HealthyPhase 1NCT00986401

Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects

A Phase 1 study testing Trospium Chloride (Sanctura XR®) and Metformin hydrochloride (Glucophage®) in people with Healthy, run by Allergan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate the safety and tolerability of trospium chloride (Sanctura XR™) and metformin hydrochloride (Glucophage) when co-administered. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Trospium Chloride (Sanctura XR®) and Metformin hydrochloride (Glucophage®)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Nov 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Weight within +/-30% of ideal body weight for height and frame size
Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 1 months prior to the screening visit).
Willing to abstain from caffeine-containing food and beverages for 24-hours prior to dosing, alcohol-containing food and beverage for 48 hours prior to dosing, and Seville oranges (eg orange marmalade), grapefruit, or grapefruit juice for 7 days prior to the dosing and abstain from all throughout the study.
Willing to abstain from taking medications (with the exception of hormonal contraceptives) and nonprescription medication including vitamins, food supplements, and herbal preparations for 7 days prior to Day-1 of the first treatment period and throughout the study.

Who cannot join

Uncontrolled systemic disease
Known allergy or sensitivity to the study medication(s) (Trospium, Metformin)or its components
Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
History of myasthenia gravis or closed-angle glaucoma.
Considering or scheduled to undergo any surgical procedure during the study.
History of alcohol or substance abuse within 1 year prior to Day-1 of the first treatment period.

Show all 12Show fewer

History of serious mental or physical illness.
Donated in excess of 500 mL of blood in the 30 days prior to the screening visit.
Required treatment with any medications, either prescription or nonprescription (including vitamins, antacids, acid-reducers, food supplements, and herbal preparations, excluding hormonal contraceptives), within 7 days prior to Day-1 of the first treatment period during the study.
Had an acute illness within 5 days prior to Day-1 of the treatment period.
Had a history of hepatitis B or C, a positive test for hepatitis B surface antigen, hepatitis C antibody, a history of human immunodeficiency virus (HIV) infection or demonstration of HIV antibodies.
Planned radiologic study requiring intravenous contrast administration of iodinated contrast material during the study period Serum Creatinine greater than 1.4 mg/dL.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Tempe, Arizona

Other trials in United States

About this study

Official title: Safety and Tolerability of Trospium Chloride Metformin Hydrochloride in Healthy Subjects

The purpose of this study is to investigate the safety and tolerability of trospium chloride (Sanctura XR™) and metformin hydrochloride (Glucophage) when co-administered.

Conditions: Healthy
Being tested: Trospium Chloride (Sanctura XR®), Metformin hydrochloride (Glucophage®)
Keywords: Adults

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trospium Chloride (Sanctura XR®)Drug
Also called Sanctura XR® 60 mg
extended release, 60 mg, oral daily
Metformin hydrochloride (Glucophage®)Drug
Also called Glucophage®
immediate release, 500mg

Study groups in NCT00986401
Study group	Role	What they receive
Glucophage® then Sanctura XR® (AB)	Experimental	Treatment Period 1: Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD) for 4 days + Glucophage® (500 mg, BID) for 3.5 days. Receives: Drug: Metformin hydrochloride (Glucophage®)
Sanctura XR® then Glucophage® (BA)	Experimental	Treatment Period 1: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD for 4 days) + Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Glucophage® (500 mg, BID) for 3.5 days. Receives: Drug: Trospium Chloride (Sanctura XR®)

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage®
Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) following oral administration of Glucophage® alone and in combination with SanturaXR®. Plasma is the fluid portion of the blood.
Measured: 34 Days

Secondary outcomes (1)

Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR®
Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR® alone and in combination with Glucophage®. Plasma is the fluid portion of the blood in which the cells are suspended.
Measured: 34 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Nov 2009

First posted30 Sep 2009 (estimated)
Study startOct 2009
Primary completionNov 2009
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
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 1
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00986401
Sponsor's protocol ID: MA-SXR-09-002
Status last verified: Nov 2011
First submitted: 16 Sep 2009
Last updated: 19 Dec 2011
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Tolerability of Trospium Chloride Metformin Hydrochloride in Healthy Subjects
ClinicalTrials.gov ID: NCT00986401
Acronym / sponsor ID: MA-SXR-09-002
Conditions: Healthy
Keywords: Adults
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Nov 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 30 Sep 2009 (estimated)
Results: Posted 19 Dec 2011

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 study is to investigate the safety and tolerability of trospium chloride (Sanctura XR™) and metformin hydrochloride (Glucophage) when co-administered.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Glucophage® then Sanctura XR® (AB)	Experimental	Drug: Metformin hydrochloride (Glucophage®)Treatment Period 1: Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD) for 4 days + Glucophage® (500 mg, BID) for 3.5 days.
Sanctura XR® then Glucophage® (BA)	Experimental	Drug: Trospium Chloride (Sanctura XR®)Treatment Period 1: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD for 4 days) + Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Glucophage® (500 mg, BID) for 3.5 days.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Weight within +/-30% of ideal body weight for height and frame size
Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 1 months prior to the screening visit).
Willing to abstain from caffeine-containing food and beverages for 24-hours prior to dosing, alcohol-containing food and beverage for 48 hours prior to dosing, and Seville oranges (eg orange marmalade), grapefruit, or grapefruit juice for 7 days prior to the dosing and abstain from all throughout the study.
Willing to abstain from taking medications (with the exception of hormonal contraceptives) and nonprescription medication including vitamins, food supplements, and herbal preparations for 7 days prior to Day-1 of the first treatment period and throughout the study.

Key exclusion criteria (12 listed)

Uncontrolled systemic disease
Known allergy or sensitivity to the study medication(s) (Trospium, Metformin)or its components
Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
History of myasthenia gravis or closed-angle glaucoma.
Considering or scheduled to undergo any surgical procedure during the study.

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
Trospium Chloride (Sanctura XR®)Also: Sanctura XR® 60 mgextended release, 60 mg, oral daily	Drug	Sanctura XR® then Glucophage® (BA)
Metformin hydrochloride (Glucophage®)Also: Glucophage®immediate release, 500mg	Drug	Glucophage® then Sanctura XR® (AB)

Primary outcome

Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage®
Time frame: 34 Days
Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) following oral administration of Glucophage® alone and in combination with SanturaXR®. Plasma is the fluid portion of the blood.

1 secondary outcome

Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR®
Time frame: 34 Days

Results and safety

Results posted to the registry on 19 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Glucophage® Then Sanctura XR® (AB)	22	22
Sanctura XR® Then Glucophage® (BA)	22	21

Primary outcome: Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage®

Time frame: 34 Days. Mean (Standard Deviation). Unit: Nanograms per milliliter (ng/mL)

Measure	Glucophage® n = 43	Glucophage® + Sanctura XR® n = 43
Value	739 (263)	753 (252)

Population analysed: Intent-to-treat, which includes all patients who started the study (randomized). One patient was not included in the analysis due to early discontinuation.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Glucophage®	0 of 43 (0%)	10 of 43 (23.3%)	Not reported
Sanctura XR®	0 of 44 (0%)	3 of 44 (6.8%)	Not reported
Sanctura XR® in Combination With Glucophage®	0 of 44 (0%)	13 of 44 (29.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Medical Director study director

Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Trospium Chloride (Sanctura XR®) and Metformin hydrochloride (Glucophage®) in people with Healthy, run by Allergan at 1 site in United States.

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 4 inclusion and 12 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 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage® (time frame: 34 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00986401.

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 19 Dec 2011.