Has any one taken Pfizer new IV Drug trial ?

[Donvar]

Hi,
I am contemplating taking trial for new drug ( IV) by Pfizer.
In this trial, they will give you one IV injection and then monitor you for 6 weeks. Has anyone gone for this trial ? Please let me know your success if you have gone through it.
I am not sure this is the correct link ( link for this forum) but it seems the only Pfizer clinical trial as of now.

http://www.clinicaltrials.gov/ct2/show/NCT00601484


PS Moderator : I am not sure if I need to copy this thread to "Industry & Research News " section. Please let me know.

[Christi34]

Hi Donvar. Are you participating in the study or have you heard from anyone that is? Please let me know. Thank you.

[Bessie]

Thanks for posting about this. I just sent them my information and I hope that someone contacts me. I am very interested in trying this.

[kadi]

What's in it? What's the theory on it for helping with IC?

[Briza]

http://www.clinicaltrials.gov/ct2/show/NCT00601484
Here is what it says about the study from the link Donvar provided...unfortunately doesn't give any info on what type of treatment/med is being tested, except that it is given via IV:

An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis

This study is currently recruiting participants.
Verified by Pfizer, June 2008

Sponsored by: Pfizer

Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00601484

Purpose
The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis.



Condition Intervention Phase
Cystitis, Interstitial
Painful Bladder Syndrome
Drug: PF-04383119
Drug: Placebo
Phase II



MedlinePlus related topics: Interstitial Cystitis

U.S. FDA Resources

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Official Title: A Phase 2, 16 Week, Multicenter, Randomized, Double Blind Placebo Controlled, Parallel Group Proof of Concept Study Evaluating the Efficacy and Safety of PF-04383119 for the Treatment of Pain Associated With Interstitial Cystitis


Further study details as provided by Pfizer:


Primary Outcome Measures:
Change in average daily pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]



Secondary Outcome Measures:
Change in Pelvic Pain and Urgency/Frequency (PUF) symptom score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Change in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Global response assessment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Patient-reported treatment impact assessment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Treatment failures [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Biomarkers [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Safety endpoints [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Pharmacokinetic measures [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Change in average daily pain [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Change in micturition variables including frequency, nocturnal frequency, incontinence episode frequency, mean volume voided per micturition, mean interstitial cystitis pain severity, urinary urgency episodes, average sleep disturbance score,.... [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Change in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]


Estimated Enrollment: 64
Study Start Date: March 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)


Arms Assigned Interventions
2: Placebo Comparator Drug: Placebo
placebo IV, single dose
1: Experimental Drug: PF-04383119
PF-04383119 200 mcg/kg IV, single dose



Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Male and female adults at least 18 years of age
Moderate to severe interstitial cystitis, with a mean pain intensity score above a pre-defined level.
Exclusion Criteria:

Less than 6 months since onset of interstitial cystitis symptoms
History of recurrent urinary tract infections, or genito-urinary cancer
History of hepatitis B, C or human immunodeficiency virus (HIV)
Previous treatment with an implanted peripheral nerve stimulator
Use of certain drugs given into the bladder up to 1 month prior to study entry
Contacts and Locations


Please refer to this study by its ClinicalTrials.gov identifier: NCT00601484

Contacts


Contact: Pfizer CT.gov Call Center 1-800-718-1021


Hide Study Locations

Locations


United States, Arizona
Pfizer Investigational Site Not yet recruiting
Peoria, Arizona, United States, 85381

United States, California
Pfizer Investigational Site Recruiting
Fresno, California, United States, 93710

United States, Colorado
Pfizer Investigational Site Recruiting
Boulder, Colorado, United States, 80304

United States, Connecticut
Pfizer Investigational Site Not yet recruiting
Hartford, Connecticut, United States, 06041
Pfizer Investigational Site Recruiting
New London, Connecticut, United States, 06320
Pfizer Investigational Site Recruiting
New Britain, Connecticut, United States, 06052
Pfizer Investigational Site Not yet recruiting
Hartford, Connecticut, United States, 06106
Pfizer Investigational Site Recruiting
Middlebury, Connecticut, United States, 06762

United States, Georgia
Pfizer Investigational Site Recruiting
Atlanta, Georgia, United States, 30308
Pfizer Investigational Site Not yet recruiting
Atlanta, Georgia, United States, 30308

United States, Indiana
Pfizer Investigational Site Recruiting
Jeffersonville, Indiana, United States, 47130

United States, Louisiana
Pfizer Investigational Site Recruiting
Shreveport, Louisiana, United States, 71106

United States, Maryland
Pfizer Investigational Site Recruiting
Owings Mills, Maryland, United States, 21117

United States, Michigan
Pfizer Investigational Site Recruiting
Royal Oak, Michigan, United States, 48073

United States, Nebraska
Pfizer Investigational Site Recruiting
Omaha, Nebraska, United States, 68114

United States, New York
Pfizer Investigational Site Not yet recruiting
Rochester, New York, United States, 14627
Pfizer Investigational Site Not yet recruiting
New Hyde Park, New York, United States, 11040

United States, North Carolina
Pfizer Investigational Site Recruiting
Greensboro, North Carolina, United States, 27403

United States, Ohio
Pfizer Investigational Site Recruiting
Cincinnati, Ohio, United States, 45212

United States, Pennsylvania
Pfizer Investigational Site Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15212

United States, South Carolina
Pfizer Investigational Site Recruiting
Greer, South Carolina, United States, 29650

United States, Texas
Pfizer Investigational Site Recruiting
Houston, Texas, United States, 77024

United States, Washington
Pfizer Investigational Site Recruiting
Spokane, Washington, United States, 99207
Pfizer Investigational Site Not yet recruiting
Mountlake, Washington, United States, 98043


Sponsors and Collaborators


Pfizer


Investigators


Study Director: Pfizer CT.gov Call Center Pfizer

More Information

To obtain contact information for a study center near you, click here.


Responsible Party: Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers: A4091010
First Received: January 15, 2008
Last Updated: June 10, 2008
ClinicalTrials.gov Identifier: NCT00601484
Health Authority: United States: Food and Drug Administration


Study placed in the following topic categories:
Cystitis, Interstitial
Urologic Diseases
Urinary Bladder Diseases
Cystitis
Pain




Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome



ClinicalTrials.gov processed this record on August 29, 2008




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U.S. National Institutes of Health, U.S. Department of Health & Human Services,
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[Donvar]

Hi Donvar. Are you participating in the study or have you heard from anyone that is? Please let me know. Thank you.

Hi Christi , I will be going for this trial later,probably after a couple of months.I will be testing out higher dosages of Atarax and Elavil first. I will let you know if I find anyone going for this trial.

[lngo2007]

Hi,
I am contemplating taking trial for new drug ( IV) by Pfizer.
In this trial, they will give you one IV injection and then monitor you for 6 weeks. Has anyone gone for this trial ? Please let me know your success if you have gone through it.
I am not sure this is the correct link ( link for this forum) but it seems the only Pfizer clinical trial as of now.

http://www.clinicaltrials.gov/ct2/show/NCT00601484


PS Moderator : I am not sure if I need to copy this thread to "Industry & Research News " section. Please let me know.


Did you go through the Pfizer trial yet? I am thinking to try on it but I am not sure how it works. Please share if you had it in the last a couple months. Thanks

[Donvar]

Did you go through the Pfizer trial yet? I am thinking to try on it but I am not sure how it works. Please share if you had it in the last a couple months. Thanks

I haven't gone through it yet. I dont think I will go through it now and trial expires in december.

[jvr]

Hello,

Does anyone know anything more about this study from Pfizer? It looks like it's set to be completed in April? When these studies are in Phase 2, I'm assuming no one will know anything at all until this phase is complete? I'm wondering what this drug being tested even is....

Thanks,
Jill

[Mrs. Peel]

Did anyone else notice Hepatitis/HIV in the inclusion criteria?