AZ Delta
Roeselare, Belgium
NCT Number: NCT06356025
The aim of this study is to assess the effect of botulinum toxin injection into the upper esophageal sphincter in a double blind, placebo controlled study. Investigators want to assess the effect on symptoms short term (1-20 weeks after BT injection), and long term (48 weeks after BT injection).
This is a prospective double-blind randomized placebo-controlled study. Questionnaires assessing symptoms will be filled out on several occasions. At 20 weeks, a reassessment of symptoms will be done, without unblinding patients or investigator. Failures (to BT or placebo, defined as no clinical improvement or improvement less than 50%) will get the chance to receive a second procedure with active treatment (BT) in open label.
This study is active but is not currently recruiting participants.
Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Roeselare, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Participants eligible for inclusion in this Trial must meet all of the following criteria:
Participants eligible for this Trial must not meet any of the following criteria:
Botulinum toxin type A 75U dissolved in 3mL physiological serum injection in the upper esophageal sphincter
Placebo: physiological serum 3mL injection in the upper esophageal sphincter
Time frame: week 12
This questionnaire is a treatment effect measure specific for inability to belch, where the change in symptoms from baseline is assessed, on a scale from 0% to 100%. 100% means complete resolution of symptoms, 0% means no improvement.
Time frame: 48 weeks
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?'.
Time frame: 4 weeks
Safety: assessed by the number and type of (serious) adverse events that occurred in each group by week 48
Time frame: 4 weeks
assessed by the Sydney Swallow Questionnaire 1 week and 4 weeks after the procedure.
Time frame: 1 to 48 weeks
HRQOL using EQ-5D VAS score short-term (1, 4,12 weeks) and long-term (20 - 48 weeks after the procedure).
Time frame: 1-48 weeks
Patients experience and satisfaction of the treatment based on OTE short-term (1, 4, 12 weeks after the procedure), and long-term (20 - 48 weeks after the procedure) OTE is an outcome measure with 9 choices: going from -4: it has become insupportable, in the middle 0: unchanged, and at the end +4: the symptoms have completely resolved.
Time frame: 1-48 weeks
Patients experience and satisfaction of the treatment based on OSS short-term (1, 4, 12 weeks after the procedure), and long-term (20 - 48 weeks after the procedure)
Time frame: 1-48 weeks
Evolution of associated abdominal bloating short-term (1, 4, 12 weeks) and long-term (20 - 48 weeks after the procedure).
Time frame: 1-48 weeks
Evolution of associated abdominal/thoracic pain short-term (1, 4, 12 weeks) and long-term (20 - 48 weeks after the procedure).
Time frame: 1-48 weeks
Evolution of associated flatulence short-term (1, 4, 12 weeks) and long-term (20 - 48 weeks after the procedure).
Time frame: 1-48 weeks
Evolution of associated gurgling noises short-term (1, 4, 12 weeks) and long-term (20 - 48 weeks after the procedure).
Time frame: 12-48 weeks
Safety during follow-up, with SSQ at week 12, 20 and 48.
Time frame: 20 weeks
Change in objective measurements after, versus before BT injeciton using high resolution impedance manometry at week 20, and comparing with baseline.
Time frame: 20 weeks
Change in objective measurements after, versus before BT injeciton using high resolution impedance manometry at week 20, and comparing with baseline.
Time frame: 48 weeks
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?'.
AZ Delta
Other
Botulinum Toxin Injection in the Upper Esophageal Sphincter for Retrograde-cricopharyngeus Dysfunction: a Prospective, Double Blind, Placebo-controlled Trial
Acronym: BOTUS R-CPD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.