HealthyPhase 2NCT02181959
Safety and Tolerability of Pharmaton Capsules in Healthy Volunteers
A Phase 2 study testing Pharmaton® with DMAE and Pharmaton® without DMAE in people with Healthy, run by Boehringer Ingelheim.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pharmaton® with DMAE and Pharmaton® without DMAE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Dec 1998to Apr 1999
- Phase
- Phase 2
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy man or woman, between 20 to 70 years
- Fit to work
- Volunteers have given informed consent and signed the consent form
Who cannot join
- 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)
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Pharmaton® with DMAE, Pharmaton® without DMAE, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaton® with DMAEDrug
Pharmaton® without DMAEDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Pharmaton® with DMAE | Experimental | Not described Receives: Drug: Pharmaton® with DMAE |
| Pharmaton® without DMAE | Active comparator | Not described Receives: Drug: Pharmaton® without DMAE |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: up to 60 days
Assessment of overall tolerability rate on a 4-point scale
Measured: Day 30 and 60
Secondary outcomes (2)
Number of patients with abnormal changes in laboratory parameters
Measured: Day 0, 30 and 60
Number of patients with abnormal findings in physical examination
Measured: Day 0, 30 and 60
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 startDec 1998
- Primary completionApr 1999
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 138 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
- NCT02181959
- Sponsor's protocol ID
- 1114.10
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of PHARMATON Capsules vs PHARMATON Capsules With DMAE vs Placebo in Healthy Volunteers (A Double-blind, Controlled Multicentre Study)
- ClinicalTrials.gov ID
- NCT02181959
- Acronym / sponsor ID
- 1114.10
- Conditions
- Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 1998
- Primary completion
- Apr 1999 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pharmaton® with DMAE | Experimental | Drug: Pharmaton® with DMAE |
| Pharmaton® without DMAE | Active comparator | Drug: Pharmaton® without DMAE |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy man or woman, between 20 to 70 years
- Fit to work
- Volunteers have given informed consent and signed the consent form
Key exclusion criteria (7 listed)
- 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
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® with DMAE | Drug | Pharmaton® with DMAE |
| Pharmaton® without DMAE | Drug | Pharmaton® without DMAE |
| Placebo | Drug | Placebo |
Primary outcome
Number of patients with adverse events
Time frame: up to 60 days
Assessment of overall tolerability rate on a 4-point scale
Time frame: Day 30 and 60
2 secondary outcomes
Number of patients with abnormal changes in laboratory parameters
Time frame: Day 0, 30 and 60
Number of patients with abnormal findings in physical examination
Time frame: Day 0, 30 and 60
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 18 Jul 2014.
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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 2 study testing Pharmaton® with DMAE and Pharmaton® without DMAE 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 7 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 18 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of patients with adverse events (time frame: up to 60 days). The study lists 2 primary outcomes in all. 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 18 Jul 2014.