Trial Outcomes & Findings for Pregabalin for Abdominal Pain From Adhesions (NCT NCT00310765)

Last Updated: 2023-10-23

Results Overview

Patients were randomized to pregabalin or placebo 75 mg twice a day. Patients were allowed to double the dose on day 3 if adequate pain relief was not obtained. Abdominal pain reduction was measured on a Likert scale. A Likert scale assumes the intensity of pain is linear on a continuum from no pain at level 0 to severe pain at level 10. Patients were required to complete a daily dairy recording pain using the Likert 11-point numeric scale. The primary end point was a positive change in the daily pain diary of 2 points from each patient's baseline at weeks 8 after the completion of the blinded study and at week 12 during the open label portion of the study. After 7 weeks all patients are randomized to study drug pregabalin 150 to 300 mg daily for 4 additional weeks after a one week wash out with no medication.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

18 participants

Primary outcome timeframe

Baseline and week 2 through week 12

Results posted on

2023-10-23

Participant Flow

Study was performed between December 2005 and August 2008. Patients were referred to the gastroenterology clinic if they had documented adhesions in the last 5 years, negative pain evaluation and pain that was thought to be from adhesions.

After signing consent patients completed a one week baseline pain and sleep evaluation. Patients completed a Short-Form McGill Pain Questionaire during screening and at randomization. Patients had an average daily diary score of at least 4 on the the Likert scale during the baseline week and 5 diary recordings with stable pain medication doses.

Participant milestones

Participant milestones
Measure	Active Drug 75-150 mg of pregabalin po BID Pregabalin : First 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg pregabalin and increase to 150 mg po BID if no improvement after 3 days	Placebo Placebo 75 or 150 mg po BID Pregabalin : 75 mg po BID Pregabalin : First 7 weeks 75 or 150 mg of placebo pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days
Placebo Controlled Double Blind STARTED	11	7
Placebo Controlled Double Blind COMPLETED	8	5
Placebo Controlled Double Blind NOT COMPLETED	3	2
Open Label STARTED	8	5
Open Label COMPLETED	7	3
Open Label NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pregabalin for Abdominal Pain From Adhesions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Drug n=11 Participants 75-150 mg of pregabalin po BID Pregabalin : First 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days	Placebo n=7 Participants Placebo 75 or 150 mg po BID Pregabalin : 75 mg po BID Pregabalin : First 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=99 Participants	5 Participants n=107 Participants	16 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants
Age, Continuous	44.27 years STANDARD_DEVIATION 11.73 • n=99 Participants	48.85 years STANDARD_DEVIATION 16.94 • n=107 Participants	46.05 years STANDARD_DEVIATION 13.69 • n=206 Participants
Sex: Female, Male Female	11 Participants n=99 Participants	7 Participants n=107 Participants	18 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	11 participants n=99 Participants	7 participants n=107 Participants	18 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline and week 2 through week 12

Population: The number of patients required per treatment group to achieve greater tha 80% power with alpha=0.05 were based on rates from published articles. The study was terminated early due to low enrollment.

Outcome measures

Outcome measures
Measure	Patients Treated With Placebo n=7 Participants Patients treated with look alike pregabalin placebo 75 or 150 mg BID for seven weeks followed by a week wash out and 150 mg BID of pregabalin	Patients Treated With Pregabalin n=11 Participants Patients treated with pregabalin 75 or 150 mg po BID
Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo baseline pain score	5.8 units on a scale Standard Deviation 0.96	6.15 units on a scale Standard Deviation 0.72
Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo week 2	5.22 units on a scale Standard Deviation 2.29	2.87 units on a scale Standard Deviation 2.28
Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo week 3	4.64 units on a scale Standard Deviation 1.66	1.88 units on a scale Standard Deviation 1.0
Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo week 4	4.84 units on a scale Standard Deviation 1.28	3.31 units on a scale Standard Deviation 2.60
Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo week 5	4.32 units on a scale Standard Deviation 1.57	2.72 units on a scale Standard Deviation 2.05
Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo week 6	3.88 units on a scale Standard Deviation 1.82	2.49 units on a scale Standard Deviation 1.7
Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo week 7	3.92 units on a scale Standard Deviation 1.76	2.53 units on a scale Standard Deviation 2.19
Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo week 8 open label with no study medication	4.13 units on a scale Standard Deviation 0.51	2.46 units on a scale Standard Deviation 2.36
Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo week 9 open label	2.21 units on a scale Standard Deviation 0.74	2.06 units on a scale Standard Deviation 2.24
Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo week 10 open label	2.27 units on a scale Standard Deviation 0.74	1.84 units on a scale Standard Deviation 2.13
Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo week 11 open label	2.23 units on a scale Standard Deviation 1.55	1.46 units on a scale Standard Deviation 2.03
Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo week 12 open label	1.13 units on a scale Standard Deviation 1.15	1.68 units on a scale Standard Deviation 1.93

SECONDARY outcome

Timeframe: Baseline and week 2 through week 12

Population: Pregabalin patients received 150mg or 300 mg for seven weeks and placebo patients received a look alike placebo for seven weeks. All patients received open label 300 mg of placebo for 4 weeks after a one week wash out phase at week 8.

Absolute Improvement in Sleep by assessing Mean Daily sleep interference scores as measured weekly starting at baseline and reported weekly through week 12 excluding the first week. This score is an 11 point scale the documents the pain interference in sleep in the preceding 24 hours. 0 is no interference and 10 is pain completely disrupted sleep in the previous 24 hours. During the study patients recorded a daily sleep interference score based on 11 point scale (0-10) with the higher number being the most sleep interference

Outcome measures

Outcome measures
Measure	Patients Treated With Placebo n=7 Participants Patients treated with look alike pregabalin placebo 75 or 150 mg BID for seven weeks followed by a week wash out and 150 mg BID of pregabalin	Patients Treated With Pregabalin n=11 Participants Patients treated with pregabalin 75 or 150 mg po BID
Improved Sleep Scores baseline	4.66 units on a scale Standard Deviation 2.79	3.94 units on a scale Standard Deviation 2.22
Improved Sleep Scores week 2	3.4 units on a scale Standard Deviation 3.41	2.20 units on a scale Standard Deviation 2.36
Improved Sleep Scores week 3	3.26 units on a scale Standard Deviation 3.11	1.60 units on a scale Standard Deviation 1.72
Improved Sleep Scores week 4	3.54 units on a scale Standard Deviation 2.81	1.68 units on a scale Standard Deviation 1.78
Improved Sleep Scores week 5	3.06 units on a scale Standard Deviation 2.90	1.68 units on a scale Standard Deviation 1.75
Improved Sleep Scores week 6	2.74 units on a scale Standard Deviation 2.60	1.55 units on a scale Standard Deviation 1.77
Improved Sleep Scores week 7	3.18 units on a scale Standard Deviation 2.27	1.6 units on a scale Standard Deviation 2.09
Improved Sleep Scores week 8 open label no study medication	3.30 units on a scale Standard Deviation 1.13	1.82 units on a scale Standard Deviation 2.15
Improved Sleep Scores week 9 open label	1.70 units on a scale Standard Deviation 0.88	1.31 units on a scale Standard Deviation 1.84
Improved Sleep Scores week 10 open label	1.25 units on a scale Standard Deviation 0.98	1.37 units on a scale Standard Deviation 1.83
Improved Sleep Scores week 11 open label	1.18 units on a scale Standard Deviation 0.95	1.39 units on a scale Standard Deviation 2.04
Improved Sleep Scores week 12 open label	0.56 units on a scale Standard Deviation 0.55	1.01 units on a scale Standard Deviation 1.43

Adverse Events

Active Drug 150 mg Double-blind and 300 mg Open-label

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Active Drug 300mg Double-blind and 300mg Open-label

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo (150 mg or 300mg): Double-Blind

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo (300 mg Active Drug): Open-label Only

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active Drug 150 mg Double-blind and 300 mg Open-label n=5 participants at risk Double-Blind: 75 mg of pregabalin po BID (Weeks1-7) Open-label:150 mg of pregabalin BID (Weeks 8-11) Pregabalin : First 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days	Active Drug 300mg Double-blind and 300mg Open-label n=6 participants at risk Double blink:150 mg of pregabalin BID (Weeks 1-7) Open-label: 150 mg of pregabalin BID (Weeks 8-11) Pregabalin : First 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days	Placebo (150 mg or 300mg): Double-Blind n=7 participants at risk Double-blind: Placebo (150 or 300 mg) for weeks 1-7 only.	Placebo (300 mg Active Drug): Open-label Only n=5 participants at risk Participants who received placebo during the Double-blind phase had the option to receive pregabalin 150 mg BID during the open-label phase for 4 weeks (Weeks 8-11 only).
Psychiatric disorders Suicide attempt	0.00% 0/5 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	16.7% 1/6 • Number of events 1 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/7 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/5 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.

Other adverse events

Other adverse events
Measure	Active Drug 150 mg Double-blind and 300 mg Open-label n=5 participants at risk Double-Blind: 75 mg of pregabalin po BID (Weeks1-7) Open-label:150 mg of pregabalin BID (Weeks 8-11) Pregabalin : First 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days	Active Drug 300mg Double-blind and 300mg Open-label n=6 participants at risk Double blink:150 mg of pregabalin BID (Weeks 1-7) Open-label: 150 mg of pregabalin BID (Weeks 8-11) Pregabalin : First 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days	Placebo (150 mg or 300mg): Double-Blind n=7 participants at risk Double-blind: Placebo (150 or 300 mg) for weeks 1-7 only.	Placebo (300 mg Active Drug): Open-label Only n=5 participants at risk Participants who received placebo during the Double-blind phase had the option to receive pregabalin 150 mg BID during the open-label phase for 4 weeks (Weeks 8-11 only).
Nervous system disorders headache and hyperactivity	20.0% 1/5 • Number of events 1 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/6 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/7 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/5 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.
Blood and lymphatic system disorders night sweats	0.00% 0/5 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	16.7% 1/6 • Number of events 1 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/7 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/5 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.
Ear and labyrinth disorders dizziness	20.0% 1/5 • Number of events 1 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/6 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/7 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	20.0% 1/5 • Number of events 1 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.
General disorders drowsiness	0.00% 0/5 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	16.7% 1/6 • Number of events 1 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/7 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/5 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.
Nervous system disorders dizziness and blurred vision	20.0% 1/5 • Number of events 1 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/6 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/7 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/5 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.
Nervous system disorders hand numbness	0.00% 0/5 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	16.7% 1/6 • Number of events 1 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/7 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/5 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.
Metabolism and nutrition disorders gastroenteritis and dizziness	0.00% 0/5 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/6 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	14.3% 1/7 • Number of events 1 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/5 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.
Blood and lymphatic system disorders pedal edema	0.00% 0/5 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/6 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	14.3% 1/7 • Number of events 1 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.	0.00% 0/5 • Adverse events were collected over 5 months. Enrolled patients were scheduled for a minimum of three visits after the first week of treatment at weeks 4,8 and 12 for physical examination, symptom assessment and laboratory studies. Patients were contacted by phone 2 months after completing the study to review general health and adverse events. Deaths and/or adverse events were not monitored/assessed separately between the double-blind and open-label phases in the Active Drug arms.

Additional Information

Dr. Ann Silverman

retired

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place