| 303 |
Vantas Implant Retrieval Study |
VANTAS® (histrelin acetate) subcutaneous implant |
|
| AUX-CC-802 |
A Phase 3, Open-Label Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for Up to Four Treatment Cycles (2 X 4) In Men With Peyronie's Disease |
XIAFLEX® (collagenase clostridium histolyticum) |
Completed
NCT01243411 |
| AUX-CC-806 |
A Phase 3, Open-Label Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for Up to Four Treatment Cycles (2 X 4) In Men With Peyronie's Disease |
XIAFLEX® (collagenase clostridium histolyticum) |
Completed
NCT01685437 |
| AUX-CC-807 |
A phase 3b, open-label pilot study to evaluate the safety and effectiveness of up to four treatment cycles of AA4500 in combination with the ErecAid® Esteem® Manual Vacuum Therapy System in men with Peyronie’s disease |
XIAPEX® (AA4500 [collagenase clostridium histolyticum]) |
Completed
EudraCT 2013-005384-66 |
| AUX-CC-831 |
A Phase 2, Randomized, Double-blind, Placebo-Controlled Dose Ranging Study of Repeat Doses of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy |
Collagenase clostridium histolyticum (CCH) |
Completed
NCT01987986 |
| AUX-CC-860 Year 5 |
Year 5 Final Annual Report of A Long-Term Follow-Up of Subjects Treated With AA4500 in Studies AUX-CC-854, AUX-CC-856, AUX-CC-857/AUX-CC-858, and AUX-CC-859 |
XIAFLEX® (collagenase clostridium histolyticum) |
|
| AUX-CC-862 |
Retreatment of Recurrent Contractures in Joints Effectively Treated with AA4500 (Collagenase Clostridium Histolyticum [XIAFLEX®/XIAPEX®]) in an Auxilium-Sponsored Phase 3 Study in the United States, Australia, and Europe |
XIAFLEX® (collagenase clostridium histolyticum) |
Completed
NCT01498640 |
| AUX-CC-864 |
An open-label study to assess the safety and efficacy of concurrent administration of two injections of AA4500 0.58 mg into the same hand of subjects with multiple Dupuytren's contractures |
XIAFLEX® (collagenase clostridium histolyticum) |
Completed
NCT01407068 |
| AUX-CC-901 |
COmmunity RegistRy Study Evaluating Dupuytren’s Contracture Treatment: A Prospective, Observational, Longitudinal, Multicenter Study of Treatment Patterns and Outcomes in Patients with Dupuytren's Contracture |
XIAFLEX® (collagenase clostridium histolyticum) |
|
| AUX-CC-902 |
A multicenter observational study of the real life effectiveness and safety of Xiapex® in the treatment of Dupuytren's disease in Belgium |
XIAFLEX®/XIAPEX® (collagenase clostridium histolyticum) |
|
| EN3202-012 |
Double-Blind, Placebo-Controlled, Parallel-Group Comparison of the Efficacy, Opioid Dose Sparing Effects and Safety of Controlled Release Oxymorphone and Placebo in Patients with Postsurgical Pain Following Knee Arthroplasty |
Oxymorphone controlled-release tablets |
|
| EN3202-015 |
Double-Blind, Placebo Controlled, Parallel Group, Dose Ranging Comparison of the Efficacy and Safety of Controlled Release Oxymorphone, Controlled Release Oxycodone (OxyContin®) and Placebo in the Treatment of Osteoarthritis of the Knee and/or Hip |
Oxymorphone controlled-release tablets |
|
| EN3202-016 |
Evaluation of the Efficacy and Safety of Numorphan® CR (Oxymorphone HCl Controlled Release) Relative to Placebo and OxyContin® (Oxycodone HCl Controlled Release) in Subjects with Chronic Low Back Pain |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
| EN3202-017 |
Open Label, Sequential Crossover Evaluation of the Analgesic Dose Equivalence, Efficacy and Safety of Controlled-Release Oxymorphone (Numorphan® CR) Relative to Controlled-Release Oxycodone (OxyContin®) and Controlled-Release Morphine (MS Contin®) in Patients With Cancer Pain |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
| EN3202-018 |
A Randomized, Double-Blind, Two-Period Crossover Trial Comparing the Safety and Effectiveness of Numorphan® CR (oxymorphone controlled-release tablets) and MS Contin® (morphine sulfate controlled release tablets) for the Relief of Moderate to Severe Pain in Patients with Cancer |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
| EN3202-019 |
A Randomized, Double-Blind, Two-Period Crossover Study Comparing the Efficacy, Safety and Tolerability of Numorphan® CR (Oxymorphone HCl, Controlled Release) and OxyContin® (Oxycodone HCl, Controlled Release) in Cancer Patients Who Require Chronic Opioid Treatments |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
| EN3202-020 |
A Multicenter, Open Label Extension Study to Evaluate the Long-term Safety and Effectiveness of Numorphan® CR in Patients with Chronic Pain |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
| EN3202-021 |
An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy of Numorphan® CR (oxymorphone HCl controlled release) in Subjects With Cancer Pain or Chronic Lower Back Pain |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
| EN3202-022 |
An Open-Label Assessment of the Long-Term Safety and Utility of Numorphan® CR for the Relief of Moderate to Severe Pain in Patients with Cancer |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
| EN3202-025 |
Double-Blind, Placebo Controlled, Parallel Group, Dose Ranging Comparison of the Efficacy and Safety of Extended Release Oxymorphone and Placebo in the Treatment of Osteoarthritis of the Knee and/or Hip |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
| EN3202-028 |
Safety and Efficacy Study of Oxymorphone Extended Release (ER) in Opioid-Naive Patients With Chronic Pain |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
| EN3202-029 |
Long-term Effectiveness and Safety Study of Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
| EN3202-031 |
Efficacy and Safety of Oxmorphone Extended Release in Opioid-Naive Patients with Chronic Low Back Pain |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
| EN3202-032 |
Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Low Back Pain |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
| EN3202-402 |
Study to Compare Subjective and Objective Effects of Oxymorphone Extended-Release (OPANA ER) Versus Oxycodone Controlled-Release (OxyContin) |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
Completed
NCT00955110 |
| EN3203-004 |
Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Ranging Comparison of the Analgesic Efficacy and Safety of Numorphan® IR (Oxymorphone HCl Immediate Release), Percolone, and Placebo in Patients With Postsurgical Pain Following Orthopedic Total Hip and Knee Replacement |
Oxymorphone hydrochloride immediate-release tablets |
|
| EN3203-005 |
A Multicenter, Randomized, Double-Blind, Placebo and Active Controls, Single-Dose Study of Oxymorphone IR and Oxycodone IR in Patients With Pain Following Orthopedic Surgery. |
Oxymorphone hydrochloride immediate-release tablets |
|
| EN3203-008 |
Post-operative Knee Surgery Efficacy and Safety Study |
OPANA® (oxymorphone hydrochloride) Tablets |
|
| EN3203-009 |
Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain |
OPANA® (oxymorphone hydrochloride) Tablets |
|
| EN3220-006 |
Open-label Efficacy Study of Topical Lidocaine Patch in Low Back Pain |
LIDODERM® (Lidocaine Patch 5%) |
|
| EN3220-008 |
A Study of the Effectiveness and Safety of Lidoderm® as Add-on Treatment in Patients with Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain |
LIDODERM® (Lidocaine Patch 5%) |
|
| EN3220-009 |
A Study of Lidocaine Patch 5% Alone, Gabapentin Alone, and Lidocaine Patch 5% and Gabapentin in Combination for the Relief of Pain in Patients with Diverse Peripheral Neuropathic Pain Conditions |
LIDODERM® (Lidocaine Patch 5%) |
|
| EN3220-011 |
Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain |
LIDODERM® (Lidocaine Patch 5%) |
|
| EN3220-012 |
Lidocaine Patch Versus Celecoxib in Pain From Osteoarthritis of the Knee |
LIDODERM® (Lidocaine Patch 5%) |
|
| EN3220-013 |
Lidocaine Patch 5% Versus Celecoxib 200 mg in Chronic Axial Low Back Pain |
LIDODERM® (Lidocaine Patch 5%) |
|
| EN3225-001 |
Open-Label Pilot Study Assessing the Efficacy and Safety of New Formulations of Percocet® in the Treatment of Low Back Pain |
PERCOCET® (oxycodone hydrochloride and acetaminophen USP) Tablets |
|
| EN3225-002 |
A Single-center, Randomized, Double-blind, Placebo-controlled, Single-dose Study of the Safety and Efficacy of Low-dose Percocet® Compared to OxyContin® in Patients With Acute Pain Following Third Molar Extraction |
PERCOCET® (oxycodone hydrochloride and acetaminophen USP) Tablets |
|
| EN3225-003 |
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of the Safety and Efficacy of Low-Dose Percocet® in Patients With Acute Pain Following Third Molar Extraction |
PERCOCET® (oxycodone hydrochloride and acetaminophen USP) Tablets |
|
| EN3260-001 |
Pilot Study of Lidocaine 5% Patch Versus Placebo in Patients With Osteoarthritis Pain of the Knee |
LIDODERM® (Lidocaine Patch 5%) |
|
| EN3260-003 |
Efficacy and Safety of the Lidoderm Patch 5% Applied to Patients With Osteoarthritis of the Knee |
LIDODERM® (Lidocaine Patch 5%) |
Completed
NCT00589979 |
| EN3261-001 |
A Study Comparing the Efficacy and Safety of Lidocaine 5% Patch With Placebo in Patients With Chronic Axial Low Back Pain |
LIDODERM® (Lidocaine Patch 5%) |
|
| EN3266-401 |
Effectiveness and Safety of Frovatriptan for the Management (Acute Treatment) of Menstrual Migraine |
FROVA® (frovatriptan succinate) Tablets |
|
| EN3272-301 |
Safety and Efficacy Study of Lidoderm (Lidocaine Patch 5%) Compared with Placebo in Treating Moderate to Severe Pain Associated With Carpal Tunnel Syndrome |
LIDODERM® (Lidocaine Patch 5%) |
|
| EN3288-108 |
An Open-Label, Randomized, Single-Dose, Six Period, Crossover Study to Evaluate the Relative Bioavailability of EN3288 40 mg Intact and After Physical Tampering Using Various Methods Compared with OPANA® 10 mg (4 × 10 mg) in Healthy Adult Subjects |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
| EN3288-109 |
A Randomized, Single-Dose, Double-Blind, Double-Dummy, Four-Period, Crossover Study to Evaluate the Relative Bioavailability and Subjective Effects of EN3288 40 mg Administered Intact and After Mastication Compared With OPANA® ER 40 mg Administered After Mastication and With OPANA® 40 mg (4 × 10 mg) Administered Intact in Healthy Non-Dependent Recreational Oral Prescription Opioid Users Experienced in Mastication of Extended-Release Opioid Formulations |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
| EN3288-113 |
A Double-blind, Dose-Ranging, Pilot Study to Evaluate the Safety, Subjective Effects, and Pharmacokinetics of Oxymorphone Hydrochloride in Healthy Subjects Who Recreationally Administer Opioids Intranasally |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
| EN3288-114 |
A Randomized Double-Blind, Single-Dose, Placebo-Controlled, Four-Period, Crossover Study to Evaluate the Subjective Effects and Systemic Exposure of Manipulated OPANA® ER Administered Intranasally Compared with Oxymorphone Hydrochloride Powder Administered Intranasally in Healthy, Non-Dependent Subjects Who Recreationally Administer Opioids Intranasally |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
| EN3288-901 |
Assessment of the ease with which experienced controlled-release prescription opioid abusers prepare a tamper-resistant formulation for intravenous use: comparison between OPANA® ER and oxymorphone HCl extended-release tamper-resistant tablets |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
| EN3288-902 |
Assessment of the ease with which experienced controlled-release prescription opioid abusers prepare a tamper-resistant formulation for intranasal use: comparison between OPANA® ER and oxymorphone HCl extended-release tamper-resistant tablets |
OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets |
|
| EN3319-301 |
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects |
Oxymorphone hydrochloride immediate-release oral liquid |
Withdrawn
NCT01206907 |
| EN3326-300 Former 03-CPP-HIS-300 |
Phase III Efficacy and Safety Study of Histrelin Subcutaneous Implant in Children With Central Precocious Puberty |
SUPPRELIN® LA (histrelin acetate) subcutaneous implant |
|
| EN3329-A9301/A9302 |
Intravesical AD 32 (valrubicin) in Patients With Carcinoma In Situ of the Bladder Who Have Failed or Have Recurrence Following Treatment with Bacillus Calmette-guerin (BCG) |
Valstar® (valrubicin) Sterile Solution |
|
| EN3330-301 |
Phase III Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer |
Vantas® (histrelin acetate) subcutaneous implant |
|
| EN3330-302 |
Phase III Study of Histrelin Subdermal Implant in Patients With Advanced Metastatic Prostate Cancer |
Vantas® (histrelin acetate) subcutaneous implant |
|
| EN3835-201 |
A Phase 2, Randomized, Double-blind, Placebo-controlled Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy |
Collagenase clostridium histolyticum (CCH) |
Completed
NCT02724644 |
| EN3835-202 |
A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy |
Collagenase clostridium histolyticum (CCH) |
Completed
NCT02942160 |
| EN3835-205 |
A Phase 2 Open-label Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy |
Collagenase clostridium histolyticum (CCH) |
Completed
NCT03329989 |
| EN3835-209 |
A Phase 2A, Open-Label Study Evaluating the Safety and Different Injection Techniques of CCH for the Treatment of Edematous Fibrosclerotic Panniculopathy (EFP) |
Collagenase clostridium histolyticum (CCH) |
Completed
NCT03632993 |
| EN3835-210 |
A Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis |
Collagenase clostridium histolyticum EN3835 |
Completed
NCT04496167 |
| EN3835-212 |
A Phase 2a, Open Label Study to Assess the Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Females Using Photonumeric Scales, Magnetic Resonance Imaging and Histopathology |
Collagenase clostridium histolyticum (CCH) |
Terminated
NCT04209530 |
| EN3835-213 |
A Phase 2B, Open-Label Study to Explore Tissue Histopathology Following Subcutaneous Injection of Collagenase Clostridium Histolyticum Using An Abdominoplasty Model |
Collagenase clostridium histolyticum (CCH) |
Completed
NCT04236635 |
| EN3835-219 |
A Phase 2b, Open Label Durability Study of EN3835 Following Treatment of Edematous Fibrosclerotic Panniculopathy |
No treatment to be administered - Observational only |
Completed
NCT03893890 |
| EN3835-220 |
A Phase 2B, Open-Label Long-Term Durability Study of CCH Following Treatment of Edematous Fibrosclerotic Panniculopathy (Cellulite) |
No treatment to be administered - Observational only |
Completed
NCT04381117 |
| EN3835-222 |
A Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis |
Collagenase clostridium histolyticum EN3835 |
Completed
NCT05152173 |
| EN3835-223 |
An Observational, Double-blind (Sponsor Open), Long-term Study to Evaluate the Safety and Durability (Efficacy) of Response to EN3835 compared to Placebo in the Treatment of Adhesive Capsulitis of the Shoulder (Frozen Shoulder) |
No treatment to be administered |
Completed
NCT04680156 |
| EN3835-224 |
A Phase 2 Multicenter, Open-Label, Randomized, Parallel-Group, Multiple-Dose Study to Assess the Effectiveness, Safety and Satisfaction With Collagenase Clostridium Histolyticum Grid Technique Injections of Buttock or Thigh Cellulite With Laxity in Adult Females |
Collagenase clostridium histolyticum (CCH) |
Completed
NCT04580303 |
| EN3835-225 |
A Phase 2, Multicenter, Observational Study to Assess the Durability and Safety of Collagenase Clostridium Histolyticum Injected With GRID Technique in Buttocks or Thigh Cellulite With Laxity in Adult Females |
Collagenase clostridium histolyticum EN3835 |
Completed
NCT05249257 |
| EN3835-302 |
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (Cellulite)
(RELEASE-1) |
Collagenase clostridium histolyticum (CCH) |
Completed
NCT03428750 |
| EN3835-303 |
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (Cellulite)
(RELEASE-2) |
Collagenase clostridium histolyticum (CCH) |
Completed
NCT03446781 |
| EN3835-304 |
A Phase 3b, Open-Label, Long-Term Study to Evaluate the Safety and Temporal Pattern of Response of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (EFP) |
Collagenase clostridium histolyticum (CCH) |
Completed
NCT03526549 |
| EN3835-305 |
A Real World, Multicenter, Open-Label, Multiple Dose Study to Assess the Effectiveness of, and Satisfaction with, CCH Treatment of Buttocks or Thigh Cellulite in Adult Females |
Collagenase clostridium histolyticum (CCH) |
Completed
NCT04170296 |
| EN3835-401 (MOBI-1) |
A Collaborative Research, Open-Label Study to Assess Effects of Mitigation Treatments on Bruising of CCH-Aaes Treatment of Buttock Cellulite in Adult Females |
QWO™ |
Completed
NCT04677712 |
| FOR01C |
A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone |
FORTESTA® (testosterone) Gel |
Completed
NCT00522431 |
| IP157-001 |
Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men |
AVEED® (testosterone undecanoate) injection |
Completed
NCT00467870 |
| IP157-003 |
Phase I, Double-Blind Study to Evaluate the Allergic Potential of NEBIDO® and Formulation Components in Patients Who Have Exhibited Anaphylactic-Like Reactions Following Intramuscular Injection of NEBIDO® |
NEBIDO® (testosterone undecanoate)*
*Bayer Pharma AG |
|
| VML 251-3MRM02 |
A Controlled Trial to Investigate the Efficacy and Safety of Frovatriptan to Prevent Menstrual Migraine |
FROVA® (frovatriptan succinate) Tablets |
|
| VML 251-3MAM03 |
Safety and Tolerability of Frovatriptan in Prevention of Menstrually Associated Migraine (MAM) Headaches |
FROVA® (frovatriptan succinate) Tablets |
|