methods are hormonal [oral contraceptive or injectable contraceptive], double barrier with spermicide, or intrauterine device-IUD). Complete abstinence may be considered acceptable, but must first be discussed on a case-by-case basis with the Pfizer monitor prior to any screening tests or procedures for the study. |
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E.4 | Principal exclusion criteria |
1. Pregnant or lactating women. 2. Hamilton Depression Rating Scale (17-item HAM-D) score > 15 or score of > 2 on item 1 (depressed mood) of HAM-D. (Refer to Appendix I of the protocol) 3. A current DSM-IV-TRTM (2000) diagnosis of major depressive disorder, dysthymia, obsessive-compulsive disorder, posttraumatic stress disorder, body dysmorphic disorder or eating disorder at screening or within the past 6 months. 4. DSM-IV-TRTM (2000) diagnosis of substance abuse or dependence within the last 6 months prior to screening. (Refer to Appendix G of the protocol) 5. Mental condition, including mental retardation, rendering the individual unable to understand the nature, scope, and possible consequences of the study and/or evidence of an uncooperative attitude. 6. A current or lifetime diagnosis of schizophrenia, or any other psychotic disorder, or bipolar disorder. 7. A history of a seizure disorder, except febrile seizures of childhood. 8. Creatinine clearance ≤ 60 ml/min (estimated from serum creatinine, body weight, age, and sex using the Cockroft-Gault equation (refer to Appendix E of the protocol)). Subjects who have an estimated creatinine clearance of less than 60 ml/min by this screening method may, at the investigator’s discretion, have their creatinine clearance measured with a 24-hour urine collection, performed at the central laboratory. If this 24-hour urine creatinine clearance is greater than 60 ml/min, the subject may be randomized. 9. Receiving psychotherapy (e.g., cognitive therapy, cognitive-behavioral therapy, supportive therapy or others) in which the specific focus of the therapy is GAD and its symptoms, or another anxiety disorder. Subjects who are contemplating beginning a course of psychotherapy and/or behavioral therapy during the study. Subjects already receiving psychotherapy (unrelated to the treatment of GAD or any other anxiety disorder) for at least 3 months prior to screening may be entered, provided their therapy remains unrelated to the treatment of GAD or other anxiety disorder, and there is no change in the type of therapy, or therapist during the study. 10. Received or have required electroconvulsive therapy within six (6) months prior to study entry. 11. Antidepressant, anxiolytic, antipsychotic, sedative (other than zopiclone or zolpidem for insomnia), hypnotic or psychoactive drug use within 2 weeks (5 weeks for fluoxetine) prior to the baseline visit or during the study. If medication is required for the treatment of insomnia during the one-week wash-out, zopiclone (3.75 mg per night) or zolpidem (5 mg per night) may be taken intermittently (prn) on two or fewer nights until 3 days before baseline. 12. Received depot neuroleptics within the previous 6 months of the baseline visit. 13. All herbal psychoactive treatments within 14 days of the baseline visit. 14. Daily and/or regular use of benzodiazepines at any dose within 4 weeks of the baseline visit. 15. Urine screen positive for benzodiazepines at Screening and/or Baseline Visit. 16. Requiring concomitant therapy with any psychotropic drug or drug with a psychotropic component during the course of the study (If medication is required for the treatment of insomnia during the one-week wash-out, zopiclone (3.75 mg per night) or zolpidem (5 mg per night) may be taken intermittently (prn) on two or fewer nights until 3 days before baseline.). 17. Requiring treatment with medications other than those permitted on the concomitant medication chart (Appendix C of the protocol) at the end of the wash-out, lead-in period. 18. Previously have been treated with venlafaxine IR, venlafaxine XR, or pregabalin (for any disorder).
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy parameter is the Hamilton Anxiety Scale (HAM-A), which is assessed at each study visit. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Yes |
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 undergoing trial |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |