Trial Outcomes & Findings for Response to Supplement and Placebo in GERD (NCT NCT01915173)

NCT ID: NCT01915173

Last Updated: 2017-03-29

Results Overview

Serious adverse events (as defined by the FDA) are events that are potentially life-threatening or result in death, hospitalization, an emergency room visit, disability or permanent damage, a congenital abnormality, require intervention to prevent permanent impairment, or seriously jeopardizes a patient's health.

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

2 week follow-up

Results posted on

2017-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	Supplement + Expanded Interview Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C Expanded Interview	Placebo + Standard Interview Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Standard Interview	Supplement + Standard Interview Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C Standard Interview	Placebo + Expanded Interview Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Expanded Interview
Overall Study STARTED	6	6	6	6
Overall Study COMPLETED	6	6	6	6
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Response to Supplement and Placebo in GERD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo + Standard Interview n=6 Participants Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Standard Interview	Supplement + Standard Interview n=6 Participants Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C Standard Interview	Placebo + Expanded Interview n=6 Participants Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Expanded Interview	Supplement + Expanded Interview n=6 Participants Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C Expanded Interview	Total n=24 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	17 Participants n=21 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Age, Continuous	60 years STANDARD_DEVIATION 14 • n=5 Participants	64 years STANDARD_DEVIATION 6.3 • n=7 Participants	54 years STANDARD_DEVIATION 9.9 • n=5 Participants	53 years STANDARD_DEVIATION 12 • n=4 Participants	58 years STANDARD_DEVIATION 11 • n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	16 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	23 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
GERD symptom severity	4.2 scores on a scale STANDARD_DEVIATION 2.1 • n=5 Participants	5.6 scores on a scale STANDARD_DEVIATION 2.6 • n=7 Participants	3.6 scores on a scale STANDARD_DEVIATION 2.2 • n=5 Participants	3.8 scores on a scale STANDARD_DEVIATION 2.3 • n=4 Participants	4.3 scores on a scale STANDARD_DEVIATION 2.3 • n=21 Participants

PRIMARY outcome

Timeframe: 2 week follow-up

Population: All enrolled study participants.

Outcome measures

Outcome measures
Measure	Placebo + Standard Interview n=6 Participants Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Standard Interview	Supplement + Standard Interview n=6 Participants Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C Standard Interview	Placebo + Expanded Interview n=6 Participants Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Expanded Interview	Supplement + Expanded Interview n=6 Participants Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C Expanded Interview
Safety - Number of Participants Experiencing a Serious Adverse Event	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Second week of the trial compared to pre-trial baseline

Population: All enrolled study participants.

Average daily GERD symptom severity during the last 7 days of the study was compared to average daily GERD symptom severity at baseline using daily study diary entries. GERD symptom severity for each day was based on the sum of scores assessing the severity of daytime heartburn, nighttime heartburn, and acid reflux each on a 0-4 point scale (none, mild, moderate, severe, very severe). Higher scores signify worse symptoms. The number of subjects with a 50% or greater decrease in GERD symptom severity from baseline to end of study in each group was calculated.

Outcome measures

Outcome measures
Measure	Placebo + Standard Interview n=6 Participants Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Standard Interview	Supplement + Standard Interview n=6 Participants Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C Standard Interview	Placebo + Expanded Interview n=6 Participants Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Expanded Interview	Supplement + Expanded Interview n=6 Participants Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C Expanded Interview
Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity	2 participants	0 participants	5 participants	4 participants

SECONDARY outcome

Timeframe: Two weeks

Population: All enrolled study participants.

The GERD Health-Related Quality of Life (GERD-HRQL) scale is a validated instrument assessing GERD-specific health-related quality of life using 10 questions, each on a 0-5 point scale. Scale range is 0-50 with higher numbers signifying worse quality of life.

Outcome measures

Outcome measures
Measure	Placebo + Standard Interview n=6 Participants Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Standard Interview	Supplement + Standard Interview n=6 Participants Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C Standard Interview	Placebo + Expanded Interview n=6 Participants Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Expanded Interview	Supplement + Expanded Interview n=6 Participants Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C Expanded Interview
GERD Health-Related Quality of Life at Follow-up	18.2 units on a scale Standard Deviation 4.5	26.3 units on a scale Standard Deviation 7.8	17.7 units on a scale Standard Deviation 3.4	18.3 units on a scale Standard Deviation 4.9

Adverse Events

Placebo + Standard Interview

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Supplement + Standard Interview

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo + Expanded Interview

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Supplement + Expanded Interview

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Michelle L. Dossett, MD, PhD, MPH

Massachusetts General Hospital

Phone: 617-643-6034

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo + Standard Interview n=6 participants at risk Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Standard Interview	Supplement + Standard Interview n=6 participants at risk Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C Standard Interview	Placebo + Expanded Interview n=6 participants at risk Placebo, 2 tablets sublingually 3 times a day for 2 weeks. Placebo: Lactose tablets Expanded Interview	Supplement + Expanded Interview n=6 participants at risk Supplement, 2 tablets sublingually 3 times a day for 2 weeks. Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C Expanded Interview
Gastrointestinal disorders Cramping or abdominal discomfort	33.3% 2/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.
Gastrointestinal disorders Diarrhea or loose stools	33.3% 2/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.
Gastrointestinal disorders Constipation	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.
Gastrointestinal disorders Heartburn	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.	33.3% 2/6 • 2 weeks Data collected from subject symptom diaries.	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.
Gastrointestinal disorders Flatulence	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.
Gastrointestinal disorders Burping	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.
Nervous system disorders Headache	33.3% 2/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	33.3% 2/6 • 2 weeks Data collected from subject symptom diaries.
Respiratory, thoracic and mediastinal disorders Cough or congestion	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.
Gastrointestinal disorders Nausea and/or vomiting	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.
Respiratory, thoracic and mediastinal disorders Throat or mouth discomfort	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.
General disorders Sweating	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.
General disorders Fatigue	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.
Gastrointestinal disorders Bright red blood per rectum	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.
Cardiac disorders Chest pain	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.
Psychiatric disorders Anxiety	16.7% 1/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.	0.00% 0/6 • 2 weeks Data collected from subject symptom diaries.