New clinical trial of anti-NGF antibody

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dshoskes
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New clinical trial of anti-NGF antibody

Post by dshoskes »

We are one of several centers in the United States and Canada participating in this new clinical trial, sponsored by Pfizer:

A Phase 2, 16 Week, Multicenter, Randomized, Double Blind Placebo Controlled, Parallel Group Proof of Concept Study Evaluating the Efficacy and Safety of Tanezumab for the Treatment of Pain Associated with Chronic Abacterial Prostatitis

Study involves a single intravenous injection of a medication which binds to Nerve Growth Factor, a molecule in the blood associated with chronic pain conditions. Patients will have a 50:50 chance of receiving drug or an inactive placebo. All costs of the study are borne by the sponsor (Pfizer) and funds are available to patients to reimburse time and travel.

For more information about enrolling in this study at the Cleveland Clinic, please contact our study coordinator, Donna Prots at (216) 445-7505
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kevin
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Re: New clinical trial of anti-NGF antibody

Post by kevin »

Sounds very interesting!

Link to more information on this trial (including other locations where patients are being recruited) here: http://clinicaltrials.gov/ct2/show/NCT00826514
Started: Spring 2003; high urinary frequency and pain associated with bladder filling; urinary hesitancy; pubic/prostate/perineal discomfort; Helped by: trigger point therapy, Afrin nasal spray, Cymbalta, hydrocodone (small doses), distraction. Makes worse: sex.

Not medical advice. Consult your doctor.
coppertop
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Re: New clinical trial of anti-NGF antibody

Post by coppertop »

Does anyone know if you are in a clinical trial, can you continue with other therapies? (i.e. Stanford/Wise-Anderson Protocol, pain relievers, stretching, etc.)?

Thanks
Age: 40 | Onset Age: 38 | Symptoms: Pain in buttocks & ischial tuberosity/lower psoas especially while sitting. Occasional urethra burning. Diagnosis: CPPS/Pudendal Neuralgia | Helped By: Tramadol/Ultracet, Low dose Valium, Q-Urol, Yoga, Stretching regimen, swimming, relaxation, distraction. | Worsened By: Extended sitting at work or in the car, stress. Current Meds: Low dose valium, tramadol, Q-Urol, Omega III Fish Oil
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Re: New clinical trial of anti-NGF antibody

Post by webslave »

No, I'm pretty sure that would mess up the results.
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dshoskes
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Re: New clinical trial of anti-NGF antibody

Post by dshoskes »

For most trials like this, if you have been on a treatment for a predetermined period (usually at least 3 months) and still have symptoms severe enough to qualify, you can continue on that therapy. You cannot start new therapies during the study and therapies that work the same way as the treatment being studied (eg. an alpha blocker for the Uroxatral study) are also exclusions. But it does vary for each study.
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Re: New clinical trial of anti-NGF antibody

Post by ramana »

Thank you Dr Shoskes for your postings. Can you please help with the following queries?
a) I have been having sub acute thyroditis since June and have been put on prednisone. I wanted to participate in the clinical trial but have been turned down because I need to be off from prednisone for at least 3 months. This is what the front desk told me at the clinic where I was going ot be enrolled. I just wanted to confirm if this is true because in the past 2 years, I have been given incorrect / ambiguous information by the front desk at doctors' office on numerous occasions.
b) Once the trials are completed and are successful, how long does it take for the medicine to become mainstream.
Age:36 | Onset Age: 31 (chronic incomplete evacuation since 29) | Symptoms: Anal fissure (3); Pain in the rectum. Left Testicular pain started in August 2007. Professional PT (5 sessions) in June 2007. Stanford/Wise-Anderson Protocol in July 2007. Back to professional PT from Dec 17 2007 onwards twice a week; Dry needling once a week since March 06 2008. | Helped By: Sleeping; lying down; Thermotex infrared heating pad | Worsened By: Any activity; Medications Lyrica 75 mg* 2, Elavil 10mg Supplements; Cod liver oil ; Natural calm started 02/15; Vitamin B12 started 02/16;Vitamin D 1000U 03//08;Glucosamine+hyaluronic acid+MSM 04/08 Bed ridden since August 2007; Working from bed since Dec 2007 ;Botox done 100 units 04/03/08;RAST for wheat/rye/oats/milk -ve. Dairy free since 04/20/08. Gluten free since 04/25/08;Tried without success so far: Baclofen, PEMF machines, pranic healing reiki ;
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dshoskes
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Re: New clinical trial of anti-NGF antibody

Post by dshoskes »

ramana wrote:Thank you Dr Shoskes for your postings. Can you please help with the following queries?
a) I have been having sub acute thyroditis since June and have been put on prednisone. I wanted to participate in the clinical trial but have been turned down because I need to be off from prednisone for at least 3 months. This is what the front desk told me at the clinic where I was going ot be enrolled. I just wanted to confirm if this is true because in the past 2 years, I have been given incorrect / ambiguous information by the front desk at doctors' office on numerous occasions.
b) Once the trials are completed and are successful, how long does it take for the medicine to become mainstream.
All anti-inflammatory drugs cannot be used during the trial so prednisone is out. If a drug is successful, from phase II trials to FDA approval would take a minimum of 2 years. A newly approved drug could take months to years to become "mainstream" (of course depends how well it works to the alternatives, cost, side effects, etc)
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Re: New clinical trial of anti-NGF antibody

Post by gmccormack »

I have been following this drug since I first heard of the clinical trial on it. It is hailed as the new gold standard for chronic lower back pain (CLBP).

For a phase 2 on IC it showed some significant progress.

http://www.pslgroup.com/dg/245786.htm

There does seem to be some heavy side effects, but I think there is a change happening in the pain mngt world away from opiates. Maybe in the second generation of drugs in this class will have less sides.

This is obviously going to be on the market for knee and back pain long before it gets approved for CPPS. But like most meds used for CPPS, it could be used off label, maybe a pain clinic would facilitate the usage for CPPS, it's intravenous.

Guess we'll have to wait for results on CPPS but the positive IC/bladder pain study and considering I think there is an overlap with IC and CPPS, I am optimistic about this.
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Re: New clinical trial of anti-NGF antibody

Post by gmccormack »

After going on a war path with email and phone calls to study sites I think I got into this study under the IC umbrella. The study is being done by Moldwin in NY. It starts in 8-9 weeks according to the research aide. Again, I am excited for this drug because it an antibody to NGF which plays a significant role in pain.

I let you know how it goes when I go, hopefully I don't get the placebo.
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Re: New clinical trial of anti-NGF antibody

Post by gmccormack »

Well I went yesterday for the screening, Pfizer is going all out for this one. I had a cysto, urodynamics, bladder ultrasound post void, blood drawn, EKG, and I need to fill out an E-Diary each night. I mean that visit alone with the cysto probably cost them $600?

I'm pretty sure I qualified and will start the treatment in 10 days. I'm not sure if its ethical to post results, but maybe I will. I have an 80% chance of getting it and the uro said they are seeing "very positive results" not sure how he knows since its double blind...maybe just a general observation.
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