Phase 2 N=65 Randomized Double-blind Treatment

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

Cystitis, Interstitial

Bottom Line

View on ClinicalTrials.gov: NCT00601484 ↗

Enrolled (actual)

Serious AEs

9.4%

Results posted

May 2021

Primary outcome: Primary: Change From Baseline in Average Daily Pain Score at Week 6 — 6.4; 5.9; -2.3; -1.1 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: PF-04383119 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Apr 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Average Daily Pain Score at Week 6	6.4; 5.9; -2.3; -1.1	—
SECONDARY Change From Baseline in Average Daily Pain Score at Week 2, 4, 10 and 16	-1.5; -0.9; -2.1; -1.0; -2.2; -1.4	—
SECONDARY Percent Change From Baseline in Average Daily Pain Score at Week 2, 4, 6, 10 and 16	-23.2; -15.9; -33.3; -17.1; -36.3; -18.3	—
SECONDARY Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	13.8; 13.2; -2.8; -2.1; -3.2; -1.9	—
SECONDARY Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 2, 4, 6, 10 and 16	-21.0; -16.3; -23.2; -14.5; -20.5; -9.3	—
SECONDARY Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	14.2; 13.0; -1.1; -1.0; -0.8; -0.5	—
SECONDARY Percent Change From Baseline in Number of Micturitions Per 24 Hours at Week 2, 4, 6, 10 and 16	-9.8; -7.4; -8.5; -0.1; -8.9; -8.9	—
SECONDARY Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	7.1; 5.8; -1.5; -0.6; -1.6; -1.5	—
SECONDARY Percent Change From Baseline in Number of Nocturnal Micturitions Per Night at Week 2, 4, 6, 10 and 16	-8.8; -14.6; -12.5; -41.4; -17.7; -29.2	—
SECONDARY Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	0.7; 1.0; -1.4; -2.0; -1.6; -2.1	—
SECONDARY Percent Change From Baseline in Number of Incontinence Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	-97.3; -87.6; -82.5; -68.6; -100.0; -70.3	—
SECONDARY Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	149.9; 172.2; 5.4; 1.4; 2.0; 2.6	—
SECONDARY Percent Change From Baseline in Mean Voided Volume Per Micturition at Week 2, 4, 6, 10 and 16	3.8; -0.1; 0.3; -0.8; -2.8; -2.3	—
SECONDARY Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	5.4; 4.7; -1.4; -0.5; -1.7; -0.4	—
SECONDARY Percent Change From Baseline in Mean Interstitial Cystitis Pain Severity Per Urinary Event at Week 2, 4, 6, 10 and 16	-26.2; -13.1; -32.5; -8.2; -29.9; -5.2	—
SECONDARY Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	8.5; 8.7; -1.7; -0.4; -1.8; 0.1	—
SECONDARY Percent Change From Baseline in Urinary Urgency Episodes Per 24 Hours at Week 2, 4, 6, 10 and 16	-21.5; -4.7; -22.9; 0.8; -30.4; -1.6	—
SECONDARY Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	2.3; 2.1; -0.5; -0.3; -0.7; -0.3	—
SECONDARY Percent Change From Baseline in Average Sleep Disturbance Score Per 24 Hours at Week 2, 4, 6, 10 and 16	-23.7; -11.6; -32.0; -15.5; -33.8; -17.4	—
SECONDARY Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	2.1; 1.4; -0.7; -0.0; -0.7; -0.4	—
SECONDARY Percent Change From Baseline in Average Pain Score Associated With Sexual Activity Per 24 Hours at Week 2, 4, 6, 10 and 16	-28.5; -8.0; -35.4; -38.6; -31.6; -9.3	—
SECONDARY Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Total Score at Week 2, 4, 6, 10 and 16	22.8; 21.1; -4.0; -3.3; -4.4; -3.0	—
SECONDARY Percent Change From Baseline in Pelvic Pain and Urgency/Frequency (PUF) Symptom Total Score at Week 2, 4, 6, 10 and 16	-17.0; -15.6; -18.9; -14.9; -21.4; -18.5	—
SECONDARY Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score at Week 2, 4, 6, 10 and 16	12.3; 11.7; -3.1; -1.8; -3.3; -2.1	—
SECONDARY Percent Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score Week 2, 4, 6, 10 and 16	-26.0; -14.6; -27.2; -18.3; -26.4; -18.6	—
SECONDARY Number of Participants With Global Response Assessment (GRA) at Weeks 6, and 16	0; 1; 1; 0; 2; 3	—
SECONDARY Patient's Global Satisfaction Assessment	5; 0; 7; 6; 7; 4	—
SECONDARY Patient's Global Preference Assessment at Weeks 6, and 16	10; 5; 6; 1; 1; 0	—
SECONDARY Patient Willingness to Re-use Medicine Assessment	9; 3; 5; 5; 9; 3	—
SECONDARY Percentage of Participants Who Use Rescue Medication	48.4; 46.4	—
SECONDARY Ratio of Number of Days Rescue Medication Used	0.00; 0.00	—
SECONDARY Average Number of Doses Per Day of Rescue Medication Used	0.00; 0.00	—
SECONDARY Amount of Rescue Medication Taken Per Day	0.00; 0.00	—
SECONDARY Time to First Dose of Rescue Medication as a Proportion of Total Days in Study	0.00; 0.00	—
SECONDARY Plasma and Urine Total Nerve Growth Factor (NGF) Concentration	16.47; 16.70; 1943.45; 17.13; 2654.76; 17.34	—
SECONDARY Heparin-binding Epidermal Growth Factor-like Growth Factor (HB-EGF) Urine Concentration	108.70; 114.05; 126.08; 109.48; 123.59; 120.09	—
SECONDARY Anti-Proliferative Factor (APF) Urine Concentration	141.40; 157.87; 157.66; 156.96; 146.25; 163.80	—
SECONDARY Number of Participants With Clinically Significant Change From Baseline in Physical Examination	0; 0	—
SECONDARY Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0; 0	—
SECONDARY Number of Participants With Clinically Significant Change From Baseline in Body Weight	0; 0	—
SECONDARY Number of Participants With Clinically Significant Change From Baseline in Neurologic Examination	3; 2	—
SECONDARY Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)	0; 0; 0; 0; 4; 2	—
SECONDARY Post-void Residual (PVR) Volume	28.8; 40.2; 25.9; 33.5; 34.4; 38.6	—
SECONDARY Number of Participants With Laboratory Abnormalities	23; 18	—
SECONDARY Number of Participants With Presence of Anti-Drug Antibody (ADA)	0; 0; 0; 0	—
SECONDARY Plasma Concentration of Tanezumab	82.25; 6070.81; 5520.63; 1885.34; 1214.59; 888.70	—

Summary

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

Eligibility 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 genitourinary cancer;
History of hepatitis B, C or human immunodeficiency virus (HIV);
Use of certain drugs given into the bladder up to 1 month prior to study entry.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00601484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.