Safety and Tolerability of Pharmaton Capsules in Healthy Volunteers

July 17, 2014 updated by: Boehringer Ingelheim

Safety and Tolerability of PHARMATON Capsules vs PHARMATON Capsules With DMAE vs Placebo in Healthy Volunteers (A Double-blind, Controlled Multicentre Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Pharmaton® with DMAE
Drug: Pharmaton® with DMAE
Active Comparator: Pharmaton® without DMAE
Drug: Pharmaton® without DMAE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1998

Primary Completion (Actual)

April 1, 1999

Study Registration Dates

First Submitted

July 2, 2014

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimate)

July 8, 2014

Study Record Updates

Last Update Posted (Estimate)

July 18, 2014

Last Update Submitted That Met QC Criteria

July 17, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 1114.10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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