Trial Outcomes & Findings for Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia. (NCT NCT00423605)
NCT ID: NCT00423605
Last Updated: 2012-03-30
Results Overview
Number of subjects reporting adverse events.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
560 participants
Primary outcome timeframe
Treatment Period (38 weeks)
Results posted on
2012-03-30
Participant Flow
Participant milestones
| Measure |
Xyrem 4.5 g to 9.0 g
Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
|
|---|---|
|
Overall Study
STARTED
|
560
|
|
Overall Study
COMPLETED
|
319
|
|
Overall Study
NOT COMPLETED
|
241
|
Reasons for withdrawal
| Measure |
Xyrem 4.5 g to 9.0 g
Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
|
|---|---|
|
Overall Study
Adverse Event
|
129
|
|
Overall Study
Withdrawal by Subject
|
36
|
|
Overall Study
Lost to Follow-up
|
15
|
|
Overall Study
Lack of Efficacy
|
38
|
|
Overall Study
Sponsor Decision
|
3
|
|
Overall Study
Physician Decision
|
8
|
|
Overall Study
Protocol Violation
|
7
|
|
Overall Study
Not one of the pre-specified options
|
5
|
Baseline Characteristics
Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
Baseline characteristics by cohort
| Measure |
Xyrem 4.5 g to 9.0 g
n=560 Participants
Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
|
|---|---|
|
Age Continuous
|
46.9 years
STANDARD_DEVIATION 10.84 • n=5 Participants
|
|
Age, Customized
18 - 39 years
|
144 participants
n=5 Participants
|
|
Age, Customized
40 - 49 years
|
181 participants
n=5 Participants
|
|
Age, Customized
50 - 64 years
|
212 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
23 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
510 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
512 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
13 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
465 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
35 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
34 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment Period (38 weeks)Number of subjects reporting adverse events.
Outcome measures
| Measure |
Xyrem 4.5 g to 9.0 g
n=560 Participants
Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
|
|---|---|
|
Number of Subjects Reporting Adverse Events
|
498 Participants
|
Adverse Events
Xyrem 4.5 g to 9.0 g
Serious events: 19 serious events
Other events: 498 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Xyrem 4.5 g to 9.0 g
n=560 participants at risk
Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
Gastrointestinal disorders
Gastrointestinal Hypomotility
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
General disorders
Chest Pain
|
0.36%
2/560 • Number of events 2 • 38 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.36%
2/560 • Number of events 2 • 38 weeks
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
Infections and infestations
Diverticulitis
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
Injury, poisoning and procedural complications
Accident
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer in Situ
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
Nervous system disorders
Encephalopathy
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
Psychiatric disorders
Mental Disorder
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
Reproductive system and breast disorders
Endometriosis
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
|
Vascular disorders
Arteriosclerosis
|
0.18%
1/560 • Number of events 1 • 38 weeks
|
Other adverse events
| Measure |
Xyrem 4.5 g to 9.0 g
n=560 participants at risk
Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
2.1%
12/560 • 38 weeks
|
|
Eye disorders
Vision Blurred
|
3.2%
18/560 • 38 weeks
|
|
Gastrointestinal disorders
Nausea
|
20.0%
112/560 • 38 weeks
|
|
Gastrointestinal disorders
Vomiting
|
9.3%
52/560 • 38 weeks
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.7%
15/560 • 38 weeks
|
|
General disorders
Fatigue
|
4.3%
24/560 • 38 weeks
|
|
General disorders
Pyrexia
|
2.5%
14/560 • 38 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
8.8%
49/560 • 38 weeks
|
|
General disorders
Oedema Peripheral
|
2.3%
13/560 • 38 weeks
|
|
General disorders
Pain
|
2.1%
12/560 • 38 weeks
|
|
Infections and infestations
Nasopharyngitis
|
10.2%
57/560 • 38 weeks
|
|
Infections and infestations
Sinusitis
|
8.9%
50/560 • 38 weeks
|
|
Infections and infestations
Influenza
|
6.6%
37/560 • 38 weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.1%
34/560 • 38 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
3.9%
22/560 • 38 weeks
|
|
Infections and infestations
Bronchitis
|
3.2%
18/560 • 38 weeks
|
|
Infections and infestations
Gastroenteritis Viral
|
2.9%
16/560 • 38 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
3.6%
20/560 • 38 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
2.1%
12/560 • 38 weeks
|
|
Investigations
Weight Decreased
|
3.8%
21/560 • 38 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
16/560 • 38 weeks
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
2.3%
13/560 • 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.2%
29/560 • 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
21/560 • 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
3.6%
20/560 • 38 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.2%
18/560 • 38 weeks
|
|
Nervous system disorders
Headache
|
18.9%
106/560 • 38 weeks
|
|
Nervous system disorders
Dizziness
|
12.9%
72/560 • 38 weeks
|
|
Nervous system disorders
Somnolence
|
6.1%
34/560 • 38 weeks
|
|
Nervous system disorders
Tremor
|
3.6%
20/560 • 38 weeks
|
|
Nervous system disorders
Paraesthesia
|
3.2%
18/560 • 38 weeks
|
|
Nervous system disorders
Migraine
|
2.1%
12/560 • 38 weeks
|
|
Psychiatric disorders
Anxiety
|
7.9%
44/560 • 38 weeks
|
|
Psychiatric disorders
Insomnia
|
6.8%
38/560 • 38 weeks
|
|
Psychiatric disorders
Depression
|
4.3%
24/560 • 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.2%
18/560 • 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
3.2%
18/560 • 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.0%
17/560 • 38 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
16/560 • 38 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.7%
15/560 • 38 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.3%
13/560 • 38 weeks
|
|
Vascular disorders
Hypertension
|
3.0%
17/560 • 38 weeks
|
Additional Information
Grace Wang, MD, Director Clinical Development & Medical Monitor
Jazz Pharmaceuticals, Inc.
Phone: 650-496-3777
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER