PIONEERING BUT SAFE
Clinical Research Center
OPIOID DEPENDENCE | PHASE 3
Induction, Stabilization, Adherence and Retention Trial (ISTART)-A randomized non-inferiority multicenter study to assess early treatment efficacy of OX 219 (combination of Buprenorphine and Naloxone) versus Suboxone and to explore switching between treatments. Phase 3 study.
PERIPHERAL NEUROPATHIC PAIN | PHASE 3
A phase 3, randomized double blind placebo controlled parallel group study of the efficacy and safety of pregabalin (twice a day) in subjects with post–traumatic peripheral neuropathic pain.
PERIPHERAL NEUROPATHIC PAIN |
Double blind, randomized, placebo-controlled, multiple -dose parallel group study of the efficacy and safety of multiple doses of tolperisone administered as multiple doses three times daily in 400 male and female.
TREATMENT FOR ADULTS | PHASE 3
A phase 3, Multicenter, Randomized, Double-blind Trial of Fixed-Dose Brexpiprazole as Combination Therapy with Sertraline in the Treatment of Adults with Post-traumatic Stress Disorder.
DIABETES MELLITUS TYPE II | PHASE 3
A phase 3, randomized, 16 weeks, multiphase, double-blind, placebo controlled dose ranging study to evaluate glycemic effect, safety and tolerability of metformin delayed release in subjects with type II diabetes mellitus.
CHRONIC NEUROPATHIC PAIN | PHASE 4
Medtronic products surveillance registry version 6 (PSR-V6). The purpose of the PSR platform is to provide continuing evaluation and periodic reporting of the safety and effectiveness of market released products for their intended use. Products surveillance is the systematic collection, analysis, and interpretation of performance data as well as its dissemination and application. Phase 4 study (Chronic Neuropathicpain).
COMPLETED TRIALS
CHRONIC LOW BACK PAIN & OPIOID | PHASE 3
Opioid-experienced in subjects with moderate to severe chronic low back pain
A Phase 3 Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled , Parallel group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects With Uncontrolled Moderate to Severe Chronic Low back Pain and a History of Opioid-induced Constipation who require Around-the-clock Opioid therapy.
SAFETY EFFICACY EVALUATION
Adults experiencing non-idiopathic constipation
A safety and efficacy evaluation of BLI801 Laxative in Adults Experiencing Non-Idiopathic constipation.
CHRONIC PAIN & OPIOD THERAPY | PHASE 3
Subjects with non-malignant chronic pain receiving opioid therapy
A phase 3 randomized, double-blind, placebo-controlled, parallel-group Study of Naldemedine in the treatment of Opioid-induced Constipation in Subjects with Non-malignant Chronic Pain Receiving Opioid Therapy.
COMPLETED TRIALS
Sciatica Study
● A phase 2A, open label, Sequential, Dose Escalation Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of MDT-15 in subjects with Lumbosacral Radiculopathy.
● A Prospective Multicenter Randomized Double-Blind Sham Controlled study to evaluate the efficacy and safety of Clonidine Micro pellets for the treatment of pain associated with lumbosacral radiculopathy in Adults
● Phase 3 study. We participated in an international trial (the US and Japan) to help develop a minimally invasive treatment for treating disc herniation, causing sciatica and back pain.
Degenerative Dic Disease - Stem Cell Clinical Trial
● A phase 3 prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single injection of Rexlemastrocel-Lalone or combined with hyaluronic acid in subjects with chronic discogenic lumbar back pain through 12months.
● Phase I, first in human, randomized, double-blind, vehicle and placebo-controlled, parallel group, multi-center study in subjects with single level, symptomatic lumbar intervertebral disc degeneration (>6 months) and unresponsive to conservative therapy for at least 3 months. The study will compare single intradiscal injections of high and low dose IDCT with two control groups (saline, Sodium Hyaluronate).
Degenerative Disc Disease - Non Specific Low Back Pain
● A phase 3 randomized, double-blind, placebo and active controlled multicenter, parallel group study of the analgesic efficacy and safety of subcutaneous administration of Tanezumab in the adult subjects with chronic low backpain.
● A Phase 3 Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled , Parallel group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects With Uncontrolled Moderate to Severe Chronic Low back Pain and a History of Opioid-induced Constipation who require Around-the-clock Opioid therapy.
● A Phase III, Randomized, Double-Blind, Placebo-Controlled, Enriched-Enrollment Withdrawal, Multicenter Study to Evaluate the Efficacy and Safety of a Long-Acting SubcutaneousInjectable Depot of Buprenorphine (CAM2038) in Subjects with Moderate to Severe Chronic Low Back Pain Currently Treated with Daily Opioid.
● A phase 3, Randomized, Double blind, Placebo controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients with Moderate to Severe Chronic Low back pain and Osteoarthritis of Hip or Knee ( Study was put on hold in (2018 March).
Osteoarthritis Joint Pain - Degenerative Joint Disease
● A phase 3, randomized, 16 weeks, multi-phase, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of Fulranumab as a monotherapy in subjects with signs and symptoms of osteoarthritis of the hip or knee. A phase 3 randomized, double-blind, placebo and active controlled multicenter, parallel group study of the analgesic efficacy and safety of subcutaneous administration of Tanezumab in the adult subjects with chronic low backpain.
● A phase 3 randomized, double-blind, double dummy, placebo controlled, active controlled, parallel group, multicenter trial of oxycodone/ naloxone controlled release tablet (OXN) to assess the analgesic efficacy (compared to placebo) and the management of opioid-induced constipation (compared to oxycodone controlled release tablets (OXY) in opioid experienced subjects with uncontrolled moderate to severechronic low back pain and a history of opioid- induced constipation who required around-the-clock opioid therapy.
COMPLETED TRIALS
MIGRAINE PREVENTION IN PATIENTS WITH EPISODIC MIGRAINE | PHASE 3
A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of multiple dosing regimens of oral ATOGEPANT for the prevention of migraine in patients with episodic migraine.
EPISODIC MIGRAINE | PHASE 2B
A phase IIb Randomized, double-blind, placebo-controlled study of LY2951742 in patients with episodic migraine.
EPISODIC MIGRAINE | PHASE 3
A phase 3, randomized, double-blind, and placebo-controlled study of LY2951742. Patient with episodic migraine.
MIGRAINE PREVENTION | PHASE 3
A phase 3, randomized, double-blind, parallel group, multi center placebo-controlled dose ranging study to evaluate the efficacy and safety of AMG 334 in migraine prevention.
MIGRAINE SUMMIT STUDY | PHASE 1
The SUMMIT study is a clinical research study evaluating a new investigational medicine for the acute treatment of migraines.
COMPLETED TRIALS
Adults with Inadequate reponse to Antidepressant Therapy
● ALK5461-208, A phase 3 multicenter study of the long-term safety and tolerability of ALKS 5461 for the adjunctive treatment of major depressive disorder in adults who have been inadequate response to antidepressant therapy (the FORWARD-2Study).
● ALK5461-208, A phase 3 multicenter study of the long-term safety and tolerability of ALKS 5461 for the adjunctive treatment of major depressive disorder in adults who have been inadequate response to antidepressant therapy (the FORWARD-3Study).
Adults with Major Depressive Disorder with Inadequate Response to Antidepressant
● The SPD 489-322 A phase 3, multicenter, randomized, double-blind, parallel group, placebo- controlled, flexible dose titration, efficacy and safety study of SPD 489 incombination with an antidepressant in the treatment of adults with major depressive disorder with inadequate response to prospective treatment with an antidepressant(Sub-Investigator).
● The SPD 489-322 A phase3, open label, multicenter, 12-month extension safety and tolerability study of SPD 489 in combination with an antidepressant in the treatment of adults with major depressive disorder with residual symptoms of inadequate response following treatment with an anti-depressant(SI).
Monoaminergic Antidepressant in Adults with Major Depressive Disorder
A Phase II a double blind, placebo controlled multicenter study of Sirukumab as adjunctive treatment to a monoaminergic antidepressant in adult with Major Depressive Disorder (SI).
Postpartum Depression
● A multicenter, randomized double-blind, parallel-group, placebo-controlled studies evaluation the efficacy, safety, and pharmacokinetics of SAGE-547 injection in the treatment of adult female subjects with severe postpartum depression and adult female subjects with moderate postpartum depression. 547-PPD-202.
● A multicenter, double blind, placebo-controlled study evaluation the efficacy, safety, tolerability, and pharmacokinetics of Brexanolone in the treatment of adolescent female subjects with postpartum depression. Protocol Number: 547-PPD-304.