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Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia

This study has been terminated.
(Not enough participants - only 5 since the study started)
Sponsor:
Information provided by (Responsible Party):
Fernando Castro, Cleveland Clinic Florida
ClinicalTrials.gov Identifier:
NCT00547703
First received: October 19, 2007
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
Results First Received: February 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Non Ulcer Dyspepsia
Interventions: Drug: Nortriptyline
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Nortriptyline Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
Placebo Patients in this group will receive an identical placebo capsule at night for 8 weeks.

Participant Flow:   Overall Study
    Nortriptyline     Placebo  
STARTED     4     1  
COMPLETED     3     1  
NOT COMPLETED     1     0  
Lost to Follow-up                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Nortriptyline Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
Placebo Patients in this group will receive an identical placebo capsule at night for 8 weeks.
Total Total of all reporting groups

Baseline Measures
    Nortriptyline     Placebo     Total  
Number of Participants  
[units: participants]
 		  4     1     5  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     4     1     5  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  42  ± 4     43  ± 0     42  ± 4  
Gender  
[units: participants]
 		     
Female     1     1     2  
Male     3     0     3  
Region of Enrollment  
[units: participants]
 		     
United States     4     1     5  



  Outcome Measures

1.  Primary:   Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer.   [ Time Frame: 8 weeks ]
  Show Outcome Measure 1

2.  Secondary:   QOLRAD Questionaire for Patients With Upper Abdominal Symptoms   [ Time Frame: 8 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Side Effects   [ Time Frame: 8 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
We were unable to recruit an adequate number of patients to make any meaningful conclusion.  


Results Point of Contact:  
Name/Title: Fernando Castro
Organization: Cleveland Clinic Florida
phone: 954-659-5646
e-mail: castrof@ccf.org


Publications:


Responsible Party: Fernando Castro, Cleveland Clinic Florida
ClinicalTrials.gov Identifier: NCT00547703     History of Changes
Other Study ID Numbers: IRB 8918
Study First Received: October 19, 2007
Results First Received: February 20, 2012
Last Updated: June 7, 2012
Health Authority: United States: Institutional Review Board