HealthyPhase 3NCT02183285
Tolerability of Pharmaton PHL 00747 in Healthy, Young Female Subjects of Child-bearing Potential
A Phase 3 study testing Pharmaton PHL 00747 soft gelatine capsules and Pharmaton PHL 00747 film-coated tablets in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To determine the tolerability and safety of Pharmaton PHL 00747 soft gelatine capsules and film-coated tablets Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pharmaton PHL 00747 soft gelatine capsules and Pharmaton PHL 00747 film-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Mar 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
To determine the tolerability and safety of Pharmaton PHL 00747 soft gelatine capsules and film-coated tablets
- Conditions
- Healthy
- Being tested
- Pharmaton PHL 00747 soft gelatine capsules, Pharmaton PHL 00747 film-coated tablets, Placebo film-coated tablets (fct), Placebo soft gelatine capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaton PHL 00747 soft gelatine capsulesDietary supplement
Pharmaton PHL 00747 film-coated tabletsDietary supplement
Placebo film-coated tablets (fct)Dietary supplement
Placebo soft gelatine capsulesDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| PHL 00747 capsules | Experimental | Not described Receives: Dietary Supplement: Pharmaton PHL 00747 soft gelatine capsules; Dietary Supplement: Placebo film-coated tablets (fct) |
| PHL 00747 tablets | Experimental | Not described Receives: Dietary Supplement: Pharmaton PHL 00747 film-coated tablets; Dietary Supplement: Placebo soft gelatine capsules |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo film-coated tablets (fct); Dietary Supplement: Placebo soft gelatine capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of total drug-related adverse events assessed by the investigator
Measured: up to 30 days
Secondary outcomes (6)
Incidence of all adverse events
Measured: up to 30 days
Changes from baseline in laboratory tests including Quick's test, activated partial thromboplastin time (aPTT) and cholesterol (total, HDL, LDL)
Measured: up to 44 days
Changes from baseline in vital signs (blood pressure and heart rate)
Measured: up to 30 days
Overall tolerability assessed by the subject and the investigator on a four-point rating scale
Measured: day 30
Overall acceptance of the medications (taste and after taste) by the subject on a four-point rating scale
Measured: day 30
Tolerability of the trial medications by the subject
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startNov 2003
- Primary completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183285
- Sponsor's protocol ID
- 1209.1
- Status last verified
- Jan 2014
- First submitted
- 4 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02183285
- Acronym / sponsor ID
- 1209.1
- Conditions
- Healthy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Mar 2004 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the tolerability and safety of Pharmaton PHL 00747 soft gelatine capsules and film-coated tablets
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PHL 00747 capsules | Experimental | Dietary Supplement: Pharmaton PHL 00747 soft gelatine capsules, Dietary Supplement: Placebo film-coated tablets (fct) |
| PHL 00747 tablets | Experimental | Dietary Supplement: Pharmaton PHL 00747 film-coated tablets, Dietary Supplement: Placebo soft gelatine capsules |
| Placebo | Placebo comparator | Dietary Supplement: Placebo film-coated tablets (fct), Dietary Supplement: Placebo soft gelatine capsules |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmaton PHL 00747 soft gelatine capsules | Dietary supplement | PHL 00747 capsules |
| Pharmaton PHL 00747 film-coated tablets | Dietary supplement | PHL 00747 tablets |
| Placebo film-coated tablets (fct) | Dietary supplement | PHL 00747 capsules, Placebo |
| Placebo soft gelatine capsules | Dietary supplement | PHL 00747 tablets, Placebo |
Primary outcome
Incidence of total drug-related adverse events assessed by the investigator
Time frame: up to 30 days
6 secondary outcomes
Incidence of all adverse events
Time frame: up to 30 days
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
Changes from baseline in vital signs (blood pressure and heart rate)
Time frame: up to 30 days
Overall tolerability assessed by the subject and the investigator on a four-point rating scale
Time frame: day 30
Overall acceptance of the medications (taste and after taste) by the subject on a four-point rating scale
Time frame: day 30
Tolerability of the trial medications by the subject
Time frame: up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pharmaton PHL 00747 soft gelatine capsules and Pharmaton PHL 00747 film-coated tablets in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of total drug-related adverse events assessed by the investigator (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014; AzTrials last refreshed its copy on 8 Nov 2026.