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Cipla
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Generated: November 15, 2018

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CLINICAL TRIALS PROFILE FOR ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

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Clinical Trials for Ondansetron Hydrochloride Preservative Free

Trial ID Title Status Sponsor Phase Summary
NCT01055236 Hydroxyzine for the Prevention of Pruritus From Spinal Morphine in Transabdominal Hysterectomy Patients Completed Mahidol University Phase 4 Hydroxyzine is one of antihistamines that antagonizes H1 receptor, and it's effects are reducing pruritus, nausea/vomiting, and the mild effect of sedation.With these effects Hydroxyzine should be used in the prevention of these symptoms.
NCT01236859 Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus Completed Prince of Songkla University N/A Intrathecal morphine provides good postoperative analgesia for up to 18-24 hour after administration. Pruritus is the most common side effect of intrathecal morphine, which the incidence was reported as 20%-100%2 and 63% in Songklanagarind Hospital. Pathophysiology of opioid-induced pruritus remain unclear and more than one mechanism may be involved in the development of opioid-induced pruritus, such as, mediated central ยต opioid receptors, Dopamine (D2) receptors, Serotonin (5-HT3) receptors, prostaglandin system, GABA receptors, and glycine receptors, so that why opioid-induced pruritus is difficult to manage. Many medications have been used to treat this side effect included antihistamines, 5-HT3 (serotonin) receptor antagonists, opioid antagonists, opioid agonist-antagonists, propofol, and nonsteroidal antiinflammatory drugs. Gabapentin is an anticonvulsant, a structural analog of aminobutyric acid, and currently approved by the Food and Drug Administration for the treatment of partial seizures and postherpetic neuralgia. Many studies have shown gabapentin to be effective in the case of brachioradial pruritus, itch of neuropathic in origin, uremic pruritus, multiple sclerosis-induced pruritus,cholestatic pruritus, itch produced by burn, and pruritus of unknown origin. However, there is only one small study in Taiwan shown the effectiveness of gabapentin 1200 mg in prevention of intrathecal morphine-induced pruritus in orthopedic surgery, which could reduce incidence of pruritus from 77.5% to 47.5% (38.7% reduction). Because gabapentin has several side effects especially in high dose such as drowsiness, dry mouth, headache, unsteadiness, reduced co-ordination or slowed reaction, constipation, diarrhea, peripheral edema, dizziness, confusion, loss of concentration, weight gain, and nausea, vomiting, so in our study we decided to reduce the dose of gabapentin. Therefore, we would like to know if gabapentin in a smaller dose (600 mg) used in the wider range of age including the elderly can decrease the incidence of intrathecal morphine-induced pruritus in orthopedic surgery in Songklanagarind Hospital.
NCT01414777 Intravenous Ondansetron to Attenuate the Hypotensive, Bradycardic Response to Spinal Anesthesia in Healthy Parturients Enrolling by invitation University of Virginia Phase 2/Phase 3 The investigators hypothesize that given prophylactically, intravenous ondansetron will attenuate the drop in blood pressure and heart rate frequently seen after spinal anesthesia. Eighty-six American Society of Anesthesiologists (ASA) physical status I or II in preoperative patient assessment, parturients age of 18 to 45 years scheduled to undergo elective caesarean section will be enrolled. Patients will be randomized to 2 groups: the ondansetron group, receiving 8 mg intravenous ondansetron diluted in 10 mL of saline; or the placebo group, who were administered 10 mL of saline given 5 minutes prior to performing the spinal anesthetic. Investigational Pharmacy will randomize and dispense study drug. Baseline measurements of vital signs will be taken. Otherwise standard management will then be used: - Patients must be NPO for 8 hours - Pulse oximetry, EKG monitoring, noninvasive blood pressure at a minimum of every 3 minutes, more frequently if decided by the provider. - Standard lumbar puncture in a sitting position the L3-L4 or L4-L5 - Whitacre pencil-point, 25 gauge - Injectate: 2 mL of 0.75% hyperbaric bupivacaine, 100 mcg preservative free morphine, 20 mcg fentanyl - Immediately after completing the subarachnoid injection, patients will be laid supine with left lateral uterine displacement The sensory level of anesthesia will be assessed in the standard fashion every five minutes using ice. The motor component will tested using the Bromage scale for spinal anesthesia (0, no paralysis; 1, inability to lift the thigh [only knee/feet]; 2, inability to flex the knee [only feet]; 3, inability to move any joint in the legs).
NCT01593280 TAP Catheters Versus Intrathecal Morphine for Cesarean Section Unknown status I-Flow N/A Morphine, when given as part of spinal anesthesia, is associated high incidence of nausea and pruritus, which may affect quality of recovery. The investigators hypothesize that long-acting local anesthetic infusions via TAP catheter can provide better quality of recovery after cesarean section than spinal morphine.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ondansetron Hydrochloride Preservative Free

Condition Name

Condition Name for Ondansetron Hydrochloride Preservative Free
Intervention Trials
Pruritus 2
Hemodynamic Instability 1
Nausea 1
Anesthesia; Spinal 1
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Condition MeSH

Condition MeSH for Ondansetron Hydrochloride Preservative Free
Intervention Trials
Pruritus 2
Pain, Postoperative 1
Hypotension 1
Vomiting 1
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Clinical Trial Locations for Ondansetron Hydrochloride Preservative Free

Trials by Country

Trials by Country for Ondansetron Hydrochloride Preservative Free
Location Trials
United States 4
Thailand 2
Canada 1
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Trials by US State

Trials by US State for Ondansetron Hydrochloride Preservative Free
Location Trials
Pennsylvania 1
West Virginia 1
Connecticut 1
Virginia 1
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Clinical Trial Progress for Ondansetron Hydrochloride Preservative Free

Clinical Trial Phase

Clinical Trial Phase for Ondansetron Hydrochloride Preservative Free
Clinical Trial Phase Trials
Phase 4 3
Phase 2/Phase 3 1
N/A 4
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Clinical Trial Status

Clinical Trial Status for Ondansetron Hydrochloride Preservative Free
Clinical Trial Phase Trials
Completed 2
Recruiting 2
Terminated 1
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Clinical Trial Sponsors for Ondansetron Hydrochloride Preservative Free

Sponsor Name

Sponsor Name for Ondansetron Hydrochloride Preservative Free
Sponsor Trials
University of Manitoba 1
Stamford Anesthesiology Services, PC 1
I-Flow 1
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Sponsor Type

Sponsor Type for Ondansetron Hydrochloride Preservative Free
Sponsor Trials
Other 8
Industry 1
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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Cipla
AstraZeneca
Mallinckrodt
Teva
Accenture
Deloitte
Chubb
Covington

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