HealthyPhase 1NCT00832650

Multiple Dose Study To Investigate The Effects Of Fesoterodine And Solifenacin On Gastrointestinal Transit

A Phase 1 study testing fesoterodine fumarate and solifenacin in people with Healthy, run by Pfizer at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To assess the effect of fesoterodine 8 mg as compared to solifenacin 10 mg on colonic transit. Read more about this study

Who is it for?: Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: fesoterodine fumarate and solifenacin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Apr 2009to Dec 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 55 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy female subjects

Who cannot join

Evidence or history of clinically significant findings at screening

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Investigational Site
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose Study To Investigate The Effects Of 8 Mg Fesoterodine SR Tablets And 10 Mg Solifenacin Tablet On Gastrointestinal Transit In Healthy Female Subjects.

To assess the effect of fesoterodine 8 mg as compared to solifenacin 10 mg on colonic transit.

Conditions: Healthy
Being tested: fesoterodine fumarate, placebo, solifenacin
Keywords: Healthy; Fesoterodine; Solifenacin

What participants receive

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

fesoterodine fumarateDrug
8 mg OD for 14 days
placeboDrug
OD for 14 days
solifenacinDrug
10 mg OD for 14 days

Study groups in NCT00832650
Study group	Role	What they receive
Fesoterodine	Experimental	Tablets Receives: Drug: fesoterodine fumarate
Placebo	Placebo comparator	Tablets Receives: Drug: placebo
Solifenacin	Active comparator	Tablets Receives: Drug: solifenacin

What is being measured

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

Colonic Transit at 24 Hours
Colonic transit: Geometric centre at 24 hours (GC24) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC *1 + % TC *2 + % DC *3 + % RS *4 + % stool * 5 ) divided by 100.
Measured: Day 13 (Day 12 24 hours post-meal)

Secondary outcomes (8)

Proximal Colonic Emptying Time
Estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.
Measured: Day 12 to 14
Colonic Transit at 48 Hours
Colonic transit: Geometric centre at 48 hours (GC48) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC *1 + % TC *2 + % DC *3 + % RS *4 + % stool * 5 ) divided by 100.
Measured: Day 14 (Day 12 48 hours post-meal)
Colonic Filling at 6 Hours
A surrogate marker of small bowel transit time.
Measured: Day 12
Time to Gastric Emptying
Ascending colon emptying t½ was estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.
Measured: Day 12: 2 hours, 4 hours
Mean Number of Stools Per Day
Number of stools passed on each notional day where each visit to the toilet counts as one stool (only) unless nothing is passed. Mean of 3 days.
Measured: Day 11 to 13
Mean Score of Stool Consistency Per Day
Calculated by averaging the values of the stool form given at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (hard lumps) to 7 (watery).
Measured: Day 11 to 13
Average Score of Ease of Passage During Defecation Per Day
Calculated by averaging the values given for the ease of passage at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (Manual disimpaction) to 7 (Incontinent).
Measured: Day 11 to 13
Mean Proportion of Bowel Movements With Satisfaction Per Day
The number of stools with satisfaction of "Yes" divided by the total number of stools passed on each notional day. Mean of 3 days.
Measured: Day 11 to 13

Timeline

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

Apr 2009Dec 2009

First posted30 Jan 2009 (estimated)
Study startApr 2009
Primary completionDec 2009
Study completionDec 2009

Why it stopped: Protocol A0221057 was terminated on December 25, 2009 for futility. There were no safety concerns related to this decision.

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by PfizerThe 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00832650
Sponsor's protocol ID: A0221057
Status last verified: Dec 2010
First submitted: 28 Jan 2009
Last updated: 24 Dec 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bharucha AE, Isowa H, Hiro S, Guan Z. Differential effects of selective and non-selective muscarinic antagonists on gastrointestinal transit and bowel function in healthy women. Neurogastroenterol Motil. 2013 Jan;25(1):e35-43. doi: 10.1111/nmo.12043. Epub 2012 Nov 21.
PubMed 23171069

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 24 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose Study To Investigate The Effects Of 8 Mg Fesoterodine SR Tablets And 10 Mg Solifenacin Tablet On Gastrointestinal Transit In Healthy Female Subjects.
ClinicalTrials.gov ID: NCT00832650
Acronym / sponsor ID: A0221057
Conditions: Healthy
Keywords: Healthy; Fesoterodine; Solifenacin
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Protocol A0221057 was terminated on December 25, 2009 for futility. There were no safety concerns related to this decision.
Enrolment: 60 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 30 Jan 2009 (estimated)
Results: Posted 24 Dec 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To assess the effect of fesoterodine 8 mg as compared to solifenacin 10 mg on colonic transit.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Fesoterodine	Experimental	Drug: fesoterodine fumarateTablets
Placebo	Placebo comparator	Drug: placeboTablets
Solifenacin	Active comparator	Drug: solifenacinTablets

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy female subjects

Key exclusion criteria (1 listed)

Evidence or history of clinically significant findings at screening

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
fesoterodine fumarate8 mg OD for 14 days	Drug	Fesoterodine
placeboOD for 14 days	Drug	Placebo
solifenacin10 mg OD for 14 days	Drug	Solifenacin

Primary outcome

Colonic Transit at 24 Hours
Time frame: Day 13 (Day 12 24 hours post-meal)
Colonic transit: Geometric centre at 24 hours (GC24) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC *1 + % TC *2 + % DC *3 + % RS *4 + % stool * 5 ) divided by 100.

8 secondary outcomes

Proximal Colonic Emptying Time
Time frame: Day 12 to 14
Colonic Transit at 48 Hours
Time frame: Day 14 (Day 12 48 hours post-meal)
Colonic Filling at 6 Hours
Time frame: Day 12
Time to Gastric Emptying
Time frame: Day 12: 2 hours, 4 hours
Mean Number of Stools Per Day
Time frame: Day 11 to 13
Mean Score of Stool Consistency Per Day
Time frame: Day 11 to 13
Average Score of Ease of Passage During Defecation Per Day
Time frame: Day 11 to 13
Mean Proportion of Bowel Movements With Satisfaction Per Day
Time frame: Day 11 to 13

Results and safety

Results posted to the registry on 24 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fesoterodine	25	25
Placebo	12	12
Solifenacin	23	22

Primary outcome: Colonic Transit at 24 Hours

Time frame: Day 13 (Day 12 24 hours post-meal). Mean (Standard Deviation). Unit: counts

Measure	Fesoterodine n = 25	Placebo n = 12	Solifenacin n = 23
Value	1.98 (0.770)	2.51 (1.078)	1.91 (0.515)

Fesoterodine vs Solifenacin: LS Mean difference: 0.051 (95% CI -0.334 to 0.436), ANCOVA

Population analysed: Intent to treat (ITT) included all randomized subjects. Imputation by overall mean for missing data.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 7 days after last dose of study drug. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fesoterodine	0 of 25 (0%)	22 of 25 (88%)	Not reported
Placebo	0 of 12 (0%)	6 of 12 (50%)	Not reported
Solifenacin	0 of 22 (0%)	15 of 22 (68.2%)	Not reported

Limitations and caveats (from the sponsor): Study was terminated due to futility based on interim analysis with 60 subjects. Although the results of statistical test for the primary endpoint was interpreted, the other endpoint results were interpreted based on statistical inference.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23171069Bharucha AE, Isowa H, Hiro S, Guan Z. Differential effects of selective and non-selective muscarinic antagonists on gastrointestinal transit and bowel function in healthy women. Neurogastroenterol Motil. 2013 Jan;25(1):e35-43. doi: 10.1111/nmo.12043. Epub 2012 Nov 21.
To obtain contact information for a study center near you, click here.Link 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.

Pfizer CT.gov Call Center study director

Pfizer

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 fesoterodine fumarate and solifenacin in people with Healthy, run by Pfizer 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 24 Dec 2010. 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. 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 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 24 Dec 2010). 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?

Colonic Transit at 24 Hours (time frame: Day 13 (Day 12 24 hours post-meal)). 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 NCT00832650, which also lists 1 linked publication.

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 24 Dec 2010.