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An Efficacy Study of JNJ-39220675 and Pseudoephedrine in Participants With Allergic Rhinitis

27 сентября 2013 г. обновлено: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Randomized, Single-Dose, Single-Blind, Double-Dummy, Placebo-Controlled, Three-Way Cross-Over Study to Compare the Relative Efficacy of JNJ-39220675, Pseudoephedrine and Placebo for the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Model

The purpose of this study is to evaluate the relative efficacy of JNJ- 39220675 and pseudoephedrine compared to placebo (medication with no active ingredients) in participants with allergic rhinitis (inflammation of the nose due to exposure to allergens such as pollen, dust or animal hair).

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

This is a randomized (the study drug is assigned by chance), single-dose, single-blind (a clinical trial in which the person giving the treatment, but not the participant, knows which treatment the participant is receiving), double-dummy, placebo-controlled, three-treatment period, cross-over (participants may receive different interventions sequentially during the trial) study of JNJ-39220675 in participants with allergic rhinitis. The duration of study will be 20-64 days per participant. The study consists of 2 parts: Screening (that is, 30 days before study commences on Day 1) and Treatment (consists of single-dose of either JNJ-39220675 solution [10 milligram], Pseudoephedrine tablet [60 milligram] or Placebo, in subsequent three-treatment periods, each separated with washout period of 6 days). All the eligible participants will be randomly assigned to 1 of the 6 treatment sequences. Participants will be given dose approximately 2 hours before entry into the environmental exposure chamber where they will be exposed to ragweed pollen for 8 hours. Efficacy will primarily be evaluated by measurement of nasal congestion that will be assessed through nasal cavity geometry that is, minimal cross-sectional area of nasal cavity by Acoustic rhinometry. Participants' safety will be monitored throughout the study.

Тип исследования

Интервенционный

Регистрация (Действительный)

53

Фаза

  • Фаза 2

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 65 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • Participants must have a clinical history of seasonal allergic rhinitis with seasonal onset and offset of nasal allergy symptoms at least during each of the last two ragweed allergy seasons
  • Participants must have documentation of a positive skin test within 12 months of Screening to ragweed allergen defined by a positive case history and a positive skin prick and/or intradermal test (allergy tests performed by injecting allergy-causing substances underneath the skin to see if they cause a reaction) for ragweed allergen
  • Female participants must not be pregnant, lactating or be able to become pregnant
  • Male participants must consent to use a medically acceptable method of contraception throughout the entire study period and for 3 months after the study is completed
  • Participants with body mass index between 18 and 32 kilogram per square meter

Exclusion Criteria:

  • Participants with clinically significant physical findings of nasal anatomical deformities
  • Participants with a history of risk factors for torsades de pointes (heart failure, hypokalemia, family history of long QT syndrome), use of concomitant medications that prolong the QT or QTc interval or an abnormal 12-lead electrocardiogram except for clinically non-significant bradycardia
  • Participants with history of exposure to an investigational treatment within the 30 days before the Screening Visit, or has ever taken JNJ-39220675 previously
  • Participants with a history of clinically significant allergies, especially known hypersensitivity or intolerance to any drug or known allergy to the study drug or any of the excipients of the formulation
  • Participants with a history of severe respiratory infection or disorder, epilepsy or seizures, coronary heart disease, uncontrolled hypertension, or other clinically significant cardiovascular disease, or history of a positive test for Human immuno-deficiency (HIV), Hepatitis B or Hepatitis C

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Назначение кроссовера
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: JNJ-39220675 then Pseudoephedrine then Placebo
Single-dose of JNJ-39220675 will be administered as 1 milliliter (ml) of 10 milligram/milliliter (mg/ml) solution orally along with placebo tablet in first treatment period; after that in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with 60 milligram (mg) pseudoephedrine tablet; and then single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.
Другой: Placebo
Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.
Лекарство: JNJ-39220675
Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
Лекарство: Pseudoephedrine
Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.
Экспериментальный: JNJ-39220675 then Placebo then Pseudoephedrine
Single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet in first treatment period; after that, in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with placebo tablet; and then single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.
Другой: Placebo
Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.
Лекарство: JNJ-39220675
Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
Лекарство: Pseudoephedrine
Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.
Экспериментальный: Placebo then JNJ-39220675 then Pseudoephedrine
Single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in first treatment period; after that, in second treatment period, single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet; and then single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.
Другой: Placebo
Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.
Лекарство: JNJ-39220675
Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
Лекарство: Pseudoephedrine
Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.
Экспериментальный: Placebo then Pseudoephedrine then JNJ-39220675
Single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in first treatment period; after that, in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet; and then single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.
Другой: Placebo
Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.
Лекарство: JNJ-39220675
Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
Лекарство: Pseudoephedrine
Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.
Экспериментальный: Pseudoephedrine then JNJ-39220675 then Placebo
Single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in first treatment period; after that, in second treatment period, single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution along with placebo tablet; and then single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.
Другой: Placebo
Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.
Лекарство: JNJ-39220675
Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
Лекарство: Pseudoephedrine
Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.
Экспериментальный: Pseudoephedrine then Placebo then JNJ-39220675
Single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in first treatment period; after that, in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with placebo tablet; and then single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.
Другой: Placebo
Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.
Лекарство: JNJ-39220675
Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
Лекарство: Pseudoephedrine
Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry
Временное ограничение: 2 and 0.5 hour before drug administration and 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period
The AcR was an objective measurement of nasal congestion that assessed nasal cavity geometry (that is, MCA) and changes in dimensions of nasal cavity. The AUC of MCA was used as response variable to assess treatment effect. AUC was adjusted for Baseline MCA scores. Baseline MCA was defined as minimum mean MCA at pre-dose (approximately 2 hours before Environmental Exposure Chamber [EEC] entry) resulting from 3 measurements on both, left and right nostrils in each of the treatment periods. The AUC of MCA was baseline-adjusted, by subtracting the Baseline value from each of the post-treatment times before calculating the AUC.
2 and 0.5 hour before drug administration and 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS)
Временное ограничение: 2, 1.5, 1, 0.5 hour before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period
The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. The AUC of TNSS was used as response variable to assess the treatment effect. AUC was adjusted for Baseline TNSS scores. Baseline TNSS was defined as the symptom scores for each treatment period at pre-dose (approximately 2 hour before EEC entry).
2, 1.5, 1, 0.5 hour before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period
Change From Baseline in Total Nasal Symptom Score (TNSS) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 Hours After Drug Administration at Day 1
Временное ограничение: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period
The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. Change from Baseline in TNSS is the value at particular time point minus value at Baseline.
0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period
Change From Baseline in Minimal Cross-Sectional Area (MCA) at 1, 2, 3, 4, 5, 6, 7 and 8 Hours After Drug Administration at Day 1
Временное ограничение: Baseline, 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period
The MCA was measured using AcR which is an objective measurement of nasal congestion that assesses nasal cavity geometry (that is, MCA) and changes in the dimensions of the nasal cavity. Change from Baseline in MCA is the value at particular time point minus value at Baseline.
Baseline, 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Следователи

  • Директор по исследованиям: Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 ноября 2008 г.

Первичное завершение (Действительный)

1 февраля 2009 г.

Завершение исследования (Действительный)

1 февраля 2009 г.

Даты регистрации исследования

Первый отправленный

8 декабря 2008 г.

Впервые представлено, что соответствует критериям контроля качества

8 декабря 2008 г.

Первый опубликованный (Оценивать)

9 декабря 2008 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

30 октября 2013 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

27 сентября 2013 г.

Последняя проверка

1 сентября 2013 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • CR015709
  • 39220675ATT2001

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Placebo

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