Tolerability and Safety of Duloxetine BID in Healthy Fema... | NCT02232542

Studies
Tolerability and Safety of Duloxetine BID in Healthy Female Subjects

NCT02232542

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Sep 5, 2014Estimated

Enrollment

32Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Duloxetine - low dose
Duloxetine - high dose
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2003

Primary Completion Date

Aug 2003Actual

Completion Date

Not provided

First Submitted Date

Sep 4, 2014

First Submission Date that Met QC Criteria

Sep 4, 2014

First Posted Date

Sep 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2014

Last Update Posted Date

Sep 5, 2014Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Label	Type	Intervention Names
Duloxetine - low dose	Experimental	Drug: Duloxetine - low dose
Duloxetine - high dose	Experimental	Drug: Duloxetine - high dose
Placebo	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Duloxetine - low dose	Drug		Duloxetine - low dose
Duloxetine - high dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of tolerability by investigator on a 4-point scale		Up to day 14 after drug administration
Number of subjects with adverse events		Up to day 14 after drug administration
Number of subjects with clinically relevant findings in electrocardiogram (ECG)		Up to day 14 after drug administration
Number of subjects with clinically relevant findings in vital signs	systolic and diastolic blood pressure	Up to day 14 after drug administration
Number of subjects with abnormal changes in laboratory parameters		Up to day 14 after drug administration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy female subjects as determined by results of screening
Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
Age ≥ 40 years
BMI ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion Criteria:

Any finding at any of the medical examinations (including blood pressure, pulse rate and ECG (electrocardiogram)) deviating from normal and of clinical relevance (resting heart rate greater than 100 bpm or tachyarrhythmia)
History of or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders (except thyroid hormones and hormonal replacement therapy)
History of relevant orthostatic hypotension, fainting spells and blackouts
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
Chronic or relevant acute infections
History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator, any bleeding disorder including prolonged or habitual bleeding, other hematologic disease, cerebral bleeding (e.g. after a car accident), commotio cerebri
Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
Use of any drugs that might influence the results of the trial (especially CYP2D6 or CYP1A2 modulating substances) within 2 weeks prior to administration or during the trial
Participation in another trial with an investigational drug within 2 months prior to administration or during trial
Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
Alcohol abuse (> 60 g/day)
Caffeine abuse (> 4 cups/day)
Drug abuse
Blood donation within 1 month prior to administration or during the trial
Excessive physical activities within 10 days prior to administration or during the trial
Any laboratory value outside the clinically accepted reference range
Ineffective contraception

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring