A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain
2020年4月13日 更新者：TheraVasc Inc.
A Randomized, Double-blinded, Phase 2a Study to Assess the Safety and Pharmacokinetics of a Sustained Release Formulation of Sodium Nitrite (TV1001sr) in Patients With Diabetic Neuropathic Pain (DNP)
In this study, subjects with diabetic neuropathic pain (DNP) will be treated for 12 weeks with either placebo, 40 or 80 mg sustained release sodium nitrite (TV1001sr) twice daily.
Primary endpoints will be safety and pharmacokinetics.
Assessment of the study medications affects on pain following treatment will also be recorded.
調査の概要
詳細な説明
This is a dose-ranging study to evaluate the safety, pharmacokinetics, and tolerability of multiple doses of an oral, sustained release formulation of sodium nitrite (TV1001sr) in subjects with DNP.
The primary objective is to assess the safety and tolerability of multiple doses of twice daily 40 mg and 80 mg TV1001sr compared with placebo over a 12 week treatment period and the pharmacokinetics of the sustained release formulation of sodium nitrite.
Secondary objectives are to evaluate the pharmacokinetics and markers of functional improvement including pain questionnaires, quantitative sensory testing and changes in markers of diabetes.
研究の種類
介入
入学 (実際)
26
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ohio
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Centerville、Ohio、アメリカ、45458
- Ohio Pain Clinic
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Female subjects must be post-menopausal, sterilized or using suitable birth control
- Diagnosis of diabetes (HbA1c > 6.0)
- Diagnosis of diabetic peripheral neuropathy pain in feet
- Presence of ongoing diabetic neuropathic for at least 3 months
- A pain score of greater than or equal to 4 on the Numerical Pain Rating Scale at screening
- Ability to provide written informed consent
Exclusion Criteria:
- Patients with fibromyalgia or regional pain caused by lumbar or cervical compression
- History or diagnosis of significant neurological disease
- History and diagnosis of clinically significant psychiatric diseases
- Serious liver disease
- Poorly controlled diabetes
- Hypersensitivity to sodium nitrite or related compounds
- Life expectancy < 6 months
- A chronic illness that may increase the risks associated with this study
- Active malignancy requiring active anti-neoplastic therapy that will, in the opinion of the investigator, interfere with study treatment or participation
- Pregnant or nursing women
- Current diagnosis of alcohol or other substance abuse
- Current use of sildenafil or other phosphodiesterase Type 5 Inhibitors
- History of methemoglobinemia, (met-Hb ≥ 15%)
- Subject is involved in litigation or receives worker's compensation
- Inability to speak English
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター：Placebo
One placebo tablet administered twice daily for 12 weeks.
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Placebo tablets containing same excipients and coatings used in the active tablets, without sodium nitrite being added.
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アクティブコンパレータ：40 mg TV1001sr
One 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
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Sustained release formulation of sodium nitrite
他の名前：
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プラセボコンパレーター：Placebo (2)
Two placebo tablets administered twice daily for 12 weeks.
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Placebo tablets containing same excipients and coatings used in the active tablets, without sodium nitrite being added.
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アクティブコンパレータ：80 mg TV1001sr
Two 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
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Sustained release formulation of sodium nitrite
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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Reporting of Adverse Events During 12 Week Study Period
時間枠：12 weeks
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The primary objective of this clinical study is to evaluate the safety and tolerability of multiple doses of twice daily 40mg and 80mg sustained release sodium nitrite compared with placebo over a 12 week treatment period.
The following safety parameters will also be assessed: concomitant medication usage, physical examination, vital signs, Comprehensive Metabolic Panel, and complete blood count.
Assessment of acute adverse events (i.e., drop in blood pressure, dizziness) after administration of each dose level.
Counts are number of subjects reporting at least 1 Adverse Event.
The total Adverse Events recorded in each cohort is also reported.
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12 weeks
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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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Pharmacokinetics (Blood Levels of Nitrite)
時間枠：1 day
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Blood levels of nitrite will be assessed for 6 hours post-administration on the initial dosing visit.
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1 day
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The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.
時間枠：12 weeks
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Daily patient reported use of analgesic or medications for neuropathic pain.
The use of medications were recorded at the baseline visit and during both the intermediate and final visit for each subject.
All subjects used at least one prescription pain medication, other than one subject in the 80-mg dose cohort who used only ibuprofen to control pain.
Most subjects used more than one prescription pain medication.
There was no change in use of pain medications during the trial period.
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12 weeks
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Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.
時間枠：Baseline (visit 1) and 12 weeks (visit 3)
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Subjects completed the Brief pain inventory (BPI), RAND 36 questionnaire, neuropathic pain symptom inventory (NPSI) and Short Form McGill Pain Questionnaire at each visit for these self-reported questionnaires.
The BPI is a questionnaire that measures the patient's subjective perception of pain, its exacerbating and alleviating factors, and perceived effect on functional status; the NPSI is a questionnaire that measures the symptoms associated with neuropathic pain; the Short Form McGill Questionnaire subjectively assesses the patients perception of pain described by commonly used adjectives associated with pain.
NPSI is average of 12 questions, range from 0 (no pain) to 120 (maximal pain); For BPI severity and interference, questions are scored from 0-10, then there average score for each subsection is calculated (the higher the score, the worse the response); Scores on McGill range from 0-10, lower associated for less pain, then averaged for each sub score and total score.
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Baseline (visit 1) and 12 weeks (visit 3)
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Clinical Assessment of Pain. (Quantitative Sensory Testing)
時間枠：12 weeks
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Quantitative sensory testing (QST) was conducted at each visit to determine patients sensitivity to pain.
QST was assessed using a quantitative nerve conductance machine where nerves in the distal extremity are subjected to electrical stimulation to determine the sensory threshold of the skin.
Nerve conductance measures how fast an electrical impulse moves through the nerve, and nerve velocity measures the speed at which an electrical impulse moves down a neuronal pathway.
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12 weeks
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Assessment of Diabetes. (HbA1C Levels)
時間枠：12 weeks
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HbA1C levels will be monitored at each visit to determine whether treatment reduces circulating glucose levels.
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12 weeks
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Assessment of Blood Oxygenation. (Pulse Oximetry)
時間枠：12 weeks
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Pulse oximetry will be used at each visit to determine whether treatment improves oxygen levels in the blood.
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12 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2015年4月28日
一次修了 (実際)
2015年12月7日
研究の完了 (実際)
2017年4月3日
試験登録日
最初に提出
2015年4月1日
QC基準を満たした最初の提出物
2015年4月8日
最初の投稿 (見積もり)
2015年4月9日
学習記録の更新
投稿された最後の更新 (実際)
2020年4月24日
QC基準を満たした最後の更新が送信されました
2020年4月13日
最終確認日
2020年4月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- TheraVasc-TV1001-003
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
IPD will only be available to the PI of the trial, summary information will be published and shared with other researchers.
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Placeboの臨床試験
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Shanghai Hengrui Pharmaceutical Co., Ltd.完了
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Palacky University完了
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Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了