A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, 10-WEEK PLACEBO CONTROLLED FIXED DOSE STUDY OF PD 0332334 AND PAROXETINE EVALUATING THE EFFICACY AND SAFETY OF PD 0332334 FOR THE TREATMENT OF GENERALIZED ANXIETY DISORDER

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-000763-42-HU
• Date of registration: 04/06/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017
• Public title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, 10-WEEK PLACEBO CONTROLLED FIXED DOSE STUDY OF PD 0332334 AND PAROXETINE EVALUATING THE EFFICACY AND SAFETY OF PD 0332334 FOR THE TREATMENT OF GENERALIZED ANXIETY DISORDER
• Scientific title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, 10-WEEK PLACEBO CONTROLLED FIXED DOSE STUDY OF PD 0332334 AND PAROXETINE EVALUATING THE EFFICACY AND SAFETY OF PD 0332334 FOR THE TREATMENT OF GENERALIZED ANXIETY DISORDER
• Date of first enrolment: 05/09/2008
• Target sample size: 528
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000763-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Hungary

Key inclusion & exclusion criteria

Inclusion criteria:
1. Diagnosis of GAD (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MINI) for DSM-IV Axis I disorders and other clinical information. Subjects with specific phobia(s) (as defined in DSM-IV) or dysthymic disorder will be allowed in the study.

2. Subjects must have a HAM-A total score not less than 20 at the screening (V1) and randomization (V2) visits. Subjects must also have a Covi Anxiety Scale score of not less than 9 and a Raskin Depression Scale score not less than 7 at the Screening (V1) visit to ensure predominance of anxiety symptoms over depression symptoms.

3. Otherwise healthy men or non-pregnant, non-lactating women (women must be using a hormonal or barrier method of contraception or be postmenopausal or surgically sterilized). Healthy is defined as no other clinically relevant abnormalities identified by a detailed medical history, full physical examination including sitting blood pressure (BP) and heart rate measurement, 12-lead ECG, and clinical laboratory tests.

4. Age 18 to 65 years, inclusive.

5. All women must have negative pregnancy tests at the Screening (V1) and Randomization (V2) visits.

6. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

7. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Subjects with evidence or history of clinically significant medical disorders or drug allergies.

2. Any of the following current (within the past 6 mos - present) DSM-IV Axis I diagnoses: MDD; OCD; Panic disorder; Agoraphobia; PTSD; Anorexia; Bulimia; Caffeine-induced anxiety disorder; Alcohol or substance abuse or dependence unless in full remission for at least 6 months; Social anxiety disorder.

3. Any of the following past or current DSM-IV Axis I diagnoses: Schizophrenia; Psychotic disorder; Delirium; dementia; amnestic/other clinically significant cognitive disorders; Bipolar or schizoaffective disorder; Cyclothymic disorder; Dissociative disorders.

4. Antisocial or borderline personality disorder.

5. Serious suicidal risk per investigator’s judgment.

6. Current use of psychotropic medications that cannot be discontinued 2 weeks prior to randomization. Fluoxetine is prohibited within 5 weeks of randomization. If psychotropics are inadvertently administered during the 2 weeks prior to randomization, the investigator and medical monitor will assess subject’s continued eligibility.

7. Use of drugs, supplements, prescription or nonprescription, or food with psychoactive properties. If the products are inadvertently used during the 2 weeks prior to randomization, the investigator and medical monitor will assess subject’s continued eligibility. If subjects experience significant intolerable anxiety during the final week of the study, the medical monitor may authorize (after discussion with investigator) minimal anxiolytic (e.g. benzodiazepine) medication use.

8. Subjects who have been treated with MAO inhibitors in the 14 days prior to the baseline visit.

9. Regular use of benzodiazepines during the 3 months prior to Screening (for at least 5 out of 7 days per week).

10. Subjects initiating formal psychotherapy (e.g. psychodynamic, cognitive and interpersonal therapy) within 3 month prior to screening who intend to continue formal psychotherapy during the study.

11. Positive drug tests at Screening (V1) or Randomization (V2) visits for: amphetamines, barbiturates, opiates, benzodiazepines, sedatives and hypnotics, cocaine, phencyclidine (PCP), cannabinoids, or other illegal or illicit drugs. An exception to the exclusion for a positive benzodiazepine, opiate, or sedative and hypnotic drug test at the Screening (V1) visit may be granted by the Pfizer medical monitor if written evidence of a valid, current prescription is presented.

12. Any condition possibly affecting drug absorption (eg, gastrectomy).

13. Subjects with a current seizure disorder.

14. Subjects with a history of life-threatening neoplasms within 5 years prior to study entry, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin.

15. Subjects with hypo- or hyperthyroidism, except euthyroid subjects who have been on stable doses of thyroid replacement for 6 months or more.

16. Subjects with any clinically unstable hematological, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or cardiovascular disorder.

17. Subjects with uncontrolled narrow angle glaucoma.

18. Subjects with a known hypersensitivity to paroxetine

19. History of allergy or intolerance to paroxetine.

20. Subjects with a prior history of insufficient response to an adequate trial of paroxetine in treating GAD.

21. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable me

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Generalized Anxiety Disorder (GAD).
MedDRA version: 9.1 Level: LLT Classification code 10018105 Term: Generalized anxiety disorder

Intervention(s)

Product Code: PD-0332334
Pharmaceutical Form: Capsule*
Current Sponsor code: PD-0332334
Other descriptive name: (3S,5R)-3-amino-5-methyloctanoic acid hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Product Code: PD-0332334
Pharmaceutical Form: Capsule*
Current Sponsor code: PD-0332334
Other descriptive name: (3S,5R)-3-amino-5-methyloctanoic acid hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Trade Name: Seroxat
Pharmaceutical Form: Capsule*
INN or Proposed INN: PAROXETINE
CAS Number: 61869-08-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Trade Name: Seroxat
Pharmaceutical Form: Capsule*
INN or Proposed INN: PAROXETINE
CAS Number: 61869-08-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: • To assess the efficacy of PD 0332334 in the treatment of GAD as measured by the change from Baseline in the HAM-A total score at Week 8.

• To assess the safety and tolerability of PD 0332334 in subjects with GAD.

Primary end point(s): Change from Baseline in HAM-A total score at Week 8.

Secondary Objective: • To assess the effects of PD 0332334 on disability associated with GAD.
• To assess the time course of action of PD 0332334 on the symptoms of GAD over the 8-week double-blind treatment period.
• To assess the effect of PD 0332334 on the somatic and psychic symptoms of GAD.
• To assess the effect of PD 0332334 on the patient reported symptom of GAD.
• To assess the Week 1 sustained response with PD 0332334 in the treatment of GAD.
• To assess the effects of PD 0332334 on sleep problems and depressive symptoms in subjects with GAD.
• To assess the efficacy of PD 0332334 in the treatment of GAD as assessed by
clinical and patient global impressions.
• To assess the effect of PD 0332334 on sexual functioning, quality of life enjoyment and satisfaction in subjects with GAD.
• To assess the effects associated with discontinuation of PD 0332334 following
short-term use in subjects with GAD.
• To compare the efficacy of PD 0332334 to paroxetine and paroxetine to placebo.

Secondary ID(s)

A5361020