Trial Outcomes & Findings for Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia (NCT NCT00547703)

Results Overview

Patient would answer yes or no to a simple question asking whether they had adequate relief of abdominal pain or discomfort. This was measured at weeks 2,4 and 8 of the study but only week 8 was reported. What is being reported is the number of participants who answered yes.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-05-17

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	4	1
Overall Study COMPLETED	3	1
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nortriptyline n=4 Participants Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.	Placebo n=1 Participants Patients in this group will receive an identical placebo capsule at night for 8 weeks.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	42 years STANDARD_DEVIATION 4 • n=5 Participants	43 years STANDARD_DEVIATION 0 • n=7 Participants	42 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: All patients who completed the 8 weeks of the study

Patient would answer yes or no to a simple question asking whether they had adequate relief of abdominal pain or discomfort. This was measured at weeks 2,4 and 8 of the study but only week 8 was reported. What is being reported is the number of participants who answered yes.

Outcome measures

Outcome measures
Measure	Nortriptyline n=3 Participants Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.	Placebo n=1 Participants Patients in this group will receive an identical placebo capsule at night for 8 weeks.
Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer.	2 participants	1 participants

SECONDARY outcome

Timeframe: 8 weeks

Patients were administered the validated QOLRAD questionnaire on quality of life to assess if nortriptyline improves quality of life in patients with nonulcer dyspepsia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

To assess frequency of side effects in patients receiving Nortriptyline for nonulcer dyspepsia. Patients were asked about side effects on each office visit and ask to call for significant side effects.

Outcome measures

Outcome data not reported

Adverse Events

Nortriptyline

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nortriptyline n=3 participants at risk Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.	Placebo n=1 participants at risk Patients in this group will receive an identical placebo capsule at night for 8 weeks.
Gastrointestinal disorders Constipation	66.7% 2/3 • Number of events 2	100.0% 1/1 • Number of events 1

Additional Information

Fernando Castro

Cleveland Clinic Florida

Phone: 954-659-5646

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place