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This is the category page. Below are all of the research programs that are associated with it
- Chronic Intractable Pain -
A RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL DOSE RESPONSE STUDY OF GABAPENTIN INJECTION FOR INTRATHECAL ADMISISTRATION IN SUBJECTS WITH CHRONIC, INTRACTABLE PAIN (PROTOCOL #01622)
(1_20070403_118)
This is a randomized, double-blind, placebo-controlled study. This study will use a non-FDA approved drug, Gabapentin – does include 1mg/day, 6mg/day & 30mg/day or placebo. This therapy can continue indefinitely until either IND closure or FDA approval. All participants successfully completing the blinded phase, Part 1 of this study will be offered the option of long-term, open-label treatment with Gabapentin Injection (Part 2). If subjects withdraw from the study during Part 1 for any reason other than an intolerable adverse event, they will not have the option of entering into the open-label portion of the study.
- Multiple Sclerosis -
A PHASE 3 RANDOMIZED, RATER-AND -BLINDED STUDY COMPARING TWO ANNUAL CYCLES OF INTRAVENOUS LOW – AND – HIGH DOSE ALEMTUZUMAB TO THREE-TIMES WEEKLY SUBCUTANEOUS INTERFERON BETA-1a (Rebif®) IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS WHO HAVE REPLAPSED ON THERAPY(PROTOCOL CAMMS32400507)
(1_20080611_118)
This is a randomized, rater-blinded study of the safety and efficacy of alemtuzumab in patients with relapsing-remitting multiple sclerosis (RRMS) who have experienced a relapse on therapy after having been on therapy for at least 6 months. Each participant will be on the study for two years. Participants will be randomized to one of three arms which include 2 annual cycles of low dose Alemtuzumab; 2 annual cycles of high dose Alemtuzumab; or 3 times weekly subcutaneous interferon beta-1a. Participants must be able to complete necessary questionnaires.
- Neuopathic Pain -
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF JNJ-42160443 IN SUBJECTS WITH POSTHERPETIC NEURALGIA AND POST-TRAUMATIC NEURALGIA, FOLLOWED BY A DOUBLE-BLIND SAFETY EXTENSION AND OPEN-LABEL SAFETY EXTENSION
(2_20091006_118)
This is a multi-center trial using an investigational drug JNJ-42160443 in patients with neuropathic pain. This will be a 12 week study. Following this study, the participant will have the option to continue in a 40 week safety extension study; followed by the option to continue on in to a 52 week open label phase of the study. Participants wanting to continue on to the third phase (52 week open label) will need to complete the first two phases. In the first phase, participants will need to report to the doctor’s office for monthly injections of the study drug. There will be a total of 7 visits to the office and 5 telephone calls. In phase 2, the participant will continue to report to the doctor’s office monthly for injections. During the 2nd phase, there will be approximately 12 office visits and 1 telephone call. In the final phase, phase 3, the participant will have approximately 15 office visits and one telephone call. Participants will have several safety evaluations at each visit including a 30 minute post injection site assessment. Following the treatment period, the participant will have a 26 week post treatment follow-up.
- Pain -
OPEN-LABEL EXTENSION, SINGLE-ARM, FLEXIBLE-DOSING, PHASE III TRIAL WITH CG5503 EXTENDED-RELEASE (ER) IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PAIN (PROTOCOL #KF5503/18-PAI-3010)(1_20070804_118)
This study is the open label extension to the initial study #1-20070301. Patients will be identified as those who completed the double-blind study, no new patients will be recruited. Dose rage will be from 100 mg to 250 mg BID. The dose may be reduced or increased to provide optimal therapeutic benefit. The active treatment period will last for one year.
- Pain-Post Shoulder Surgery:
A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, PARALLEL-GROUP STUDY OF TAPENTADOL IMMEDIATE RELEASE (IR) VS OXYCODONE IR FOR THE TREATMENT OF SUBJECTS WITH ACUTE POST-OPERATIVE PAIN FOLLOWING ELECTIVE ARTHROSCOPIC SHOULDER SURGERY (Protocol R33133PAI3022 (OMJSA)
(1_20090607_118)
This is a study of a new FDA approved drug Tapentadol immediate release and Oxycodone immediate release to evaluate the effectiveness and safety of Tapentadol. Participant’s pain scores will be collected over a 7 day period following surgery. The total length of participation will be approximately 14 days. Following the participants surgery, they will receive the supply of study medication prior to being discharged from the hospital. The participant will be instructed on the dosing schedule to be used while they are at home. Follow-up phone calls will be completed to assess the patient’s compliance and understanding of the dosing schedule.
- Study Closed to Accrual:
Breakthrough Cancer Pain -
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FENTANYL SUBLINGUAL SPRAY (FENTANYL SL SPRAY) FOR THE TREATMENT OF BREAKTHROUGH CANCER PAIN (PROTOCOL #INS-05-001)(1_20071103_118)
Participants will be entered into the titration portion of the study for a maximum of 21 days to establish the successful dose of Fentanyl SL Spray required to effectively treat their breakthrough pain. Subjects who have established a successful dose of Fentanyl SL Spray will be entered into the randomized, double-blind, placebo-controlled period of the study for a maximum of 21 days to determine the efficacy of the Fentanyl SL Spray does selected compared to placebo treatment in management of breakthrough cancer pain. Subjects will need to complete pain assessments from baseline until 60 minutes after dosing and a subjects Global Evaluation of Study Medication at 30 minutes and 60 minutes after each dose of study medication.
- Study Closed to Accrual:
Multiple Sclerosis -
A PHASE 3 RANDOMIZED, RATER-BLINDED STUDY COMPARING TWO ANNUAL CYCLES OF INTRAVENOUS ALEMTUZUMAB TO THREE-TIMES WEEKLY SUBCUTANEOUS INTERFERON BETA-1a (Rebif®) IN TREATMENT-NAÏVE PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS
(1_20080604_118)
This is a randomized, rater-blinded study of the safety and efficacy of alemtuzumab in treatment-naïve patients with relapsing-remitting multiple sclerosis (RRMS). Participants will be randomized to one of two treatment arms. Participants will be randomized to either 2 annual cycles of intravenous alemtuzumab or to 3 times weekly subcutaneous interferon beta-1a. Participants will be treated for at least two years and then safety follow-up for three years.
- Study Closed to Accrual: Pain - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2a PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY OF MAXIMALLY TOLERATED DOSES OF RETIGABINE VS. PLACEBO IN REDUCING THE PAIN ASSOCIATED WITH POST HERPETIC NEURALGIA (Protocol VRX-RET-E22-NP201)
(1_20080101_118)
This is a randomized, double-blind, placebo-controlled Phase IIA study using retigabine and placebo. The study will consist of a Screening Phase of 2-week washout for patients taking more than one medication; a 1-week baseline phase; a double-blind Titration Phase up to 6 weeks to determine the maximally tolerated doses; a 4 week double-bond Maintenance Phase; and a 3 week Taper Phase. If participants experience moderate to severe side effects, a decrease of one dose level will be allowed during the 1st week of the maintenance Phase
- Total Knee Replacement -
A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY, OF THE EFFICACY AND SAFETY OF PREGABALIN IN THE TREATMENT OF SUBJECTS WITH POST-OPERATIVE PAIN FOLLOWING TOTAL KNEE ARTHROPLASTY (TKA)(PROTOCOL #A0081133)
(1_20070602_118)
The study will involve approximately 300 patients undergoing elective total knee arthroplasty under regional anesthesia. There will be three treatment groups with approximately 100 patients assigned to each group. The three groups will receive a fixed dose of Pregabalin 150 mg/day; or Pregabalin 300 mg/day, or matching placebo. All treatments will be started pre-operatively with 2 single doses at approximately 12 and 2 hours before surgery and continue twice a day for up to 6 weeks following surgery. The study duration will be approximately 6 months and will also include site visits following surgery on weeks 2, 4, 6 and 7; and phone call follow-up will be done at 3 and 6 months.
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