Clinical Trial Result Information
Title of Study:
Safety evaluation on different discontinuation regimens in patients with generalized anxiety disorder associated with clinical disease
Fast Facts:
| Protocol number: | ML17260 |
| Sponsor: | F.Hoffmann-La Roche Ltd |
| Company division: | Pharmaceutical |
| Product name: | Lexotan |
| Generic name: | bromazepam |
| Phase of development: | IV |
| Therapeutic area, approved indication: | Anxiety Disorders |
| Date of report: | 3/15/2006 |
Clinical study summary:
This trial was prematurely terminated, due to slow recruitment. Clinical trial results, other than key safety statements, have not been posted, due to insufficient data.
Study center(s) :
4 centers in Brazil
Objectives:
Primary: To observe signs and symptoms, and change in the variety of anxiety symptoms and vital signs, arising from the discontinuation of three medication withdrawal regimens. Secondary: to evaluate the efficacy of lexotan in anxiety symptoms associated with concomitant clinical disease
Methodology:
Patients were randomized to one of 3 alternative medication withdrawal regimens
Number of patients (planned/analyzed):
36 patients randomized
Diagnosis and main criteria for inclusion:
Male or female patients, aged 18-65 years of age, with a diagnosis of generalized anxiety disorder made within the past 6 months
Test product, dose and mode of administration or test procedure:
Lexotan (bromazepam) 3mg tablets
Duration of treatment:
8 weeks (planned)
Criteria for evaluation (efficacy, safety):
Efficacy: HAM-A scale, sleep miniquestionnaire. Safety: Evaluation Scale for the Symptoms of Withdrawal of CNS Depressants, proportion of patients exhibiting signs and symptoms or anxiety rebound, adverse events, vital signs, weight.
Statistical methods:
Because of the premature termination of the study, the data were not evaluated.
Summary (efficacy, safety, other results):
There were no deaths during this study, and no serious adverse events considered to be related to treatment.
Conclusions:
No conclusions can be drawn from this study, due to its early termination
