Safety and Tolerability of Pharmaton Capsules in Healthy... | NCT02181959

Studies
Safety and Tolerability of Pharmaton Capsules in Healthy Volunteers

NCT02181959

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Jul 18, 2014Estimated

Enrollment

138Actual

Phase

Phase 2

Conditions

Healthy

Interventions

Pharmaton® with DMAE
Pharmaton® without DMAE
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

Jul 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

Dec 1998

Primary Completion Date

Apr 1999Actual

Completion Date

Not provided

First Submitted Date

Jul 2, 2014

First Submission Date that Met QC Criteria

Jul 2, 2014

First Posted Date

Jul 8, 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

Jul 17, 2014

Last Update Posted Date

Jul 18, 2014Estimated

Description Module

Brief Summary

The purpose of this trial was to evaluate the safety and tolerability of a galenic formulation of Pharmaton® capsules containing 2-Dimethylaminoethanol (DMAE) in healthy volunteers.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

138Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Pharmaton® with DMAE	Experimental	Drug: Pharmaton® with DMAE
Pharmaton® without DMAE	Active Comparator	Drug: Pharmaton® without DMAE
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pharmaton® with DMAE	Drug		Pharmaton® with DMAE
Pharmaton® without DMAE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with adverse events		up to 60 days
Assessment of overall tolerability rate on a 4-point scale		Day 30 and 60

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with abnormal changes in laboratory parameters		Day 0, 30 and 60
Number of patients with abnormal findings in physical examination		Day 0, 30 and 60

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy man or woman, between 20 to 70 years
Fit to work
Volunteers have given informed consent and signed the consent form

Exclusion Criteria:

Any serious disorder that might interfere with his/her participation in this study and the evaluation of the safety of the test drug (e.g. renal insufficiency, hepatic dysfunction, cardiovascular disease, disorders of the calcium metabolism, hypervitaminosis A or D, psychic disorder, etc)
Treatment with other drugs that might interfere with the evaluation of the safety of the test drug
Known hypersensitivity to any ingredients of the study drug
Pregnancy, lactation, women of childbearing potential who do not use an established contraceptive
Drug and alcohol abuse
Participation in another trial
Known abnormal values of the laboratory tests (if detected after enrolment, subjects will continue the treatment provided there are no medical objections)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided