Effect of Azithromycin on Oesophageal Hypomotility
Recruitment status was Not yet recruiting
|First Received Date ICMJE||September 30, 2011|
|Last Updated Date||October 9, 2011|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Effect of Azithromycin on oesophageal peristalstic contraction amplitude in patients with hypomotility [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The amplitude of peristaltic contractions and also Distal Contractal Integral which summarises the vigour of peristalsis will be measured before and after treatment with Azithromycin. Measurement is performed by oesophageal high resolution manometry. The measures will be compared to decide on the effect oo Azithromycin on oesophageal motility.
|Original Primary Outcome Measures ICMJE
||Effect of Azithromycin on oesophageal hypomotility|
|Change History||Complete list of historical versions of study NCT01448993 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Manometric oesophageal body response (amplitude of peristaltic contractions in mmHg and also Distal Contractal Integral in mmHg.cm.second) to solid bolus swallows, MRS and outlet obstruction in healthy subjects and patients with oesophageal hypomotility. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The above parameters will be measured before and after treatment with Azithromycin. Measurement is performed by oesophageal high resolution manometry. The measures will be compared to decide on the effect oo Azithromycin on oesophageal motility.
|Original Secondary Outcome Measures ICMJE
||Manometric oesophageal body response to solid bolus swallows, MRS and outlet obstruction in healthy subjects and patients with oesophageal hypomotility.|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effect of Azithromycin on Oesophageal Hypomotility|
|Official Title ICMJE||Effect Of Azithromycin On Oesophageal Function In Patients With Dysphagia Or Gastro-Oesophageal Reflux Associated With Frequent Oesophageal Hypomotility|
Patients with difficulty in swallowing (dysphagia) or with reflux disease are frequently found to suffer from oesophageal hypomotility (weak contractions).
Oesophageal motility is currently measured using high-resolution manometry (HRM). This technique has a 36 pressure sensors on a plastic tube to record the pressure in side the oesophagus.
Several pharmaceutical agents (prokinetics) can stimulate oesophageal motility. However, use of prokinetics in patients with oesophageal hypomotility led to disappointing results. An explanation for these disappointing results is that inappropriate patients were targeted. The appropriate patient would be the one who still have some viable muscle in the oesophagus that can respond to pharmacological stimuli.
In the process of developing treatment strategies in patients with oesophageal hypomotility, testing the preserved capacity of oesophageal muscles could be useful to predict the response of these patients to prokinetic drugs. The following tests have the potential to reveal the preserved capacity of the oesophageal muscle to respond to stronger/medicinal stimuli.
The purpose of the proposed project is to firstly assess the effect of Azithromycin on oesophageal hypomotility and secondly to evaluate the predictive values of the stimulation techniques in predicting the likelihood the positive response to drug therapy.
|Detailed Description||Not Provided|
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Condition ICMJE||Esophageal Motility Disorders|
|Study Arm (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||34|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 70 Years|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United Kingdom|
|NCT Number ICMJE||NCT01448993|
|Other Study ID Numbers ICMJE||BICMS/PR/11/127|
|Has Data Monitoring Committee||Yes|
|Responsible Party||JAFAR JAFARI, Queen Mary University of London|
|Study Sponsor ICMJE||JAFAR JAFARI|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||Queen Mary University of London|
|Verification Date||October 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP