Clinical TrialsClinical TrialsRelated to PainRelated to Pain

Clinical Trials.gov

Overview

This presentation illustrates the types of competitive insights that can be derived by utilizing data downloads from clinicaltrials.gov.

Analyses can be constrained to particular diseases, therapeutic categories1, study designs, phases, location, size of trials (enrollees), duration of trials, location (US or foreign), sub-grouped by industry and non-industry sponsors, etc.

With additional data extraction2 and effort, it is possible to compile lists of principal investigators and compare/contrast primary endpoints.

There are over 72K trials listed1 of which 7.6% are related to pain2!

There are over 72K clinical trial NCT ids listed on the clinicaltrials.gov website.

5,475 of these trials are related to pain.

Both the volume and percent of trials related to pain is increasing annually.

Almost 1/10 trials listed in 2008 related to pain.

Start Date All Trials Pain

Subset Pain %

Total Prior to 90s 510 19 3.7%90's 5,217 185 3.5%2000 1,934 85 4.4%2001 2,422 108 4.5%2002 3,503 240 6.9%2003 4,929 367 7.4%2004 6,469 527 8.1%2005 8,147 640 7.9%2006 9,617 831 8.6%2007 10,460 862 8.2%2008 11,102 1,011 9.1%2009 4,240 388 9.2%2010 26 3 11.5%Not Specified 3,866 209 5.4%Grand Total 72,442 5,475 7.6%

Start Date All Trials Pain

Subset Pain %

Total Prior to 90s 510 19 3.7%90's 5,217 185 3.5%2000 1,934 85 4.4%2001 2,422 108 4.5%2002 3,503 240 6.9%2003 4,929 367 7.4%2004 6,469 527 8.1%2005 8,147 640 7.9%2006 9,617 831 8.6%2007 10,460 862 8.2%2008 11,102 1,011 9.1%2009 4,240 388 9.2%2010 26 3 11.5%Not Specified 3,866 209 5.4%Grand Total 72,442 5,475 7.6%

There are over 72K trials listed1 of which 7.6% are related to pain2!

Over 1/3 of all pain-related trials are currently recruiting patients.

Recruitment Pain Trials % TrialsRecruiting 1,949 35.60%Active, not recruiting 629 11.49%Not yet recruiting 368 6.72%Enrolling by invitation 54 0.99%Available 2 0.04%Open Total 3,002 54.83%Closed 2,473 45.17%Total Pain Trials 5,475 100.00%

Recruitment Pain Trials % TrialsRecruiting 1,949 35.60%Active, not recruiting 629 11.49%Not yet recruiting 368 6.72%Enrolling by invitation 54 0.99%Available 2 0.04%Open Total 3,002 54.83%Closed 2,473 45.17%Total Pain Trials 5,475 100.00%

51% of all pain-related trials are/have been conducted within the USA.

Currently 53% of open pain trials are located in the USA.

Pain Trials Recruitment Status & Location

Foreign Closed, 1266,

23%

Foreign Open, 1408, 26%

USA Closed, 1207, 22%

USA Open, 1594, 29%

Over ½ of all pain-related trials list a drug as the intervention.

Combined, procedures and devices make up 1/4th of the interventions for these pain trials.

11%

51%

14%

9%

54%

17%

10%

52%

15%

0%

20%

40%

60%

80%

100%

USA Foreign Total

Pain Trials Intervention & Location

Procedure

Other

Genetic

Gene Transfer

Drug

Dietary Supplement

Device

Biological

Behavioral

Over 1.9M patients1 have been enrolled for pain-related trials.

One out of five trials are recruiting patients limited to one age cohort (child or adult or senior).

Only 18% of pain-related trials recruit/ed children.

Age Groups Trials Enrollees Trials EnrolleesAdult & Senior 64.2% 62.9% 3,515 1,212,587 Child & Adult & Senior 9.9% 18.9% 544 364,171 Adult 17.5% 13.3% 957 256,393 Child 4.0% 3.0% 221 57,677 Child & Adult 4.2% 1.7% 229 33,008 Senior 0.2% 0.3% 9 5,179 Grand Total 100% 100% 5,475 1,929,015

Percent Counts

Industry has funded1 40% trials and 49% of reported enrollees.

3,275

1,728

472

0

500

1,000

1,500

2,000

2,500

3,000

3,500

Pain Trials

0

500

1,000

1,500

2,000

2,500

3,000

3,500

Trials

Non-Industry Industry Alone Industry Co-Sponsor

980,633

718,082

230,300

0

100,000

200,000

300,000

400,000

500,000

600,000

700,000

800,000

900,000

1,000,000

Enrollees

Pfizer has funded1 more pain related trials than any other manufacturer.

The top 10 manufacturers of pain-related trials are listed above.

Funded By Trials EnrolleesPfizer 68 58,806 AstraZeneca 29 11,982 GSK 27 20,883 Novartis 37 22,922 Eli Lilli & Co 30 19,698 Allergan 18 3,510 Wyeth 18 6,245 Merck 18 49,343 Johnson & Johnson 17 24,493 Sanofi-Aventis 15 30,857

Funded By Trials EnrolleesPfizer 68 58,806 AstraZeneca 29 11,982 GSK 27 20,883 Novartis 37 22,922 Eli Lilli & Co 30 19,698 Allergan 18 3,510 Wyeth 18 6,245 Merck 18 49,343 Johnson & Johnson 17 24,493 Sanofi-Aventis 15 30,857

15% of open trials are listed as Phase IV

The chart below is limited to open trials but includes those trials not yet recruiting.

Phases Open Trials No. Trials No. Enrollees % Trials % EnrolleesNot Specified 1,199 651,811 39.9% 54.7%Phase 0 22 1,819 0.7% 0.2%Phase I 127 8,270 4.2% 0.7%Phase I|Phase II 97 6,783 3.2% 0.6%Phase II 459 57,706 15.3% 4.8%Phase II|Phase III 99 22,615 3.3% 1.9%Phase III 542 291,756 18.1% 24.5%Phase IV 457 150,180 15.2% 12.6%Grand Total 3,002 1,190,940 100.0% 100.0%

Conditions of Phase IV TrialsConditions Trials Conditions Trials Conditions Trials* Myocardial Infarction Angina Pectoris Cerebrovascular Accidents Diabetes Mellitus 1 Angina, Unstable 1 Cancers, Pain 1

Abortion Curettage 1 Ankle Fracture 1 Cardiovascular Disease 1

Achilles Tendinopathy 1 Ankylosing Spondylitis 1 Catheterization 1Active Rheumatoid Arthritis 1 Anxiety 1 Central Pain in Multiple Sclerosis 1

Acute Coronary Syndrome Non ST Segment Elevation Myocardial Infarction Unstable Angina 1 Arm Injuries 1 Cerebral Palsy 1

Acute Hypovolemia 1 Arthralgia 1Cervicobrachial Neuralgia Myofascial Pain Syndromes 1

Acute Pain 2 Arthritis 1 Cesarean Section 1Acute Pain Pain Relief 1 Arthritis, Psoriatic Arthritis, Rheumatoid 1 Cesarean Section Pregnancy 1Acute Pharyngeal Tonsil 1 Arthritis, Rheumatoid Osteoarthritis 1 Chest Pain 1

Acute Respiratory Infection Sinusitis 1Arthroplasty, Replacement, Knee Total Knee Replacement 1 Cholecystolithiasis 1

Acute Respiratory Infections Acute Rhinosinusitis 1 AS Patients 1 Chronic Achilles Tendinopathy 1

Adhesions Cesarean Section Delivery, Obstetric 1 Atrial Fibrillation 2 Chronic Angina 1Adhesive Capsulitis of the Shoulder 1 Atrial Flutter 1 Chronic Low Back Pain 3

Adhesive Capsulitis Post-Operative Pain 1 Awareness During General Anesthesia 1Chronic Low Back Pain Opioid-Induced Hyperalgesia 1

Alzheimer Disease Dementia Dementia, Vascular Pain 1 Back Pain 2 Chronic Pain 2

Amputation, Traumatic Pain Postoperative Pain 1Back Pain Neck Pain Sleep Initiation and Maintenance Disorders 1 Chronic Pain Osteoarthritis 1

Amputation Phantom Limb Pain Stump Pain 1 Benign Prostatic Hyperplasia 1 Chronic Thoracotomy Pain 1

An Unique Vertebral Fracture 1 Benign Prostatic Hyperplasia (BPH) 1Clinical Radiculopathy Myelopathy Due to a Cervical Disk Disease 1

Analgesia 3 Bone Neoplasm 1 Closed Fracture Open Fracture 1Analgesia Pain Systemic Inflammatory Stress Response 1 Bone Neoplasms Pain, Intractable Cancer 1 Cluster Headache 1Analgesic Rebound Headache 1 Brain Injury and Disease 1 Complex Regional Pain Syndrome 1Anesthesia 1 Breast Cancer With Bone Metastasis 1 Conscious Sedation 1

Anesthesia Recovery Period Pain, Postoperative 1 Breast Neoplasms Pain,Postoperative 1 Conscious Sedation Laceration 1Anexiety/Depression in Cardiological Unit 1 Bursitis 1 Constipation Parkinson's Disease 1

Angina Pectoris 2Cancer Spinal Disease Vertebral Compression Fractures 1 Contraception 1

Angina Pectoris, Variant 1 Cancer Spinal Fractures 1Coronary Artery Bypass Surgery Pneumonia Surgical Site Infection 1

Conditions of Phase IV Trials Con’t.Conditions Trials Conditions Trials Conditions TrialsCoronary Artery Disease 1 Dialysis Fistula 1 Hallux Valgus 1Coronary Artery Disease Pain Peripheral Nervous System Diseases Polyneuropathy 1 Distal Radius Fractures 1

Head and Neck Neoplasms Head and Neck Cancer Wounds Ulcer 1

Coronary Atherosclerosis Angina Pectoris Myocardial Infarction 1 Early Breast Cancer 1 Headache 2Coronary Heart Disease Angina Pectoris Atherosclerosis 1

Elective Laproscopic Bilateral Inguinal Hernia Elective Laproscopic Cholecystectomy 1 Headache Epilepsy Dizziness 1

Coronary Restenosis 1 Endometriosis 1 Healthy 4Critical Limb Ischemia Arterial Occlusive Disease Pain Ischemia 1 Endometriosis Chronic Pelvic Pain 1 Healthy Anesthesia 1

Crohn's Disease 1 Epilepsy 1Heart Disease Myocardial Infarction Acute Myocardial Infarction 1

Degenerative Cervical Disc Disease 1Episodic Cluster Headache Chronic Cluster Headache 1 Heel Pain Plantar Fasciitis Plantar Pain 1

Degenerative Disc Disease 1 Episodic Migraine 1 Hemorrhoids 1Degenerative Disc Disease (DDD) Decompresion of Spine Root 1 Epistaxis Nasal Obstruction Pain 1 Hernia, Inguinal 2Degenerative Joint Disease Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis 1 Explicit Recall of Intra-Operative Events 1 Hernia, Inguinal Hernia, Ventral 1

Dehydration 2 Fabry Disease 1Hernia, Ventral Body Image Respiratory Function Tests Quality of Life Laparoscopy 1

Dental Crowding 1 Fast Ventricular Tachycardia 1 Herpes Zoster Postherpetic Neuralgia Pain 1Dental Extraction 1 Fatigue 1 Hip Dysplasia Pain 1Dental Pain Postoperative Pain 1 Fibromyalgia 5 Hip Fracture 2Depression 1 Fibromyalgia, Primary 1 Hip Osteoarthritis 1Depression Bereavement 1 Fibromyalgia Insomnia 1 HIV Infections 1Depression Dementia 1 Fibromyalgia Pain 1 Hyperalgesia 3Depression Pain 1 Flail Chest 1 Incisional Hernia 1

Depressive Disorder 1 Fluid Therapy Morbidity 1Infantile Colic Infantile Functional Gastrointestinal Disorders 1

Depressive Disorder, Major 1 Fracture Fixation Pain, Postoperative 1 Infection 1Depressive Syndrome Anxiety 1 Fracture Pain 1 Infertility Pain 1

Diabetes Mellitus, Type 1 1Functional Dyspepsia Epigastric Pain Syndrome Post Prandial Distress Syndrome 1 Inflammation 1

Diabetic Neuropathies 2 Gallstone 1 Inguinal Hernia Chronic Pain 1

Diabetic Neuropathies Depressive Disorder, Major 1 Gastroesophageal Reflux Disease 1Inguinal Hernia Laparoscopic Surgery Pain Sexual Dysfunction, Physiological 1

Diabetic Neuropathy, Painful 1 Grafting, Bone Tibial Fractures 1 Injuries, Spinal Cord Pain 1

Conditions of Phase IV Trials Con’t.Conditions Trials Conditions Trials Conditions TrialsInterstitial Cystitis 1 Major Depressive Disorder Back Pain Aged 1 Neuropathic Pain Pain 1

Intervertebral Disk Displacement Disk Prolapse 1Major Depressive Disorder Dysthymia Spinal Cord Injuries 1 Neuropathic Pain Postmastectomy Pain 1

Irritable Bowel Syndrome 4 Malaria, Falciparum 1Non-Cardiac Chest Pain Gastroesophageal Reflux Disease 1

Ischemic Heart Disease 1 Malignant Melanoma Carcinoma, Squamous Cell 1 Obstructive Tonsillar Hypertrophy Tonsillitis 1

Joint Disease 1 Marginal Ulcers 1One or Two Traumatic Vertebral Fractures Located Between T11 and L5, Balloon Kyphoplasty 1

Joint Instability 1 Mastectomy Postoperative Pain Complications 1 Operation Time Pain Score Recurrence Survival 1Kidney Disease Muscle Weakness Pain Fractures, Bone 1

Memory Disorders, Age-Related Retention Disorders, Cognitive 1 Opiate Addiction 1

Knee Osteoarthritis 4 Metastatic Epidural Spinal Cord Compression 1 Opiate Addiction Refractory Pain 1Labor Pain 2 Migraine 4 Opioid-Induced Constipation (OIC) 2Labor Pain Pregnancy Loss Labor Induction 1 Migraine Disorders 1 Orthodontic Pain 1Labor Pain 1 Migraine Headache 1 Osteoarthritis 12

Laparoscopic Cholecystectomy 1Migraine Headaches Migraine With or Without Aura Migraine, Acute 1 Osteoarthritis of the Knee 4

Leg Length Inequality Foot Deformities 1Migraine Tension-Type Headache Primary Headache Disorder 1 Osteoarthritis, Knee 6

Leiomyoma Uterine Fibroids Uterine Neoplasms Menorrhagia Leiomyomatosis 1 Multiple Sclerosis 1

Osteoarthritis Avascular Necrosis Rheumatoid Arthritis 1

Leukemia Non Hodgkin Lymphoma 1 Muscle Spasticity 1 Osteoarthritis Back Pain 1Liver Transplantation 1 Myocardial Infarction Arthritis 1 Osteoarthritis Gonarthritis 1

Low Back Pain 6Myocardial Infarction Unstable Angina Pectoris Diabetes Mellitus Impaired Glucose Tolerance 1 Osteoarthritis Pain 1

Low Back Pain Depression 2 Nasal Surgery 1Osteoarthritis Rheumatoid Arthritis Post-Traumatic Arthritis 1

Low Back Pain Recurrent Lumbar Disc Herniation 1 Nausea and Vomiting, Postoperative 1 Osteoarthrosis 1Low Back Pain Spondylolisthesis Spinal Stenosis Intervertebral Disc Displacement 1 Nephrectomy Laparoscopic Donor Nephrectomy 1

Osteogenesis Imperfecta Osteoporosis Paget Disease of Bone 1

Low Birth Weight Infant Enteral Nutrition 1 Nephrolithiasis 1 Osteonecrosis 1

Lumbar Spinal Stenosis 1 Neurogenic Intermittent Claudication 1Osteopenia Osteoporosis Multiple Myeloma Bone Neoplasms 1

Major Depression 1Neurogenic Intermittent Claudication Lumbar Spinal Stenosis 1 Osteoporosis 1

Major Depression Diabetes Mellitus 1 Neuropathic Pain 1Osteoporotic Vertebral Fracture Between T5 and L5 Older Than 6 Weeks 1

Major Depression Pain Abdominal Pain 1 Neuropathic Pain Rebel 1 Pain 27

Major Depressive Disorder 2 Neuropathic Pain Multiple Sclerosis 1Pain Management Function Minimally Invasive Total Knee Arthroplasty Celecoxib 1

Conditions of Phase IV Trials Con’t.Condition Trials Condition Trials Condition Trials

Pain Management Spinal Fusion Scoliosis 1 Plantar Fasciitis 1Prosthesis-Related Infections Staphylococcal Infections 1

Pain Measurement 1 Post Operative Analgesia 1 Pudendal Neuralgia Canal Syndrome 1

Pain, Postoperative 6 Post Operative Pain Total Knee Replacement 1 Radicular Pain Secondary to Focal Disc Protrusion 1Pain, Postoperative Postoperative Nausea and Vomiting 1 Post Traumatic Headache 1 Refractive Surgical Procedures 1Pain, Postoperative Postoperative Nausea and Vomiting Cesarean Section 1 Post-Operational Pain 1 Renal Cell Cancer Neoplasm Metastasis 1Pain Breast Cancer 1 Postoperative Analgesia 1 Rheumatoid Arthritis 3

Pain Depression 1Postoperative Delirium (PD) Postoperative Cognitive Dysfunction (POCD) 1 Rheumatoid Arthritis Arthritis 1

Pain Fever Hepatotoxicity 1 Postoperative Nausea and Vomiting (PONV) 1 Rheumatoid Arthritis Inflammation 1

Pain Low Back Pain Leg Pain 1 Postoperative Pain 7

Rheumatoid Arthritis Osteoarthritis Post-Traumatic Arthritis Collagen Disorders Avascular Necrosis Traumatic Femoral Fractures Nonunion of Femoral Fractures Congenital Hip Dysplasia Slipped Capital Femoral Epiphysis 1

Pain Mucositis 1 Post-Operative Pain 1 Rib Fracture 1Pain Neoplasm Metastasis Cancer 1 Postoperative Pain Foot Numbness 1 Rib Fractures 1Pain Unspecified Adult Solid Tumor, Protocol Specific 1 Postoperative Pain Hip Arthroplasty 1 Rotator Cuff Tear 1

Painful Bladder Syndrome Interstitial Cystitis 1 Postoperative Pain Inflammation 1Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint. 1

Painful Polyneuropathy 1 Postoperative Pain Opioid Use 1 Sciatica Lumbar Degenerative Disc Disease 1Painful Shoulder Osteoarthritis 1 Post-Operative Pain Pre-Operative Anxiety 1 Scoliosis 1

Pancreatic Cancer 1Postoperative Pain Thyroidectomy Cyclooxygenase 2 Inhibitors 1 Second Degree Burn 1

Parkinson Disease 1Post-Tonsillectomy Pain Post-Tonsillectomy Activity Post-Tonsillectomy Hydration 1 Sedation Oxidative Stress 1

Partial Meniscectomy Chondral Lesions 1Post-Traumatic Headache Head Trauma,Closed Retention Disorders,Cognitive 1 Severe Spasticity Chronic Pain 1

Patients Suitable for THA 1 Pregnancy Pain 1 Severe, Acute Pain in a Pre-Hospital Setting 1Percutaneous Coronary Intervention 1 Pregnancy Parturition 1 Shock 1Percutaneous Nephrolithotomy Kidney Stones 1 Premature Birth 1 Shoulder Orthopedic Surgery Nerve Block 1Peripheral Arterial Disease 2 Prematurity 1 Sickle Cell Disease 2Peripheral Arterial Occlusive Disease 2 Primary Insomnia 2 Sinusitis 2Peripheral Artery Disease 1 Procedural Sedation 1 Skin Diseases, Infectious Soft Tissue Infections 1Peritoneal Dialysis 1 Prostate Cancer With Bone Metastasis 1 Sleep Initiation and Maintenance Disorders 1Planned Abdominal Hysterectomy 1 Prostate Cancer Breast Cancer Bone Metastasis 1 Spasmodic Torticollis 2

Conditions of Phase IV Trials Con’t.Condition Trials Condition TrialsSpinal Fractures Fractures, Compression 1 Upper-Extremity Surgery Post-Operative Pain 1Sprains and Strains Contusions 1 Ureteral Calculi, Hyperalgic, Not Complicated 1Stable Angina Pectoris Percutaneous Coronary Intervention 1 Urinary Incontinence 1Sternal Wound Infection Mediastinitis 1 Urinary Incontinence, Stress 1

Sternal Wound Infection Sternal Non-Union Pain Mediastinitis 1

Urinary Tract Infection (Urinary Burning, Urgency, Pollakiuria, Dysuria, Pyuria, Lumbar or Pelvic Pain), A Temperature> 38 -¦ C, Positive ECBU Direct Seed Sensitive to the Fluoroquinolones 1

Sternotomy 1 Uterine Myomas 1Stress Urinary Incontinence 1 Vaginal Prolapse 2Subarachnoid Hemorrhage Traumatic Brain Injury Intracranial 1 Vertebral Body Compression Fractures (VCFs) 1Superficial Femoral Artery Occlusions 1 Vertebral Osteomyelitis 1Superficial Thrombophlebitis Upper Extremity Superficial Thrombophlebitis Lower Extremity Superficial Thrombophlebitis 1 Vomiting 1Surgery 1 Vulvar Vestibulitis Vulvar Diseases 1Syndrome X 1 Wounds 1Tactile Hyperalgesia Neuropathic Pain 1Tennis Elbow Epicondylitis, Lateral Humeral 1Thyroid Neoplasm Goiter Thyroid Nodule 1Tonsillectomy 1Toothache 2Total Hip Replacement 1Total Knee Arthroplasty 1Trauma Pain 1Type 1 Diabetes Mellitus 1Type 2 Diabetic Peripheral Neuropathy (DPN) 1Undernutrition 1Unstable Angina Myocardial Infarction 1Unstable Angina Non-ST-Elevation Myocardial Infarction 1Upper Extremity Orthopedic Surgery Trauma Forearm Injuries 1