Interstitial CystitisPhase 2NCT00739739

An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis

A Phase 2 study testing PD 0299685 at 15mg BID and PD 0299685 at 30mg BID in people with Interstitial Cystitis and Painful Bladder Syndrome, run by Pfizer at 44 sites in 6 countries.

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 determine whether PD 0299685 is effective in the treatment of symptoms associated with interstitial cystitis/painful bladder syndrome, such as pain, urinary urgency and frequency. At the same time assess the drug's safety and tolerability. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Interstitial Cystitis, Painful Bladder Syndrome
What is being tested?: PD 0299685 at 15mg BID and PD 0299685 at 30mg BID
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 161 participants
Where: 44 sitesin 6 countries
Study dates: Aug 2008to Jan 2010
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women over 18 years of age with moderate to severe interstitial cystitis defined by pain score.
Women must not be pregnant or lactating, They may be post-menopausal, surgically sterilized or using an appropriate method of contraception.

Who cannot join

History of interstitial cystitis less than 6 months
History of current or recurrent urinary tract infections, or genitourinary cancer
Any previous urinary diversion procedure with or without bladder removal, bladder augmentation
Use of certain drugs given into the bladder up to 1 month prior to study entry

Trial locations and contacts

44 sites in 6 countries.

Country

City, postcode or hospital

44 sites in 6 countries

United States23 sites

Pfizer Investigational Site
Bethany, Oklahoma, 73008
Pfizer Investigational Site
Brighton, Massachusetts, 02135
Pfizer Investigational Site
Burlington, North Carolina, 27215
Pfizer Investigational Site
Charleston, South Carolina, 29425
Pfizer Investigational Site
Cincinnati, Ohio, 45212
Pfizer Investigational Site
Farmington, Connecticut, 06032
Pfizer Investigational Site
Garden City, New York, 11530
Pfizer Investigational Site
Glendora, California, 91741
Pfizer Investigational Site
Goodyear, Arizona, 85395
Pfizer Investigational Site
Jeffersonville, Indiana, 47130
Pfizer Investigational Site
Litchfield Park, Arizona, 85340
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464
Pfizer Investigational Site
Nashville, Tennessee, 37232
Pfizer Investigational Site
Orlando, Florida, 32804
Pfizer Investigational Site
Phoenix, Arizona, 85032
Pfizer Investigational Site
Poughkeepsie, New York, 12601
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
Shreveport, Louisiana, 71106
Pfizer Investigational Site
Spokane, Washington, 99208
Pfizer Investigational Site
State College, Pennsylvania, 16801
Pfizer Investigational Site
Watertown, Massachusetts, 02472
Pfizer Investigational Site
West Chester, Ohio, 45069

Other trials in United States

Canada7 sites

Pfizer Investigational Site
Barrie, Ontario, L4M 7G1
Pfizer Investigational Site
Kingston, Ontario, K7L 2V7
Pfizer Investigational Site
Kingston, Ontario, K7L 3J7
Pfizer Investigational Site
Kitchener, Ontario, N2N 2B9
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 5N4
Pfizer Investigational Site
Toronto, Ontario, M6A 3B5
Pfizer Investigational Site
Victoria, British Columbia, V8V 3N1

Other trials in Canada

France6 sites

Pfizer Investigational Site
Lyon, 69437
Pfizer Investigational Site
Nantes, 44093
Pfizer Investigational Site
Nîmes, 30029
Pfizer Investigational Site
Paris, 75020
Pfizer Investigational Site
Rennes, 35033
Pfizer Investigational Site
Strasbourg, 67091

Other trials in France

Finland5 sites

Pfizer Investigational Site
Helsinki, 00290
Pfizer Investigational Site
Kouvola, 45200
Pfizer Investigational Site
OYS, 90029
Pfizer Investigational Site
Seinäjoki, 60220
Pfizer Investigational Site
Tampere, 33521

Other trials in Finland

Germany2 sites

Pfizer Investigational Site
Homburg, 66424
Pfizer Investigational Site
München, 81679

Other trials in Germany

Denmark1 site

Pfizer Investigational Site
Herlev, 2730

Other trials in Denmark

About this study

Official title: A Phase 2, 12 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Proof Of Concept Study Evaluating The Efficacy And Safety Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis/Painful Bladder Syndrome.

Conditions: Interstitial Cystitis, Painful Bladder Syndrome
Being tested: PD 0299685 at 15mg BID, PD 0299685 at 30mg BID, placebo for PD 0299685
Medical subject headings: Cystitis, Interstitial

What participants receive

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

PD 0299685 at 15mg BIDDrug
5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study
PD 0299685 at 30mg BIDDrug
10mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study. Initial 2 week titration period at 15mg BID.
placebo for PD 0299685Drug
Capsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study

Study groups in NCT00739739
Study group	Role	What they receive
PD 0299685 15mg	Experimental	Not described Receives: Drug: PD 0299685 at 15mg BID
PD 0299685 30mg	Experimental	Not described Receives: Drug: PD 0299685 at 30mg BID
Placebo	Placebo comparator	Not described Receives: Drug: placebo for PD 0299685

What is being measured

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

Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score.
Measured: 12 WEEKS
Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS).
Measured: 12 WEEKS

Secondary outcomes (17)

Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes.
Measured: 12 weeks
ICSI at other time points
Measured: 12 weeks
Interstitial Cystitis Problem Index (ICPI)
Measured: 12 weeks
Pelvic pain Urgency Frequency score (PUF)
Measured: 12 weeks
Epworth Sleepiness Scale (ESS)
Measured: 12 Weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: 15 Weeks
Adverse events
Measured: 15 Weeks
Physical examination
Measured: 14 Weeks
Vital signs and weight
Measured: 15 Weeks
ECG
Measured: 14 Weeks
Residual urine volume measurement
Measured: 14 Weeks
Global Response assessment (GRA)
Measured: 12 Weeks
Patient Reported Treatment Impact (PRTI)
Measured: 12 Weeks
Treatment failures
Measured: 12 Weeks
Average and worst daily pain score at other time points as measured by an 11-point NRS.
Measured: 12 Weeks
Sleep disturbance and sexual activity pain.
Measured: 12 Weeks
Clinical laboratory tests
Measured: 14 Weeks

Timeline

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

Aug 2008Jan 2010

First posted22 Aug 2008 (estimated)
Study startAug 2008
Primary completionJan 2010
Study completionJan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Interstitial CystitisStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 161 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00739739
Sponsor's protocol ID: A4291043
Status last verified: Mar 2011
First submitted: 20 Aug 2008
Last updated: 28 Mar 2011
Results posted: No
Data monitoring committee: No

Publications

Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
PubMed 32734597
Nickel JC, Crossland A, Davis E, Haab F, Mills IW, Rovner E, Scholfield D, Crook T. Investigation of a Ca2+ channel alpha2delta ligand for the treatment of interstitial cystitis: results of a randomized, double-blind, placebo controlled phase II trial. J Urol. 2012 Sep;188(3):817-23. doi: 10.1016/j.juro.2012.05.010. Epub 2012 Jul 19.
PubMed 22818144

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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Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome

All Interstitial Cystitis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, 12 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Proof Of Concept Study Evaluating The Efficacy And Safety Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis/Painful Bladder Syndrome.
ClinicalTrials.gov ID: NCT00739739
Acronym / sponsor ID: A4291043
Conditions: Interstitial Cystitis, Painful Bladder Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 161 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 22 Aug 2008 (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.

Study design

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

Arm	Type	Receives
PD 0299685 15mg	Experimental	Drug: PD 0299685 at 15mg BID
PD 0299685 30mg	Experimental	Drug: PD 0299685 at 30mg BID
Placebo	Placebo comparator	Drug: placebo for PD 0299685

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Men and women over 18 years of age with moderate to severe interstitial cystitis defined by pain score.
Women must not be pregnant or lactating, They may be post-menopausal, surgically sterilized or using an appropriate method of contraception.

Key exclusion criteria (4 listed)

History of interstitial cystitis less than 6 months
History of current or recurrent urinary tract infections, or genitourinary cancer
Any previous urinary diversion procedure with or without bladder removal, bladder augmentation
Use of certain drugs given into the bladder up to 1 month prior to study entry

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
PD 0299685 at 15mg BID5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study	Drug	PD 0299685 15mg
PD 0299685 at 30mg BID10mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study. Initial 2 week titration period at 15mg BID.	Drug	PD 0299685 30mg
placebo for PD 0299685Capsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study	Drug	Placebo

Primary outcome

Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score.
Time frame: 12 WEEKS
Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS).
Time frame: 12 WEEKS

17 secondary outcomes

Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes.
Time frame: 12 weeks
ICSI at other time points
Time frame: 12 weeks
Interstitial Cystitis Problem Index (ICPI)
Time frame: 12 weeks
Pelvic pain Urgency Frequency score (PUF)
Time frame: 12 weeks
Epworth Sleepiness Scale (ESS)
Time frame: 12 Weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 15 Weeks
Adverse events
Time frame: 15 Weeks
Physical examination
Time frame: 14 Weeks
Vital signs and weight
Time frame: 15 Weeks
ECG
Time frame: 14 Weeks
Residual urine volume measurement
Time frame: 14 Weeks
Global Response assessment (GRA)
Time frame: 12 Weeks
Patient Reported Treatment Impact (PRTI)
Time frame: 12 Weeks
Treatment failures
Time frame: 12 Weeks
Average and worst daily pain score at other time points as measured by an 11-point NRS.
Time frame: 12 Weeks
Sleep disturbance and sexual activity pain.
Time frame: 12 Weeks
Clinical laboratory tests
Time frame: 14 Weeks

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 28 Mar 2011.
Derived from this study: PubMed 32734597Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
Derived from this study: PubMed 22818144Nickel JC, Crossland A, Davis E, Haab F, Mills IW, Rovner E, Scholfield D, Crook T. Investigation of a Ca2+ channel alpha2delta ligand for the treatment of interstitial cystitis: results of a randomized, double-blind, placebo controlled phase II trial. J Urol. 2012 Sep;188(3):817-23. doi: 10.1016/j.juro.2012.05.010. Epub 2012 Jul 19.

Related trials for Interstitial Cystitis

Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome

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

44 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD 0299685 at 15mg BID and PD 0299685 at 30mg BID in people with Interstitial Cystitis and Painful Bladder Syndrome, run by Pfizer at 44 sites in 6 countries.

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 2 inclusion and 4 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 28 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Canada, France, Finland, Germany and 1 more country. 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 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?

Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score. (time frame: 12 WEEKS). 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?

On the ClinicalTrials.gov record for NCT00739739, which also lists 2 linked publications.

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 28 Mar 2011.