2024-512546-42-00招募中4 期
Botulinum toxin injection in the upper esophageal sphincter for retrograde-cricopharyngeus dysfunction: a double blind, placebo-controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Response to Botox versus placebo, 12 weeks after treatment. We will use the questionnaire of ‘Difficulties with belching’, and response is defined as at least a 50% improvement on question 6A ‘To what extent have the symptoms of 'difficulty burping air' been reduced after treatment?'.
研究概览
简要总结
to assess the effect of botulinum toxin injection into the upper esophageal sphincter on the symptoms of ‘inability to belch’ 12 weeks after the injection in a double blind, placebo controlled study.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- •Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
- •Between 18 and 65 years old
- •Inability to belch, which is bothersome enough to consider treatment*, present for at least 6 months prior to inclusion, and in fulfillment of both categories a and b below:, a. presence of associated gastrointestinal symptoms such as abdominal bloating and discomfort/nausea, flatulence, gurgling noises from the chest or lower neck. b. Absence of other pharyngeal and esophageal pathologies, determined on the basis of history taking and diagnostic tests. * Bothersome = severe enough to impact on usual activities, according to the Rome IV diagnostic criteria
- •Typical findings on high resolution impedance manometry with belch provocation test (10). These typical findings include: No relaxation upon gastroesophageal gas reflux, no air clearance via the UES but instead an increased air presence time include air entrapment and oscillations.
排除标准
- •Participant has a history of surgery in the upper GI tract, that might interfere with the belch reflex (such as anti-reflux surgery)
- •Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
- •Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial, to be decided at the discretion of the investigator.
- •If applicable: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
- •Participation in another interventional Trial with an investigational medicinal product (IMP) or device
- •>65 years old; < 18 years of age
- •Known hypersensitivity to botulinum toxin type A or to human albumin or sodium chloride.
- •Presence of infection at the proposed injection site(s).
结局指标
主要结局
Response to Botox versus placebo, 12 weeks after treatment. We will use the questionnaire of ‘Difficulties with belching’, and response is defined as at least a 50% improvement on question 6A ‘To what extent have the symptoms of 'difficulty burping air' been reduced after treatment?'.
Response to Botox versus placebo, 12 weeks after treatment. We will use the questionnaire of ‘Difficulties with belching’, and response is defined as at least a 50% improvement on question 6A ‘To what extent have the symptoms of 'difficulty burping air' been reduced after treatment?'.
次要结局
- Response to Botox versus placebo, 48 weeks after treatment. We will use the questionnaire of ‘Difficulties with belching’, and response is defined as at least a 50% improvement on question 6A ‘To what extent have the symptoms of 'difficulty burping air' been reduced after treatment?'.
- Safety: assessed by the number and type of (serious) adverse events that occurred in each group by week 48, and by the SSQ 1 week and 4 weeks after the procedure.
- Exploratory: HRQOL using EQ-5D VAS score short-term (1, 4, 12 weeks) and long-term (30 - 48 weeks after the procedure).
- Exploratory: Patients experience and satisfaction of the treatment based on OTE and OSS short-term (1, 4, 12 weeks after the procedure), and long-term (20 - 48 weeks after the procedure)
- Exploratory: Evolution of associated gastro-intestinal symptoms short-term (1, 4, 12 weeks) and long-term (20 - 48 weeks after the procedure).
- Exploratory: Change in objective measurements after, versus before BT injeciton using high resolution impedance manometry at week 20, and comparing with baseline.
- Exploratory: Improvement in symptoms after Botox versus placebo, 12 and 48 weeks after treatment. We will use the questionnaire of ‘Difficulties with belching’, using a cut-off for improvement of 30% on question 6A ‘To what extent have the symptoms of 'difficulty burping air' been reduced after treatment?'.
- Exploratory: Safety at week 12, 20 and 48 using SSQ
研究者
K.G. Delsupehe
Scientific
Algemeen Ziekenhuis Delta
研究点 (1)
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