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A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01085097
Recruitment Status : Completed
First Posted : March 11, 2010
Results First Posted : March 9, 2022
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Lupus Nephritis
Interventions Drug: Laquinimod
Drug: Mycophenolate Mofetil
Drug: Prednisolone/Prednisone
Drug: Placebo
Drug: Methylprednisolone
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Laquinimod 0.5 mg Laquinimod 1 mg
Hide Arm/Group Description Participants received 2 capsules of placebo matched to laquinimod orally once daily (QD) for 24 weeks, mycophenolate mofetil (MMF) 500 milligrams (mg) tablet orally twice daily (BID) for the first week then 1 gram (g) BID from Week 2 to Week 28, and methylprednisolone (MP) 500 mg/day intravenously(IV) from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28. Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28. Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
Period Title: Overall Study
Started 15 16 15
Received at Least 1 Dose of Study Drug 15 16 15
Completed 13 16 13
Not Completed 2 0 2
Reason Not Completed
Adverse Event             0             0             2
Treatment failure             2             0             0
Arm/Group Title Placebo Laquinimod 0.5 mg Laquinimod 1 mg Total
Hide Arm/Group Description Participants received 2 capsules of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28. Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28. Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28. Total of all reporting groups
Overall Number of Baseline Participants 15 16 15 46
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) analysis set included all participants randomly assigned to treatment. In this population, treatment was assigned based on the treatment to which participants were randomly assigned, regardless of which treatment they actually received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 16 participants 15 participants 46 participants
33.4  (10.9) 35.3  (11.5) 32.7  (9.7) 33.8  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 15 participants 46 participants
Female
11
  73.3%
10
  62.5%
13
  86.7%
34
  73.9%
Male
4
  26.7%
6
  37.5%
2
  13.3%
12
  26.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 15 participants 46 participants
Asian
2
  13.3%
0
   0.0%
1
   6.7%
3
   6.5%
Black or African American
3
  20.0%
4
  25.0%
1
   6.7%
8
  17.4%
White
7
  46.7%
11
  68.8%
9
  60.0%
27
  58.7%
Hispanic
2
  13.3%
1
   6.3%
4
  26.7%
7
  15.2%
Other
1
   6.7%
0
   0.0%
0
   0.0%
1
   2.2%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Time Frame Baseline up to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
Arm/Group Title Placebo Laquinimod 0.5 mg Laquinimod 1 mg
Hide Arm/Group Description:
Participants received 2 capsules of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
Overall Number of Participants Analyzed 15 16 15
Measure Type: Number
Unit of Measure: participants
14 15 15
2.Primary Outcome
Title Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
Hide Description Estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease (MDRD) formula.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) analysis set included all randomized participants, excluding observations after treatment failure.
Arm/Group Title Placebo Laquinimod 0.5 mg Laquinimod 1 mg
Hide Arm/Group Description:
Participants received 2 capsules of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
Overall Number of Participants Analyzed 15 16 15
Mean (Standard Deviation)
Unit of Measure: percent change
12.1  (20.17) 18.0  (30.65) 24.3  (28.84)
Time Frame Baseline up to Week 28
Adverse Event Reporting Description Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.
 
Arm/Group Title Placebo Laquinimod 0.5 mg Laquinimod 1 mg
Hide Arm/Group Description Participants received 2 capsules of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28. Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28. Participants received 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which was tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
All-Cause Mortality
Placebo Laquinimod 0.5 mg Laquinimod 1 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/16 (0.00%)      1/15 (6.67%)    
Hide Serious Adverse Events
Placebo Laquinimod 0.5 mg Laquinimod 1 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/15 (26.67%)      4/16 (25.00%)      4/15 (26.67%)    
Blood and lymphatic system disorders       
Anaemia † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 1/15 (6.67%)  1
Disseminated Intravascular Coagulation † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Leukopenia † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Thrombocytopenia † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Cardiac disorders       
Atrial Fibrillation † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Cardio-Respiratory Arrest † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Gastrointestinal disorders       
Gastroduodenitis † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
General disorders       
Generalised Oedema † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Infections and infestations       
Cellulitis † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Herpes Zoster † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Pneumonia † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 1/15 (6.67%)  1
Sepsis † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Tracheobronchitis † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Metabolism and nutrition disorders       
Fluid Overload † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Systemic Lupus Erythematosus † 1  1/15 (6.67%)  1 1/16 (6.25%)  1 0/15 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Abortion Spontaneous † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Renal and urinary disorders       
Renal Failure Acute † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders       
Pleuritic Pain † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Pulmonary Embolism † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Skin and subcutaneous tissue disorders       
Skin Necrosis † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Vascular disorders       
Deep Vein Thrombosis † 1  1/15 (6.67%)  1 1/16 (6.25%)  1 0/15 (0.00%)  0
Thrombophlebitis Superficial † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
1
Term from vocabulary, MedDRA 15.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Laquinimod 0.5 mg Laquinimod 1 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/15 (93.33%)      13/16 (81.25%)      15/15 (100.00%)    
Blood and lymphatic system disorders       
Anaemia † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 2/15 (13.33%)  2
Lymphadenopathy † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Lymphopenia † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Thrombocytopenia † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Cardiac disorders       
Sinus Tachycardia † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 2/15 (13.33%)  2
Ear and labyrinth disorders       
Ear Pain † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Middle Ear Effusion † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Endocrine disorders       
Cushing's Syndrome † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 1/15 (6.67%)  1
Eye disorders       
Conjunctivitis † 1  0/15 (0.00%)  0 2/16 (12.50%)  3 1/15 (6.67%)  1
Dry Eye † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Visual Impairment † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Gastrointestinal disorders       
Abdominal Pain † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Abdominal Pain Lower † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Abdominal Pain Upper † 1  0/15 (0.00%)  0 2/16 (12.50%)  3 0/15 (0.00%)  0
Constipation † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 2/15 (13.33%)  2
Diarrhoea † 1  1/15 (6.67%)  1 2/16 (12.50%)  2 3/15 (20.00%)  3
Dyspepsia † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 1/15 (6.67%)  1
Dysphagia † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Flatulence † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Gastritis † 1  1/15 (6.67%)  1 1/16 (6.25%)  1 0/15 (0.00%)  0
Gastrooesophageal Reflux Disease † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 1/15 (6.67%)  1
Gingival Recession † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Haemorrhoids † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Inguinal Hernia † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Irritable Bowel Syndrome † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Nausea † 1  3/15 (20.00%)  3 2/16 (12.50%)  2 2/15 (13.33%)  2
Vomiting † 1  2/15 (13.33%)  2 2/16 (12.50%)  2 0/15 (0.00%)  0
General disorders       
Asthenia † 1  2/15 (13.33%)  3 0/16 (0.00%)  0 0/15 (0.00%)  0
Chills † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Fatigue † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Generalised Oedema † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Non-Cardiac Chest Pain † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Oedema † 1  0/15 (0.00%)  0 1/16 (6.25%)  2 0/15 (0.00%)  0
Oedema Peripheral † 1  4/15 (26.67%)  6 2/16 (12.50%)  2 2/15 (13.33%)  2
Pyrexia † 1  2/15 (13.33%)  2 0/16 (0.00%)  0 0/15 (0.00%)  0
Infections and infestations       
Bronchitis † 1  1/15 (6.67%)  1 2/16 (12.50%)  2 1/15 (6.67%)  1
Cystitis † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Escherichia Urinary Tract Infection † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 2/15 (13.33%)  5
Folliculitis † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Herpes Zoster † 1  2/15 (13.33%)  3 0/16 (0.00%)  0 3/15 (20.00%)  3
Nasopharyngitis † 1  1/15 (6.67%)  1 1/16 (6.25%)  1 1/15 (6.67%)  1
Oral Candidiasis † 1  1/15 (6.67%)  2 0/16 (0.00%)  0 0/15 (0.00%)  0
Oral Fungal Infection † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Sinusitis † 1  2/15 (13.33%)  2 2/16 (12.50%)  3 0/15 (0.00%)  0
Subcutaneous Abscess † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Tinea Pedis † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Upper Respiratory Tract Infection † 1  3/15 (20.00%)  3 1/16 (6.25%)  1 0/15 (0.00%)  0
Urinary Tract Infection † 1  0/15 (0.00%)  0 4/16 (25.00%)  5 2/15 (13.33%)  2
Urinary Tract Infection Bacterial † 1  1/15 (6.67%)  2 0/16 (0.00%)  0 1/15 (6.67%)  1
Varicella † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Injury, poisoning and procedural complications       
Concussion † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Contusion † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Excoriation † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Fall † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Muscle Strain † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Procedural Pain † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Investigations       
Bacterial Test Positive † 1  1/15 (6.67%)  1 1/16 (6.25%)  1 0/15 (0.00%)  0
Blood Albumin Increased † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Blood Glucose Increased † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Blood Urea Increased † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
C-Reactive Protein Increased † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Haemoglobin Decreased † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Weight Decreased † 1  2/15 (13.33%)  2 3/16 (18.75%)  3 0/15 (0.00%)  0
Weight Increased † 1  3/15 (20.00%)  3 3/16 (18.75%)  3 0/15 (0.00%)  0
Metabolism and nutrition disorders       
Hyperlipidaemia † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Macroamylasaemia † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Vitamin B12 Deficiency † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  2/15 (13.33%)  3 2/16 (12.50%)  3 1/15 (6.67%)  1
Back Pain † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Bone Pain † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Joint Lock † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Joint Swelling † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Muscle Spasms † 1  3/15 (20.00%)  4 3/16 (18.75%)  5 1/15 (6.67%)  1
Musculoskeletal Chest Pain † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 1/15 (6.67%)  1
Musculoskeletal Pain † 1  1/15 (6.67%)  2 0/16 (0.00%)  0 0/15 (0.00%)  0
Myalgia † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Neck Pain † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 1/15 (6.67%)  1
Osteonecrosis † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Pain In Extremity † 1  1/15 (6.67%)  1 2/16 (12.50%)  3 0/15 (0.00%)  0
Pain In Jaw † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Synovial Cyst † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Systemic Lupus Erythematosus † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Melanocytic Naevus † 1  1/15 (6.67%)  2 0/16 (0.00%)  0 0/15 (0.00%)  0
Skin Papilloma † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Nervous system disorders       
Ageusia † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Burning Sensation † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Dizziness † 1  1/15 (6.67%)  1 1/16 (6.25%)  2 0/15 (0.00%)  0
Headache † 1  1/15 (6.67%)  1 4/16 (25.00%)  6 0/15 (0.00%)  0
Hypoaesthesia † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 1/15 (6.67%)  1
Migraine † 1  0/15 (0.00%)  0 1/16 (6.25%)  4 0/15 (0.00%)  0
Paraesthesia † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Sinus Headache † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Tremor † 1  1/15 (6.67%)  1 1/16 (6.25%)  1 0/15 (0.00%)  0
Psychiatric disorders       
Affect Lability † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Anxiety † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Depressed Mood † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Insomnia † 1  0/15 (0.00%)  0 3/16 (18.75%)  3 2/15 (13.33%)  2
Renal and urinary disorders       
Dysuria † 1  1/15 (6.67%)  1 1/16 (6.25%)  3 0/15 (0.00%)  0
Reproductive system and breast disorders       
Haematospermia † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Menorrhagia † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Polymenorrhoea † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Uterine Haemorrhage † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Vaginal Discharge † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Vaginal Haemorrhage † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders       
Cough † 1  1/15 (6.67%)  1 1/16 (6.25%)  1 2/15 (13.33%)  3
Dyspnoea † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Dyspnoea Exertional † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Epistaxis † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Increased Upper Airway Secretion † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Oropharyngeal Pain † 1  2/15 (13.33%)  2 0/16 (0.00%)  0 0/15 (0.00%)  0
Productive Cough † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Rhinorrhoea † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 1/15 (6.67%)  1
Rhonchi † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Sinus Congestion † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Skin and subcutaneous tissue disorders       
Alopecia † 1  2/15 (13.33%)  2 0/16 (0.00%)  0 2/15 (13.33%)  2
Dry Skin † 1  2/15 (13.33%)  2 0/16 (0.00%)  0 0/15 (0.00%)  0
Intertrigo † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Papule † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Pruritus † 1  1/15 (6.67%)  2 1/16 (6.25%)  1 0/15 (0.00%)  0
Rash † 1  2/15 (13.33%)  2 0/16 (0.00%)  0 0/15 (0.00%)  0
Rash Erythematous † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Rash Papular † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Skin Exfoliation † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Skin Ulcer † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Surgical and medical procedures       
Vasectomy † 1  0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Vascular disorders       
Flushing † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Hot Flush † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Hypertension † 1  1/15 (6.67%)  1 0/16 (0.00%)  0 1/15 (6.67%)  1
Hypotension † 1  0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
1
Term from vocabulary, MedDRA 15.0
†
Indicates events were collected by systematic assessment
[Not Specified]
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.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products R&D, Inc.
Phone: 1-888-483-8279
EMail: USMedInfo@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT01085097    
Other Study ID Numbers: LN-LAQ-201
2010-018329-20 ( EudraCT Number )
First Submitted: March 4, 2010
First Posted: March 11, 2010
Results First Submitted: February 14, 2022
Results First Posted: March 9, 2022
Last Update Posted: March 9, 2022