Safety and Tolerability of Pharmaton Capsules in Healthy Volunteers

NCT02181959 | Completed Phase 2

• 1 other identifier: 1114.10
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 (2)

• 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

Study Arms (3)

Pharmaton® with DMAE

EXPERIMENTAL

Drug: Pharmaton® with DMAE

Pharmaton® without DMAE

ACTIVE COMPARATOR

Drug: Pharmaton® without DMAE

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pharmaton® with DMAE DRUG

Pharmaton® with DMAE

Pharmaton® without DMAE DRUG

Pharmaton® without DMAE

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: December 1, 1998
• Primary Completion: April 1, 1999
• Last Updated: July 18, 2014

Record last verified: 2014-07