Clinical trials: Withdrawal Symptoms
Chronic Kidney Disease
Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis
The primary objective of this study is to demonstrate the superiority of MCI-196 over placebo and non-inferiority with simvastatin in reducing serum low-density lipoprotein (LDL)-cholesterol in subjects with chronic kidney…
- Trial name
- NCT00858637
- Testing
- MCI-196, Simvastatin
- Where
- 39 sites in Belarus, Bulgaria and 11 more
- Volunteers
- 260 people
- Sponsor
- Tanabe Pharma Corporation
Opioid-related Disorders
Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone
The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active…
- Trial name
- NCT00637000
- Testing
- Buprenorphine soluble film, Buprenorphine/naloxone film strip
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Indivior Inc.
Psoriasis
A Study To Evaluate The Effects And Safety Of Treatment, Treatment Withdrawal, Followed By Re-Treatment With CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and subsequent withdrawal of active treatment at…
- Trial name
- NCT01186744
- Testing
- CP-690,550
- Where
- 87 sites in United States, Argentina and 10 more
- Volunteers
- 666 people
- Sponsor
- Pfizer
Chronic Pain, Low Back Pain
A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain
The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.
- Conditions
- Chronic Pain, Low Back Pain, Analgesia
- Trial name
- NCT01571362
- Testing
- ALO-02
- Where
- 52 sites in United States
- Volunteers
- 410 people
- Sponsor
- Pfizer
Schizophrenia
Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia
The purpose of this study is to investigate the effects of flexibly dosed Brexpiprazole monotherapy in the improvement of early-episode schizophrenia through the assessment of social functioning, efficacy, and tolerability.
- Trial name
- NCT02013622
- Testing
- Brexpiprazole
- Where
- 22 sites in United States
- Volunteers
- 49 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Low Back Pain
Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain
The primary objective of this study is to evaluate the efficacy of hydrocodone bitartrate extended-release tablets at doses of 30 to 90 mg every 12 hours compared with placebo in alleviating moderate to severe pain in patients…
- Trial name
- NCT01789970
- Testing
- Hydrocodone ER
- Where
- 87 sites in United States
- Volunteers
- 625 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Essential Tremor
A Study to Evaluate SAGE-217 in Participants With Essential Tremor
This study is a three-part, multicenter, Phase 2a study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of SAGE-217 in adult participants with essential tremor.
- Trial name
- NCT02978781
- Testing
- SAGE-217
- Where
- 26 sites in United States
- Volunteers
- 34 people
- Sponsor
- Biogen
Schizophrenia and Predominant Negative Symptoms
Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms
To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as…
- Trial name
- NCT00922272
- Testing
- SPD489 (lisdexamfetamine dimesylate)
- Where
- 27 sites in United States
- Volunteers
- 92 people
- Sponsor
- Shire
Chronic Kidney Disease, Autosomal Dominant Polycystic Kidney Disease
Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
The purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (ADPKD)
- Trial name
- NCT02160145
- Testing
- Tolvaptan (OPC-41061)
- Where
- 230 sites in United States, Argentina and 20 more
- Volunteers
- 1,370 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Chronic Pain
Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients
This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are stabilized on EMBEDA.
- Trial name
- NCT01100437
- Testing
- EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush, EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Pfizer
Neuralgia, Postherpetic, Diabetic Neuropathy
Neuropathic Pain Syndrome Patient Study (MK-0000-072)
The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.
- Conditions
- Neuralgia, Postherpetic, Diabetic Neuropathy, Painful Small-Fiber Neuropathy, Idiopathic Distal Sensory Polyneuropathy
- Trial name
- NCT00570310
- Testing
- Comparator: pregabalin
- Volunteers
- 104 people
- Sponsor
- Merck Sharp & Dohme LLC
Irritable Bowel Syndrome With Diarrhea
12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea.
- Trial name
- IRIS-3 (NCT02107196)
- Testing
- Ibodutant 10 mg
- Where
- 127 sites in United States, Bulgaria and 9 more
- Volunteers
- 535 people
- Sponsor
- Menarini Group
Bipolar I Disorder, Mania
A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
1) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e.
- Conditions
- Bipolar I Disorder, Mania, Depression
- Trial name
- NCT03573297
- Testing
- Cariprazine
- Where
- 108 sites in United States, Bulgaria and 9 more
- Volunteers
- 901 people
- Sponsor
- AbbVie
Chronic Lower Back Pain, Chronic Pain
Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain
This is a Phase III, placebo-controlled, multicenter study with an enriched-enrollment withdrawal (EEW) design to evaluate the efficacy and safety of CAM2038 in opioid-experienced subjects with moderate to severe CLBP that…
- Trial name
- CAM2038 (NCT02946073)
- Testing
- buprenorphine
- Where
- 69 sites in United States
- Volunteers
- 1,053 people
- Sponsor
- Braeburn Pharmaceuticals
Non-24-Hour Sleep-Wake Disorder
Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder
The purpose of this study is to evaluate the maintenance effect and safety of 20 mg tasimelteon versus placebo in subjects suffering from Non-24-Hour Sleep-Wake Disorder.
- Trial name
- NCT01430754
- Testing
- tasimelteon
- Where
- 22 sites in United States
- Volunteers
- 20 people
- Sponsor
- Vanda Pharmaceuticals
Chronic Kidney Disease, Dialysis
A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia
This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the third period is a placebo-controlled withdrawal…
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- Trial name
- NCT00506441
- Testing
- MCI-196
- Where
- 39 sites in United States, Puerto Rico
- Volunteers
- 245 people
- Sponsor
- Tanabe Pharma Corporation
Asthma
AZD1419 Ph2a Study
Ph2a study planned to be run at approximately 16-18 sites in 4 EU countries (Denmark, Hungary, Poland and Sweden) enrolling approximately 170 patients to ensure 70 randomized patients with eosinophilic, moderate to severe asthma.
- Trial name
- INCONTRO (NCT02898662)
- Testing
- AZD1419
- Where
- 15 sites in Denmark, Hungary and 2 more
- Volunteers
- 81 people
- Sponsor
- AstraZeneca
Colorectal Neoplasms
Impact of Experience on Results With the Third Eye Retroscope
The Third Eye Retroscope is a device that can be used with a colonoscope to improve the ability of a physician to see areas of the colon that may be hidden from the view of the colonoscope.
- Trial name
- NCT00969124
- Testing
- Third Eye Retroscope
- Where
- 9 sites in United States
- Volunteers
- 328 people, healthy volunteers welcome
- Sponsor
- Avantis Medical Systems
Hyperkalemia
Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)
The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.
- Trial name
- DIAMOND (NCT03888066)
- Testing
- Patiromer
- Where
- 415 sites in United States, Argentina and 19 more
- Volunteers
- 1,195 people
- Sponsor
- Vifor Pharma, Inc.
Pain, Neoplasm
A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine
The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo.
- Conditions
- Pain, Neoplasm, Cancer
- Trial name
- NCT00505414
- Testing
- Tapentadol in the Titration Phase, Morphine in the Maintenance Phase, Tapentadol in the Maintenance Phase
- Where
- 37 sites in United States, Argentina and 4 more
- Volunteers
- 136 people
- Sponsor
- Grünenthal GmbH