An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain (Palladone)
A Multi-center, Open-label, Dose Titration Study Pharmacokinetics/Pharmacodynamics, Safety, and Efficacy of Hydromorphone Oral Solution in Subjects From 28 Days to 16 Years of Age, Who Require Opioid Analgesics for Postoperative Pain
調査の概要
詳細な説明
Hydromorphone is an opioid analgesic that has been used for decades as an alternative to morphine in the treatment of moderate to severe malignant and nonmalignant pain. Only a small number of analgesics have been studied in children. The benefits to the subjects include contribution of knowledge that will provide for appropriate dosing regimen recommendations for future pediatric subjects.
Treatment consisted of both parenteral and oral hydromorphone. For up to 48 hours immediately following surgery, subjects were administered hydromorphone by IV PCA pump. Dosing with the oral hydromorphone HCl began when the subject was ready to take clear oral liquid. Subjects were administered oral hydromorphone HCl every 6 hours for up to 9 doses. The investigator determined the timing of the first dose based on each subject's clinical condition.
The duration of the treatment phase was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period).
Efficacy was based on the oral hydromorphone treatment. Adverse events were collected for both the oral and parenteral treatments.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Arkansas
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Little Rock、Arkansas、アメリカ、72202
- Arkansas Children's Hospital
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California
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Orange、California、アメリカ、92868
- Children's Hospital of Orange County - Pediatric Subspecialty
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Stanford、California、アメリカ、94305
- Stanford University Medical Center
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Colorado
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Aurora、Colorado、アメリカ、80218
- The Children's Hospital
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Connecticut
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New Haven、Connecticut、アメリカ、06510
- Yale-New Haven Children's Hospital
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Florida
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Miami、Florida、アメリカ、33136
- Jackson Memorial Hospital
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Iowa
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Iowa City、Iowa、アメリカ、52242
- University of Iowa Hospitals and Clinics
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Missouri
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St. Louis、Missouri、アメリカ、63104
- Saint Louis University - Department of Neurology and Psychiatry
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599-7221
- The University of North Carolina - CH
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Durham、North Carolina、アメリカ、27710
- Duke University Medical Center
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Ohio
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Akron、Ohio、アメリカ、44308
- Children's Hospital Medical Center of Akron
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Texas
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Dallas、Texas、アメリカ、75235
- Children's Medical Center
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Houston、Texas、アメリカ、77030
- Texas Children's Hospital / Baylor College of Medicine
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Houston、Texas、アメリカ、77030
- The University of Texas, Health Sciences Center at Houston
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Pediatric subjects aged 28 days to 16 years,
- Prospective subjects anticipated to have postoperative pain requiring oral opioid analgesics for at least 24 hours (up to 48 hours) following postoperative parenteral analgesia (up to 48 hours),
- Prospective subjects have received no more than a total of 7 doses of opioids in the 30 days prior to surgery.
Exclusion Criteria:
- Prospective subjects with clinically significant hepatic or renal dysfunction and impaired cardiac and/or respiratory reserve,
- Prospective subjects who have received opioid analgesic therapy other than hydromorphone or morphine sulfate during the up to 48-hour postoperative period prior to administration of first dose of oral hydromorphone,
- Prospective subjects who have received regional anesthetic blockade OR analgesic treatment with nonopioid medication within 6 hours prior to administration of first dose of oral hydromorphone.
Other protocol-specific inclusion/exclusion criteria may apply.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：≥ 28 Days to < 13 Months
infant and toddler
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Oral hydromorphone solution dosed every 6 hours up to 9 doses.
Dose is determined based on the expected weight range for each age group.
他の名前：
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実験的：≥ 13 months to < 5 years
young child
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Oral hydromorphone solution dosed every 6 hours up to 9 doses.
Dose is determined based on the expected weight range for each age group.
他の名前：
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実験的：≥ 5 years to < 12 years
older child
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Oral hydromorphone solution dosed every 6 hours up to 9 doses.
Dose is determined based on the expected weight range for each age group.
他の名前：
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実験的：≥ 12 years to < 17 years
adolescent
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Oral hydromorphone solution dosed every 6 hours up to 9 doses.
Dose is determined based on the expected weight range for each age group.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl)
時間枠：A maximum of 9 oral hydromorphone doses with potentially up to 54 hours duration.
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Model was built using sparse blood samples: Sampling times: immediately predose, and between 0.25-0.75, 1-3, and 4-6 hours postdose for the first 2 doses of oral hydromorphone: predose for each dose of oral hydromorphone HCl thereafter; and at the end of study. Efficacy was based on Oral treatment only. |
A maximum of 9 oral hydromorphone doses with potentially up to 54 hours duration.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years]
時間枠：Immediately prior to first oral dose, up to 54 hours
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There are 5 categories in this pediatric pain measurement: face, legs, activity, cry, and consolability.
Responses in each category are scored between 0 and 2 (0 = normal, relaxed to 2 = upset, agitated), for a maximum total score of 10.
The FLACC scale was used for children under the age of 3 years and older children who have limited verbal skills.
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Immediately prior to first oral dose, up to 54 hours
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Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time
時間枠：Immediately prior to first oral dose with potentially up to 54 hours duration.
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Faces Pain Scale-Revised (FPS-R) consists of 6 facial expressions.
Each face is 25 x 35 mm with 13 mm between faces.
Each subject was asked to point to the face that reflected his or her pain.
The end points are 0 = no pain and 10 = very much pain.
The FPS-R scale was used for children over the age of 5 up to 12 years who have appropriate verbal skills.
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Immediately prior to first oral dose with potentially up to 54 hours duration.
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Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time
時間枠：Immediately prior to first oral dose, up to 54 hours
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The Visual Analog Scale (VAS), a 10-cm Color Analog Scale anchored by the descriptors of 0 = "no pain" and 10 = "most pain," was used by children ≥ 12 years of age.
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Immediately prior to first oral dose, up to 54 hours
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Gregory B. Hammer, MD、Stanford University
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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術後の痛みの臨床試験
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Dexa Medica Group完了
Hydromorphoneの臨床試験
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Alza Corporation, DE, USA完了