CLINICAL TRIALS PROFILE FOR ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

All Clinical Trials for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01593280 ↗	TAP Catheters Versus Intrathecal Morphine for Cesarean Section	Unknown status	I-Flow	N/A	2012-05-01	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.
NCT01414777 ↗	Intravenous Ondansetron to Attenuate the Hypotensive, Bradycardic Response to Spinal Anesthesia in Healthy Parturients	Unknown status	University of Virginia	Phase 2/Phase 3	2009-11-01	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).
NCT01236859 ↗	Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus	Completed	Prince of Songkla University	N/A	2009-09-01	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 µ 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.
NCT01055236 ↗	Hydroxyzine for the Prevention of Pruritus From Spinal Morphine in Transabdominal Hysterectomy Patients	Completed	Mahidol University	Phase 4	2007-08-01	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.

Clinical Trial Conditions for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Condition Name

Condition Name for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Intervention	Trials
Pruritus	3
Anesthesia; Spinal	1
Vomiting	1
Humans	1

Condition MeSH

Condition MeSH for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Intervention	Trials
Pruritus	3
Hypotension	2
Vomiting	2
Nausea	2

Clinical Trial Locations for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Trials by Country

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Trials by Country for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Location	Trials
United States	16
Thailand	2
Canada	1
Brazil	1
Czechia	1

Trials by US State

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−

Trials by US State for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Location	Trials
Pennsylvania	2
West Virginia	2
Virginia	2
Texas	1
Ohio	1

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	5
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Clinical Trial Phase	Trials
Completed	7
Unknown status	2
Terminated	1

Clinical Trial Sponsors for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Sponsor Name

Sponsor Name for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Sponsor	Trials
University of Pennsylvania	2
Prince of Songkla University	1
University of Virginia	1

Sponsor Type

Sponsor Type for ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Sponsor	Trials
Other	10
Industry	2

Ondansetron Hydrochloride Preservative Free: Clinical Trials, Market Analysis, and Projections

Clinical Efficacy and Trials

Ondansetron hydrochloride, a widely used antiemetic, has been extensively studied in various clinical trials to assess its efficacy in preventing nausea and vomiting in different patient populations.

Chemotherapy-Induced Nausea and Vomiting (CINV)

In clinical trials involving adults undergoing cancer chemotherapy, ondansetron hydrochloride has shown significant efficacy. A double-blind trial comparing different dosing regimens (0.015 mg/kg, 0.15 mg/kg, and 0.30 mg/kg) administered three times during chemotherapy found that the 0.15 mg/kg dosing regimen was more effective than the 0.015 mg/kg regimen, with no additional benefit observed at the 0.30 mg/kg dose[1].

For pediatric patients, several open-label and noncomparative trials have been conducted. In one trial involving 75 pediatric cancer patients aged 6 to 48 months, ondansetron administered intravenously in three doses of 0.15 mg/kg resulted in a complete response (no emetic episodes) in 56% of patients on Day 1[1].

Postoperative Nausea and Vomiting (PONV)

Ondansetron hydrochloride has also been evaluated for its effectiveness in preventing PONV. Two placebo-controlled trials involving 2,792 patients undergoing major abdominal or gynecological surgeries showed that a single 4 mg intravenous dose of ondansetron significantly reduced the incidence of emetic episodes compared to placebo. However, no additional benefit was observed with an 8 mg dose[1].

In pediatric patients undergoing general anesthesia, ondansetron was found to be significantly more effective than placebo in preventing nausea and vomiting. A single 0.1 mg/kg intravenous dose administered immediately prior to or following anesthesia induction reduced vomiting incidence from 28% in the placebo group to 11% in the ondansetron group[1].

Market Analysis

The market for ondansetron hydrochloride is robust and growing, driven by several key factors.

Market Size and Forecast

As of 2023, the ondansetron hydrochloride market was valued at $755.73 million and is projected to reach $1,229.64 million by 2031, growing at a CAGR of 6.26% from 2024 to 2031. This growth is largely driven by the increasing prevalence of CINV and PONV, particularly in North America, Europe, and the Asia-Pacific regions[2].

Market Segmentation

By Type

The market is segmented based on purity levels: 97%, 98%, and 99%. In 2023, the 97% purity segment accounted for the largest market share of 60.64%, valued at $459.73 million, and is projected to grow at a CAGR of 5.93% during the forecast period[2].

By Application

The market is segmented into ondansetron hydrochloride injection and oral capsules. The oral capsule segment dominated the market in 2023 with a share of 76.56%, valued at $578.60 million, and is expected to grow at a CAGR of 6.12%[2].

By End Use

The human segment accounted for the largest market share of 67.30% in 2023, valued at $508.58 million, and is projected to grow at a CAGR of 5.86%. The veterinary segment, though smaller, is expected to grow at a higher CAGR of 7.06%[2].

By Geography

North America held the largest market share in 2023, valued at $370.47 million, and is expected to grow at a CAGR of 5.95%. The Asia-Pacific region is the second-largest market and is projected to grow at a CAGR of 6.75%[2].

Market Drivers and Trends

Increasing Prevalence of CINV and PONV

The rising incidence of CINV and PONV among patients undergoing chemotherapy and surgeries is a significant driver for the ondansetron hydrochloride market. These conditions can be highly debilitating and necessitate effective antiemetic treatment[2].

Expanding Pediatric Sector

The pediatric sector is increasingly adopting ondansetron hydrochloride, particularly for children undergoing chemotherapy or surgeries. This segment is expected to contribute significantly to market growth[2].

Efforts to Enhance Formulations

There have been ongoing efforts to make ondansetron hydrochloride formulations more patient-friendly, which is expected to boost market acceptance and usage[2].

Price Reductions

Efforts to reduce the price of ondansetron hydrochloride have expanded its market in emerging economies, particularly in the Asia-Pacific region. Lower prices are anticipated to increase sales in these regions[2].

Competitive Landscape

The ondansetron hydrochloride market is competitive, with several manufacturers and distributors. The market report provides a comprehensive analysis of key segments, trends, drivers, restraints, and the competitive landscape, which are crucial for understanding the market dynamics and making informed business decisions[2][5].

Key Takeaways

• Clinical Efficacy: Ondansetron hydrochloride has demonstrated significant efficacy in preventing CINV and PONV across various patient populations.
• Market Growth: The market is projected to grow from $755.73 million in 2023 to $1,229.64 million by 2031, driven by increasing prevalence of CINV and PONV.
• Segmentation: The market is segmented by type, application, end use, and geography, with oral capsules and the human segment dominating.
• Drivers: Rising incidence of CINV and PONV, expanding pediatric sector, and price reductions are key drivers.
• Competitive Landscape: The market is competitive, with a comprehensive analysis of key segments and trends essential for business strategies.

FAQs

What is the primary use of ondansetron hydrochloride?

Ondansetron hydrochloride is primarily used to prevent nausea and vomiting induced by chemotherapy, radiation therapy, and surgery.

What are the common dosing regimens for ondansetron hydrochloride?

Common dosing regimens include intravenous doses of 0.15 mg/kg for adults and children, and oral doses ranging from 4 mg to 24 mg daily, depending on the specific indication and patient population[1].

How is the ondansetron hydrochloride market segmented?

The market is segmented by type (purity levels), application (injection and oral capsules), end use (human and veterinary), and geography (North America, Europe, Asia-Pacific, etc.)[2].

What are the key drivers of the ondansetron hydrochloride market?

Key drivers include the increasing prevalence of CINV and PONV, the expanding pediatric sector, efforts to enhance formulations, and price reductions in emerging economies[2].

What is the projected growth rate of the ondansetron hydrochloride market?

The market is projected to grow at a CAGR of 6.26% from 2024 to 2031[2].

Sources

1. Pfizer Medical Information: Ondansetron Injection, USP - VIAL Clinical Studies - US.
2. Verified Market Research: Ondansetron Hydrochloride (HMB) Market Size, Forecast.
3. Science.gov: Trial comparing ondansetron: Topics by Science.gov.
4. FDA: Zofran - accessdata.fda.gov.
5. Cognitive Market Research: Global Ondansetron Hydrochloride Injection Market Report 2024 Edition.