Tolerability of Pharmaton PHL 00747 in Healthy, Young Female Subjects of Child-bearing Potential

A 30 Day, Randomised, Double-blind, Double-dummy, Placebo-controlled, Multicentre Safety Trial to Evaluate the Tolerability Profile of Pharmaton PHL 00747 Soft Gelatine Capsules (Multivitamin, Multimineral + Omega-3 Fatty Acids) 1/Day p.o. and Pharmaton PHL 00747 Film-coated Tablets (Multivitamin, Multimineral Without Omega-3 Fatty Acids) 1/Day p.o. in Healthy, Young Female Subjects of Child-bearing Potential

To determine the tolerability and safety of Pharmaton PHL 00747 soft gelatine capsules and film-coated tablets

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Pharmaton PHL 00747 soft gelatine capsules; Dietary supplement: Placebo film-coated tablets (fct); Dietary supplement: Pharmaton PHL 00747 film-coated tablets; Dietary supplement: Placebo soft gelatine capsules

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Healthy female out-patients of child-bearing potential
• Ages ranging between 18 and 40 years
• Willing and able to give written informed consent in accordance to Good Clinical Practice (GCP) and local legislation prior to participation in the study

Exclusion Criteria:

• Contraindications to the use of any of the trial ingredients
• Known hypersensitivity to any of the ingredients
• Alcohol- or drug-addiction
• Currently participation in another trial, or has participated in a trial within the previous 30 days
• Known abnormal values of the laboratory tests (if detected after enrolment, subjects will continue the treatment provided there are no medical objections)
• Already taking other mult-vitamin products during the last 2 weeks

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo film-coated tablets (fct); Dietary supplement: Placebo soft gelatine capsules
Experimental: PHL 00747 capsules	Dietary supplement: Pharmaton PHL 00747 soft gelatine capsules; Dietary supplement: Placebo film-coated tablets (fct)
Experimental: PHL 00747 tablets	Dietary supplement: Pharmaton PHL 00747 film-coated tablets; Dietary supplement: Placebo soft gelatine capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of total drug-related adverse events assessed by the investigator	up to 30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of all adverse events	up to 30 days
Changes from baseline in laboratory tests including Quick's test, activated partial thromboplastin time (aPTT) and cholesterol (total, HDL, LDL)	up to 44 days
Changes from baseline in vital signs (blood pressure and heart rate)	up to 30 days
Overall tolerability assessed by the subject and the investigator on a four-point rating scale	day 30
Overall acceptance of the medications (taste and after taste) by the subject on a four-point rating scale	day 30
Tolerability of the trial medications by the subject	up to 30 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (Actual): March 1, 2004

Study Registration Dates

• First Submitted: July 4, 2014
• First Submitted That Met QC Criteria: July 4, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 4, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 1209.1