A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain
2020년 4월 13일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
26
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ohio
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Centerville, Ohio, 미국, 45458
- Ohio Pain Clinic
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 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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활성 비교기: 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
다른 이름들:
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위약 비교기: 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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활성 비교기: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Reporting of Adverse Events During 12 Week Study Period
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pharmacokinetics (Blood Levels of Nitrite)
기간: 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.
기간: 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.
기간: 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)
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2015년 4월 28일
기본 완료 (실제)
2015년 12월 7일
연구 완료 (실제)
2017년 4월 3일
연구 등록 날짜
최초 제출
2015년 4월 1일
QC 기준을 충족하는 최초 제출
2015년 4월 8일
처음 게시됨 (추정)
2015년 4월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 4월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 4월 13일
마지막으로 확인됨
2020년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- TheraVasc-TV1001-003
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니
IPD 계획 설명
IPD will only be available to the PI of the trial, summary information will be published and shared with other researchers.
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Placebo에 대한 임상 시험
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AJU Pharm Co., Ltd.OM Pharma SA모병
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University Hospital, Strasbourg, France모집하지 않고 적극적으로