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Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients

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ClinicalTrials.gov Identifier: NCT00086281
Recruitment Status : Completed
First Posted : July 1, 2004
Results First Posted : February 24, 2012
Last Update Posted : February 24, 2012
Sponsor:
Information provided by:
Jazz Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Obstructive Sleep Apnea Syndrome
Interventions Drug: Xyrem (X)
Drug: Zolpidem (Z)
Drug: Modafinil (M)
Drug: Placebo (P)
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title P Then X Then Z With P Then X With M X Then X With M Then P Then Z With P X With M Then Z With P Then X Then P Z With P Then P Then X With M Then X P Then X Then P Then X With M Then Z With P X Then Z With P Then X With M Then P X Then Z With P Then P Then X With M X Then X Then P Then Z With P X With M Then X Then P Then Z With P P Then X Then Z With P Z With P Then P Then X With M P Then X Placebo Xyrem X With M
Hide Arm/Group Description Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment). Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later. Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later. Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later. Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later. Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later. Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment). Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later. Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later. Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later. Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment). Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later. Placebo was given at bedtime and again 2.5 to 4 hours later Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later. Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
Period Title: Phase 1
Started 11 12 8 11 1 3 1 1 2 1 3 1 1 1 3
Completed 11 12 8 11 1 3 1 1 2 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 1 3 1 1 1 3
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             0             0             1             2             1             1             1             2
Protocol Violation             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0
Serious Adverse Event             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1
Period Title: Phase 2
Started 0 0 0 0 0 0 0 0 0 0 0 0 23 27 0
Completed 0 0 0 0 0 0 0 0 0 0 0 0 22 26 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             0             0             0             0             0             1             1             0
Arm/Group Title P Then X Then Z With P Then X With M X Then X With M Then P Then Z With P X With M Then Z With P Then X Then P Z With P Then P Then X With M Then X P Then X Then P Then X With M Then Z With P X Then Z With P Then X With M Then P X Then Z With P Then P Then X With M X Then X Then P Then Z With P X With M Then X Then P Then Z With P P Then X Then Z With P Z With P Then P Then X With M P Then X Placebo Xyrem X With M Total
Hide Arm/Group Description Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment). Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later. Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later. Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later. Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later. Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later. Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment). Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later. Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later. Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later. Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment). Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later. Placebo was given at bedtime and again 2.5 to 4 hours later Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later. Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment). Total of all reporting groups
Overall Number of Baseline Participants 11 12 8 11 1 3 1 1 2 1 3 1 1 1 3 60
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 12 participants 8 participants 11 participants 1 participants 3 participants 1 participants 1 participants 2 participants 1 participants 3 participants 1 participants 1 participants 1 participants 3 participants 60 participants
50.9  (9.63) 46.3  (11.39) 49.4  (4.44) 50.5  (8.45) 49.0  (0) 47.3  (6.11) 61.0  (0) 42.0  (0) 64.0  (18.38) 43.0  (0) 59.3  (7.77) 63.0  (0) 61.0  (0) 36.0  (0) 48.0  (7.00) 50.2  (9.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 8 participants 11 participants 1 participants 3 participants 1 participants 1 participants 2 participants 1 participants 3 participants 1 participants 1 participants 1 participants 3 participants 60 participants
Female
0
   0.0%
4
  33.3%
3
  37.5%
2
  18.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
 100.0%
2
  66.7%
1
 100.0%
0
   0.0%
0
   0.0%
1
  33.3%
14
  23.3%
Male
11
 100.0%
8
  66.7%
5
  62.5%
9
  81.8%
1
 100.0%
3
 100.0%
1
 100.0%
1
 100.0%
2
 100.0%
0
   0.0%
1
  33.3%
0
   0.0%
1
 100.0%
1
 100.0%
2
  66.7%
46
  76.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 8 participants 11 participants 1 participants 3 participants 1 participants 1 participants 2 participants 1 participants 3 participants 1 participants 1 participants 1 participants 3 participants 60 participants
Caucasian 10 10 8 10 1 3 1 1 1 1 3 1 1 1 2 54
Black 0 1 0 1 0 0 0 0 1 0 0 0 0 0 1 4
Asian 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
Hispanic 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1
1.Primary Outcome
Title The Primary Efficacy Variable Was the Mean Apnea-Hypopnea Index (AHI).
Hide Description The AHI was defined as the incidence(events per hour) of apnea and hypopnea events associated with sleep, determined from the overnight polysomnogram (PSG). An apnea event is characterized by a cessation in airflow lasting >= 10 seconds, accompanied by oxygen desaturation of >3% or arousal. An Hyponea event is characterized by a transient reduction in breathing lasting >= 10 seconds, with clear decrease (>50%) from baseline in the amplitude of breathing or a decrease <50% in the amplitude of breathing accompanied by oxygen desaturation of >3% or arousal.
Time Frame One night of PSG during one night of treatment each per arm.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Xyrem Xyrem + Modafinil Zolpidem + Placebo
Hide Arm/Group Description:
Placebo
Xyrem
Xyrem + Modafinil
Zolpidem + Placebo
Overall Number of Participants Analyzed 50 50 49 50
Mean (Standard Deviation)
Unit of Measure: Apnea + Hypopnea episodes per hour
22.33  (10.836) 18.18  (11.280) 21.10  (13.463) 22.71  (10.618)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Xyrem, Xyrem + Modafinil, Zolpidem + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method ANOVA on ranks
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Xyrem
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0244
Comments Bonferroni adjusted P-Value
Method ANOVA on ranks
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Xyrem, Zolpidem + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0119
Comments Bonferroni adjusted P-Value
Method ANOVA on ranks
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Xyrem + Modafinil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5055
Comments Bonferroni adjusted P-Value
Method ANOVA on ranks
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Xyrem + Modafinil, Zolpidem + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3132
Comments Bonferroni adjusted P-Value
Method ANOVA on ranks
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Xyrem X + M Z + P
Hide Arm/Group Description Placebo Xyrem Xyrem + Modafinil Zolpidem + Placebo
All-Cause Mortality
Placebo Xyrem X + M Z + P
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Xyrem X + M Z + P
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/53 (0.00%)   1/55 (1.82%)   0/54 (0.00%) 
Gastrointestinal disorders         
Nausea * 1  0/56 (0.00%)  0/53 (0.00%)  1/55 (1.82%)  0/54 (0.00%) 
Vomiting * 1  0/56 (0.00%)  0/53 (0.00%)  1/55 (1.82%)  0/54 (0.00%) 
Investigations         
Blood Pressure Increased * 1  0/56 (0.00%)  0/53 (0.00%)  1/55 (1.82%)  0/54 (0.00%) 
Nervous system disorders         
Hypoaesthesia * 1  0/56 (0.00%)  0/53 (0.00%)  1/55 (1.82%)  0/54 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (8.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Xyrem X + M Z + P
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/56 (33.93%)   18/53 (33.96%)   17/55 (30.91%)   11/54 (20.37%) 
Cardiac disorders         
Tachycardia * 1  0/56 (0.00%)  0/53 (0.00%)  0/55 (0.00%)  1/54 (1.85%) 
Ventricular Extrasystoles * 1  1/56 (1.79%)  0/53 (0.00%)  0/55 (0.00%)  0/54 (0.00%) 
Ear and labyrinth disorders         
Vertigo * 1  0/56 (0.00%)  1/53 (1.89%)  0/55 (0.00%)  0/54 (0.00%) 
Eye disorders         
Asthenopia * 1  1/56 (1.79%)  0/53 (0.00%)  0/55 (0.00%)  0/54 (0.00%) 
Eye Pain * 1  1/56 (1.79%)  0/53 (0.00%)  0/55 (0.00%)  0/54 (0.00%) 
Vision Blurred * 1  0/56 (0.00%)  1/53 (1.89%)  0/55 (0.00%)  0/54 (0.00%) 
Gastrointestinal disorders         
Abdominal Distension * 1  1/56 (1.79%)  0/53 (0.00%)  0/55 (0.00%)  0/54 (0.00%) 
Abdominal Pain Upper * 1  1/56 (1.79%)  0/53 (0.00%)  0/55 (0.00%)  0/54 (0.00%) 
Constipation * 1  1/56 (1.79%)  0/53 (0.00%)  0/55 (0.00%)  0/54 (0.00%) 
Diarrhoea * 1  0/56 (0.00%)  2/53 (3.77%)  0/55 (0.00%)  1/54 (1.85%) 
Dry Mouth * 1  0/56 (0.00%)  0/53 (0.00%)  1/55 (1.82%)  0/54 (0.00%) 
Dyspepsia * 1  0/56 (0.00%)  1/53 (1.89%)  0/55 (0.00%)  0/54 (0.00%) 
Nausea * 1  3/56 (5.36%)  1/53 (1.89%)  7/55 (12.73%)  3/54 (5.56%) 
Stomach Discomfort * 1  0/56 (0.00%)  0/53 (0.00%)  1/55 (1.82%)  0/54 (0.00%) 
Vomiting * 1  0/56 (0.00%)  0/53 (0.00%)  3/55 (5.45%)  0/54 (0.00%) 
General disorders         
Fatigue * 1  2/56 (3.57%)  0/53 (0.00%)  2/55 (3.64%)  0/54 (0.00%) 
Feeling Abnormal * 1  0/56 (0.00%)  0/53 (0.00%)  1/55 (1.82%)  1/54 (1.85%) 
Infections and infestations         
Bronchitis * 1  1/56 (1.79%)  0/53 (0.00%)  0/55 (0.00%)  0/54 (0.00%) 
Gastroenteritis Viral * 1  0/56 (0.00%)  0/53 (0.00%)  1/55 (1.82%)  0/54 (0.00%) 
Pharyngitis * 1  0/56 (0.00%)  0/53 (0.00%)  1/55 (1.82%)  0/54 (0.00%) 
Upper Respiratory Tract Infection * 1  0/56 (0.00%)  0/53 (0.00%)  0/55 (0.00%)  1/54 (1.85%) 
Injury, poisoning and procedural complications         
Limb Injury * 1  0/56 (0.00%)  1/53 (1.89%)  0/55 (0.00%)  0/54 (0.00%) 
Tooth Injury * 1  1/56 (1.79%)  0/53 (0.00%)  0/55 (0.00%)  0/54 (0.00%) 
Investigations         
Blood Pressure Increased * 1  0/56 (0.00%)  0/53 (0.00%)  1/55 (1.82%)  0/54 (0.00%) 
Oxygen Saturation Decreased * 1  0/56 (0.00%)  1/53 (1.89%)  0/55 (0.00%)  0/54 (0.00%) 
Metabolism and nutrition disorders         
Anorexia * 1  0/56 (0.00%)  1/53 (1.89%)  0/55 (0.00%)  0/54 (0.00%) 
Dehydration * 1  0/56 (0.00%)  0/53 (0.00%)  1/55 (1.82%)  0/54 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back Pain * 1  1/56 (1.79%)  0/53 (0.00%)  0/55 (0.00%)  0/54 (0.00%) 
Muscular Weakness * 1  0/56 (0.00%)  0/53 (0.00%)  0/55 (0.00%)  1/54 (1.85%) 
Musculoskeletal Stiffness * 1  1/56 (1.79%)  0/53 (0.00%)  0/55 (0.00%)  0/54 (0.00%) 
Myalgia * 1  0/56 (0.00%)  0/53 (0.00%)  1/55 (1.82%)  1/54 (1.85%) 
Rotator Cuff Syndrome * 1  0/56 (0.00%)  1/53 (1.89%)  0/55 (0.00%)  0/54 (0.00%) 
Nervous system disorders         
Disturbance in Attention * 1  0/56 (0.00%)  1/53 (1.89%)  1/55 (1.82%)  0/54 (0.00%) 
Dizziness * 1  0/56 (0.00%)  4/53 (7.55%)  3/55 (5.45%)  0/54 (0.00%) 
Headache * 1  6/56 (10.71%)  5/53 (9.43%)  9/55 (16.36%)  3/54 (5.56%) 
Hypoaesthesia * 1  0/56 (0.00%)  0/53 (0.00%)  2/55 (3.64%)  0/54 (0.00%) 
Mental Impairment * 1  0/56 (0.00%)  0/53 (0.00%)  1/55 (1.82%)  0/54 (0.00%) 
Somnolence * 1  1/56 (1.79%)  1/53 (1.89%)  0/55 (0.00%)  1/54 (1.85%) 
Syncope Vasovagal * 1  1/56 (1.79%)  0/53 (0.00%)  0/55 (0.00%)  0/54 (0.00%) 
Psychiatric disorders         
Anxiety * 1  0/56 (0.00%)  0/53 (0.00%)  2/55 (3.64%)  0/54 (0.00%) 
Disorientation * 1  1/56 (1.79%)  0/53 (0.00%)  0/55 (0.00%)  0/54 (0.00%) 
Nervousness * 1  0/56 (0.00%)  1/53 (1.89%)  0/55 (0.00%)  2/54 (3.70%) 
Panic Attack * 1  0/56 (0.00%)  0/53 (0.00%)  1/55 (1.82%)  0/54 (0.00%) 
Renal and urinary disorders         
Nephrolithiasis * 1  1/56 (1.79%)  0/53 (0.00%)  0/55 (0.00%)  0/54 (0.00%) 
Urinary Incontinence * 1  0/56 (0.00%)  2/53 (3.77%)  1/55 (1.82%)  0/54 (0.00%) 
Urine Abnormality * 1  1/56 (1.79%)  0/53 (0.00%)  0/55 (0.00%)  0/54 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dry Throat * 1  1/56 (1.79%)  1/53 (1.89%)  0/55 (0.00%)  0/54 (0.00%) 
Epistaxis * 1  1/56 (1.79%)  0/53 (0.00%)  0/55 (0.00%)  0/54 (0.00%) 
Pharyngolaryngeal Pain * 1  1/56 (1.79%)  1/53 (1.89%)  2/55 (3.64%)  2/54 (3.70%) 
Skin and subcutaneous tissue disorders         
Cold Sweat * 1  0/56 (0.00%)  0/53 (0.00%)  1/55 (1.82%)  0/54 (0.00%) 
Dry Skin * 1  1/56 (1.79%)  0/53 (0.00%)  0/55 (0.00%)  0/54 (0.00%) 
Pruritus Generalised * 1  0/56 (0.00%)  1/53 (1.89%)  0/55 (0.00%)  0/54 (0.00%) 
Vascular disorders         
Hot Flush * 1  0/56 (0.00%)  0/53 (0.00%)  1/55 (1.82%)  0/54 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (8.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Grace Wang, MD Director Clinical Development & Medical Monitor
Organization: Jazz Pharmaceuticals, Inc.
Phone: 650-496-3777
Layout table for additonal information
Responsible Party: Senior Director Clinical Development, Jazz Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00086281     History of Changes
Other Study ID Numbers: OMC-SXB-23
First Submitted: June 29, 2004
First Posted: July 1, 2004
Results First Submitted: November 11, 2011
Results First Posted: February 24, 2012
Last Update Posted: February 24, 2012