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Monoclonal Antibodies

Group 3 for Interstitial Cystitis

Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Awards & highlights

Summary

This trial is testing whether tanezumab is effective at reducing pain associated with IC/PBS, and assessing the drug's safety at different dose levels.

Eligible Conditions
  • Interstitial Cystitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Mean Average Daily Pain Score at Week 8
Secondary study objectives
Amount of Rescue Medication Taken Per Week
Brief Pain Inventory-Short Form (BPI-sf) Score
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
+19 more
Other study objectives
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Number of Participants With Anti-Drug Antibody (ADA)
+6 more

Side effects data

From 2021 Phase 3 trial • 156 Patients • NCT02609828
15%
Arthralgia
15%
Oral candidiasis
14%
Anaemia
14%
Decreased appetite
13%
Oedema peripheral
13%
Prostate cancer
10%
Asthenia
10%
Breast cancer
8%
Fatigue
8%
Pain
8%
Constipation
8%
Diarrhoea
7%
Fall
7%
Headache
7%
Insomnia
6%
Vomiting
6%
Lung neoplasm malignant
6%
Nausea
6%
Influenza like illness
6%
Nasopharyngitis
6%
Pneumonia
4%
Dizziness
4%
Pain in extremity
4%
Weight decreased
4%
Pathological fracture
4%
Metastases to bone
4%
Dyspnoea
3%
Abdominal pain
3%
Urinary retention
3%
Pruritus
3%
Deep vein thrombosis
3%
Neuralgia
3%
Depressed mood
3%
Pyrexia
3%
Paraparesis
3%
Cough
3%
Pulmonary embolism
3%
Peripheral swelling
3%
Osteoarthritis
3%
Leukopenia
3%
Bacterial infection
3%
Bronchitis
3%
Dehydration
3%
Cancer pain
3%
Colon cancer
3%
Paraesthesia
3%
Somnolence
3%
Depression
3%
Haematuria
3%
Bronchitis chronic
3%
Decubitus ulcer
3%
Hypertension
3%
Pallor
1%
Dyspepsia
1%
Haemorrhoids
1%
Jaundice
1%
Oral fungal infection
1%
Respiratory tract infection
1%
Ligament sprain
1%
Hypoalbuminaemia
1%
Hypokalaemia
1%
Mineral deficiency
1%
Muscle spasms
1%
Osteonecrosis of jaw
1%
Colorectal cancer
1%
Paraneoplastic syndrome
1%
Plasma cell myeloma
1%
Hyposomnia
1%
Calculus urinary
1%
Hypertonic bladder
1%
Alopecia
1%
Hyperhidrosis
1%
Onycholysis
1%
Skin ulcer
1%
Urinary tract infection
1%
Loose tooth
1%
Upper respiratory tract infection
1%
Viral infection
1%
Contusion
1%
Cachexia
1%
Metastases to central nervous system
1%
Dysgeusia
1%
Hypoaesthesia
1%
Dermatitis allergic
1%
Malignant neoplasm progression
1%
Arrhythmia
1%
Hypoacusis
1%
Iron deficiency anaemia
1%
Coagulopathy
1%
Vertigo
1%
Keratitis
1%
Cardio-respiratory arrest
1%
Tinnitus
1%
Vision blurred
1%
Abdominal discomfort
1%
Dry mouth
1%
Gastrointestinal haemorrhage
1%
Gastrooesophageal reflux disease
1%
Stomatitis
1%
Inflammation
1%
Allergy to plants
1%
Body tinea
1%
Conjunctivitis
1%
Gingivitis
1%
Herpes zoster
1%
Infection
1%
Onychomycosis
1%
Postoperative wound infection
1%
Sepsis
1%
Nerve injury
1%
Radius fracture
1%
Rib fracture
1%
Skin abrasion
1%
Blood creatinine increased
1%
Body temperature increased
1%
Haematology test abnormal
1%
Platelet count decreased
1%
Diabetic metabolic decompensation
1%
Hypophagia
1%
Arthritis
1%
Back pain
1%
Bone pain
1%
Bursitis
1%
Chondrocalcinosis
1%
Intervertebral disc protrusion
1%
Joint stiffness
1%
Spinal pain
1%
Thoracic spinal stenosis
1%
Breast cancer metastatic
1%
Gastric cancer
1%
Metastases to liver
1%
Metastases to ovary
1%
Pancreatic carcinoma
1%
Pancreatic neoplasm
1%
Tumour pain
1%
Uterine cancer
1%
Burning sensation
1%
Cerebrovascular insufficiency
1%
Epilepsy
1%
Loss of consciousness
1%
Polyneuropathy
1%
Presyncope
1%
Sensory disturbance
1%
Syncope
1%
Tremor
1%
Adjustment disorder with depressed mood
1%
Nervousness
1%
Micturition disorder
1%
Urinary tract obstruction
1%
Oedema genital
1%
Pleurisy
1%
Rash
1%
Scab
1%
Hot flush
1%
Orthostatic hypotension
1%
Peripheral ischaemia
1%
Post thrombotic syndrome
1%
Vascular fragility
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tanezumab 20 mg
Placebo
Tanezumab 10 mg
Tanezumab 10/20 mg

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 4Experimental Treatment1 Intervention
Group II: Group 3Experimental Treatment1 Intervention
Group III: Group 2Experimental Treatment1 Intervention
Group IV: Group 1Experimental Treatment1 Intervention
Group V: Group 5Placebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tanezumab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,638 Previous Clinical Trials
17,738,617 Total Patients Enrolled
1 Trials studying Interstitial Cystitis
161 Patients Enrolled for Interstitial Cystitis
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,527 Previous Clinical Trials
14,910,750 Total Patients Enrolled
1 Trials studying Interstitial Cystitis
161 Patients Enrolled for Interstitial Cystitis
~13 spots leftby Oct 2025
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