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

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ClinicalTrials.gov Identifier: NCT02183285
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Pharmaton PHL 00747 soft gelatine capsules Dietary Supplement: Pharmaton PHL 00747 film-coated tablets Dietary Supplement: Placebo film-coated tablets (fct) Dietary Supplement: Placebo soft gelatine capsules Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : November 2003
Actual Primary Completion Date : March 2004

Arm Intervention/treatment
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
Placebo Comparator: Placebo Dietary Supplement: Placebo film-coated tablets (fct)
Dietary Supplement: Placebo soft gelatine capsules



Primary Outcome Measures :
  1. Incidence of total drug-related adverse events assessed by the investigator [ Time Frame: up to 30 days ]

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


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183285     History of Changes
Other Study ID Numbers: 1209.1
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: January 2014