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Trial record 16 of 231 for:    CALCITONIN SALMON

Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis

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: NCT00486434
Recruitment Status : Completed
First Posted : June 14, 2007
Results First Posted : June 28, 2012
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Nordic Bioscience A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Osteoarthritis
Interventions Drug: SMC021 Oral Calcitonin
Drug: SMC021 Placebo
Enrollment 1176
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Arm Placebo Arm
Hide Arm/Group Description 0.8mg SMC021 Oral Calcitonin tablet twice daily 1 SMC021 Placebo tablet twice daily
Period Title: Overall Study
Started 588 588
Completed 394 454
Not Completed 194 134
Reason Not Completed
Withdrawal by Subject             34             39
Adverse Event             118             44
Protocol Violation             22             21
Lack of Efficacy             12             19
Lost to Follow-up             2             3
Death             1             2
Personal reasons             5             6
Arm/Group Title Active Arm Placebo Arm Total
Hide Arm/Group Description 0.8mg SMC021 Oral Calcitonin tablet twice daily 1 SMC021 Placebo tablet twice daily Total of all reporting groups
Overall Number of Baseline Participants 588 588 1176
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 588 participants 588 participants 1176 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
293
  49.8%
321
  54.6%
614
  52.2%
>=65 years
295
  50.2%
267
  45.4%
562
  47.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 588 participants 588 participants 1176 participants
64.1  (6.84) 63.9  (6.41) 64.0  (6.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 588 participants 588 participants 1176 participants
Female
418
  71.1%
386
  65.6%
804
  68.4%
Male
170
  28.9%
202
  34.4%
372
  31.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 588 participants 588 participants 1176 participants
Hong Kong 51 51 102
Czech Republic 47 48 95
Estonia 47 47 94
Poland 33 34 67
Romania 40 39 79
Denmark 370 369 739
1.Primary Outcome
Title Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months.
Hide Description The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24.
Time Frame Change from baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.
Arm/Group Title Active Arm Placebo Arm
Hide Arm/Group Description:
0.8mg SMC021 Oral Calcitonin tablet twice daily
1 SMC021 Placebo tablet twice daily
Overall Number of Participants Analyzed 585 584
Mean (Standard Deviation)
Unit of Measure: mm
-0.188  (0.5626) -0.198  (0.5069)
2.Primary Outcome
Title Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee
Hide Description WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).
Time Frame Change from baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.
Arm/Group Title Active Arm Placebo Arm
Hide Arm/Group Description:
0.8mg SMC021 Oral Calcitonin tablet twice daily
1 SMC021 Placebo tablet twice daily
Overall Number of Participants Analyzed 585 584
Median (Inter-Quartile Range)
Unit of Measure: Units on a scale
-124.0
(-391 to 218)
-109.0
(-410 to 349)
3.Primary Outcome
Title Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee.
Hide Description WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the degree of difficulty for performing each daily function listed in the questionnaire. 0 is no difficulty (best), 100 is extreme difficulty (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 1700. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less difficulty).
Time Frame Change from baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.
Arm/Group Title Active Arm Placebo Arm
Hide Arm/Group Description:
0.8mg SMC021 Oral Calcitonin tablet twice daily
1 SMC021 Placebo tablet twice daily
Overall Number of Participants Analyzed 585 584
Median (Inter-Quartile Range)
Unit of Measure: Units on a scale
-390.0
(-1307 to 783)
-299.5
(-1342 to 915)
4.Secondary Outcome
Title Changes in Biochemical Markers of Bone & Cartilage Metabolism.
Hide Description The central laboratory analyzed serum CTX-I (S-Crosslaps, Elecsys) and osteocalcin as well as urine CTX-I/creatinine and CTX-II/creatinine. It was originally planned that serum CTX-II would be measured, but this was not done.
Time Frame From Baseline to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. The number analyzed in some rows differs from the overall number analyzed due to missing values from patients who prematurely discontinued.
Arm/Group Title Active Arm Placebo Arm
Hide Arm/Group Description:
0.8mg SMC021 Oral Calcitonin tablet twice daily
1 SMC021 Placebo tablet twice daily
Overall Number of Participants Analyzed 585 584
Mean (Standard Deviation)
Unit of Measure: percentage of change
Serum CTX-I (ng/mL) Number Analyzed 578 participants 577 participants
41.358  (68.1153) 62.883  (65.7225)
Serum Osteocalcin (ng/mL) Number Analyzed 578 participants 577 participants
-9.134  (22.1368) 1.785  (22.8324)
24-h urine CTX-I/creatinine (µg/mmol) Number Analyzed 574 participants 571 participants
-8.959  (50.0723) 8.311  (55.4934)
24-h urine CTX-II/creatinine (ng/mmol) Number Analyzed 574 participants 571 participants
0.484  (56.4879) 11.266  (49.6250)
5.Secondary Outcome
Title Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months
Hide Description

To assess disease progression of OA affected joints, X-rays of both hands were performed & assessed by two central readers (at Synarc). Hand OA was assessed by calculating total score for osteophytes, cyst erosion, & joint space narrowing, each of which were based on sum of left and right hand X-ray analysis with possible scores of 0-66. The overall total score (possible range 0-198) was also used. Higher scores (closer to 66 or to 198 when using overall total score) imply a worse outcome. Hand analyses were based on double readings, and the mean was used in the analyses.

The AUStralian/CANadian Osteoarthritis Hand Index (AUSCAN) questionnaire was also used for assessment of hand OA. It measures pain (5 questions), stiffness (1 question) and difficulties with daily activities (9 questions) through a visual analogue scale (0-100mm; 0 = lowest score; 100 = highest score). Lower AUSCAN scores represent a better outcome. Change (from baseline to month 24) in these scores was calculated.

Time Frame Baseline and Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
About 15% of the ITT population had hand OA at baseline and only these subjects were included in the X-ray assessments.The AUSCAN questionnaire was administered to all the patients at sites in Denmark, the Czech Republic, and Romania.
Arm/Group Title Active Arm Placebo Arm
Hide Arm/Group Description:
0.8mg SMC021 Oral Calcitonin tablet twice daily
1 SMC021 Placebo tablet twice daily
Overall Number of Participants Analyzed 585 584
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Total osteophytes Number Analyzed 58 participants 64 participants
0.40  (0.784) 0.40  (0.754)
Total JSN Number Analyzed 58 participants 64 participants
0.45  (1.063) 0.62  (0.990)
Total cyst/erosions Number Analyzed 58 participants 64 participants
0.83  (1.204) 0.82  (1.327)
Total osteophytes, JSN and cyst/erosions Number Analyzed 58 participants 64 participants
1.68  (2.682) 1.84  (2.714)
AUSCAN total score Number Analyzed 297 participants 330 participants
-51.5  (265.13) -38.1  (272.07)
6.Secondary Outcome
Title Nature and # of AEs Monitored Continuously During Study
Hide Description Adverse events were by system organ class of all patients.
Time Frame From Baseline to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. A patient with multiple occurrences of a TEAE under one treatment is counted only once in the AE category for that treatment.
Arm/Group Title Active Arm Placebo Arm Total
Hide Arm/Group Description:
0.8mg SMC021 Oral Calcitonin tablet twice daily
1 SMC021 Placebo tablet twice daily
Total number of subjects between the two groups
Overall Number of Participants Analyzed 585 584 1169
Measure Type: Number
Unit of Measure: Number of AEs by system organ class
Any primary system organ class 548 520 1068
Blood and lymphatic system disorders 18 16 34
Cardiac disorders 38 30 68
Congenital, familial and genetic disorders 1 0 1
Ear and labyrinth disorders 14 12 26
Endocrine disorders 9 9 18
Eye disorders 17 22 39
Gastrointestinal disorders 268 150 418
General disorders and administration site condit. 60 53 113
Hepatobiliary disorders 11 10 21
Immune system disorders 8 4 12
Infections and infestations 231 249 480
Injury, poisoning and procedural complications 87 95 182
Investigations 53 53 106
Metabolism and nutrition disorders 76 64 140
Musculoskeletal and connective tissue disorders 231 267 498
Neoplasms benign, malignant and unspecified 27 16 43
Nervous system disorders 96 87 183
Psychiatric disorders 28 27 55
Renal and urinary disorders 19 14 33
Reproductive system and breast disorders 18 20 38
Respiratory, thoracic and mediastinal disorders 48 49 97
Skin and subcutaneous tissue disorders 69 36 105
Surgical and medical procedures 27 30 57
Vascular disorders 160 92 252
7.Secondary Outcome
Title Disease Progression in the Knee Evaluated by MRI.
Hide Description Disease progression in the signal knee (cartilage volume and thickness) were evaluated by magnetic resonance imaging (MRI). MRIs were performed for patients from the sites in Ballerup, Denmark, the Czech Republic, and Romania using a quality controlled low-field 0.18T C-Span scanner from Esaote dedicated to the imaging of extremities. The same solenoid coil was used for all patients at a given site.
Time Frame From Baseline to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
MRIs were performed for patients from the sites in Ballerup, Denmark, the Czech Republic, and Romania.
Arm/Group Title Active Arm Placebo Arm
Hide Arm/Group Description:
0.8mg SMC021 Oral Calcitonin tablet twice daily
1 SMC021 Placebo tablet twice daily
Overall Number of Participants Analyzed 268 261
Mean (Standard Deviation)
Unit of Measure: percentage of change
Total cartilage volume m12 Number Analyzed 194 participants 216 participants
2.90  (10.104) 0.26  (9.283)
Total cartilage volume m24 Number Analyzed 172 participants 203 participants
4.79  (10.352) 1.94  (9.257)
Total cartilage thickness m12 Number Analyzed 194 participants 216 participants
1.9921  (7.05068) 0.4343  (6.90177)
Total cartilage thickness m24 Number Analyzed 172 participants 203 participants
3.1777  (6.22356) 2.2467  (7.09590)
Time Frame From baseline until 30 days following the end of study.
Adverse Event Reporting Description The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
 
Arm/Group Title Active Arm Placebo Arm
Hide Arm/Group Description 0.8mg SMC021 Oral Calcitonin tablet twice daily 1 SMC021 Placebo tablet twice daily
All-Cause Mortality
Active Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   100/585 (17.09%)   88/584 (15.07%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/585 (0.17%)  1/584 (0.17%) 
Iron deficiency anaemia * 1  1/585 (0.17%)  0/584 (0.00%) 
Cardiac disorders     
Angina pectoris * 1  1/585 (0.17%)  2/584 (0.34%) 
Atrial fibrillation * 1  0/585 (0.00%)  3/584 (0.51%) 
Tachycardia * 1  2/585 (0.34%)  0/584 (0.00%) 
Sick sinus syndrome * 1  1/585 (0.17%)  1/584 (0.17%) 
Acute myocardial infarction * 1  1/585 (0.17%)  0/584 (0.00%) 
Angina unstable * 1  0/585 (0.00%)  1/584 (0.17%) 
Coronary artery dilatation * 1  0/585 (0.00%)  1/584 (0.17%) 
Coronary artery disease * 1  0/585 (0.00%)  1/584 (0.17%) 
Myocardial infarction * 1  1/585 (0.17%)  0/584 (0.00%) 
Myocardial ischaemia * 1  0/585 (0.00%)  1/584 (0.17%) 
Supraventricular tachycardia * 1  0/585 (0.00%)  1/584 (0.17%) 
Ear and labyrinth disorders     
Hypoacusis * 1  1/585 (0.17%)  0/584 (0.00%) 
Endocrine disorders     
Goitre * 1  1/585 (0.17%)  1/584 (0.17%) 
Hyperparathyroidism * 1  0/585 (0.00%)  1/584 (0.17%) 
Eye disorders     
Macular degeneration * 1  0/585 (0.00%)  1/584 (0.17%) 
Gastrointestinal disorders     
Haemorrhoids * 1  3/585 (0.51%)  0/584 (0.00%) 
Colonic polyp * 1  2/585 (0.34%)  0/584 (0.00%) 
Abdominal hernia * 1  0/585 (0.00%)  1/584 (0.17%) 
Abdominal pain * 1  1/585 (0.17%)  0/584 (0.00%) 
Anal fissure * 1  0/585 (0.00%)  1/584 (0.17%) 
Ascites * 1  1/585 (0.17%)  0/584 (0.00%) 
Diverticulum * 1  1/585 (0.17%)  0/584 (0.00%) 
Duodenal ulcer * 1  0/585 (0.00%)  1/584 (0.17%) 
Dyspepsia * 1  0/585 (0.00%)  1/584 (0.17%) 
Gastric ulcer * 1  1/585 (0.17%)  0/584 (0.00%) 
Gastritis erosive * 1  0/585 (0.00%)  1/584 (0.17%) 
Gastrooesophageal reflux disease * 1  0/585 (0.00%)  1/584 (0.17%) 
Haemorrhoidal haemorrhage * 1  1/585 (0.17%)  0/584 (0.00%) 
Inguinal hernia * 1  1/585 (0.17%)  0/584 (0.00%) 
Umbilical hernia * 1  1/585 (0.17%)  0/584 (0.00%) 
Volvulus * 1  1/585 (0.17%)  0/584 (0.00%) 
General disorders     
Chest pain * 1  1/585 (0.17%)  2/584 (0.34%) 
Accidental death * 1  0/585 (0.00%)  1/584 (0.17%) 
Device malfunction * 1  0/585 (0.00%)  1/584 (0.17%) 
Malaise * 1  1/585 (0.17%)  0/584 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis * 1  2/585 (0.34%)  2/584 (0.34%) 
Cholecystitis * 1  1/585 (0.17%)  0/584 (0.00%) 
Infections and infestations     
Diverticulitis * 1  2/585 (0.34%)  0/584 (0.00%) 
Gastroenteritis * 1  0/585 (0.00%)  2/584 (0.34%) 
Appendicitis * 1  1/585 (0.17%)  1/584 (0.17%) 
Anal abscess * 1  0/585 (0.00%)  1/584 (0.17%) 
Cystitis * 1  0/585 (0.00%)  1/584 (0.17%) 
Erysipelas * 1  1/585 (0.17%)  0/584 (0.00%) 
Lyme disease * 1  1/585 (0.17%)  0/584 (0.00%) 
Mastoiditis * 1  1/585 (0.17%)  0/584 (0.00%) 
Pneumonia * 1  1/585 (0.17%)  0/584 (0.00%) 
Post procedural infection * 1  0/585 (0.00%)  1/584 (0.17%) 
Pyelonephritis acute * 1  1/585 (0.17%)  0/584 (0.00%) 
Sepsis * 1  0/585 (0.00%)  1/584 (0.17%) 
Sinusitis * 1  1/585 (0.17%)  0/584 (0.00%) 
Urinary tract infection * 1  0/585 (0.00%)  1/584 (0.17%) 
Injury, poisoning and procedural complications     
Ankle fracture * 1  2/585 (0.34%)  0/584 (0.00%) 
Femur fracture * 1  0/585 (0.00%)  2/584 (0.34%) 
Hip fracture * 1  2/585 (0.34%)  0/584 (0.00%) 
Radius fracture * 1  0/585 (0.00%)  2/584 (0.34%) 
Wrist fracture * 1  2/585 (0.34%)  0/584 (0.00%) 
Concussion * 1  0/585 (0.00%)  1/584 (0.17%) 
Fall * 1  0/585 (0.00%)  1/584 (0.17%) 
Foot fracture * 1  1/585 (0.17%)  0/584 (0.00%) 
Foreign body * 1  1/585 (0.17%)  0/584 (0.00%) 
Hand fracture * 1  1/585 (0.17%)  0/584 (0.00%) 
Humerus fracture * 1  0/585 (0.00%)  1/584 (0.17%) 
Jaw fracture * 1  1/585 (0.17%)  0/584 (0.00%) 
Joint dislocation * 1  1/585 (0.17%)  0/584 (0.00%) 
Joint injury * 1  1/585 (0.17%)  0/584 (0.00%) 
Ligament rupture * 1  1/585 (0.17%)  0/584 (0.00%) 
Lower limb fracture * 1  0/585 (0.00%)  1/584 (0.17%) 
Meniscus lesion * 1  0/585 (0.00%)  1/584 (0.17%) 
Nerve injury * 1  1/585 (0.17%)  0/584 (0.00%) 
Post lumbar puncture syndrome * 1  1/585 (0.17%)  0/584 (0.00%) 
Procedural pain * 1  1/585 (0.17%)  0/584 (0.00%) 
Spinal compression fracture * 1  0/585 (0.00%)  1/584 (0.17%) 
Tendon rupture * 1  0/585 (0.00%)  1/584 (0.17%) 
Tibia fracture * 1  1/585 (0.17%)  0/584 (0.00%) 
Investigations     
Electrocardiogram T wave abnormal * 1  0/585 (0.00%)  1/584 (0.17%) 
Metabolism and nutrition disorders     
Obesity * 1  3/585 (0.51%)  0/584 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis * 1  11/585 (1.88%)  12/584 (2.05%) 
Spinal column stenosis * 1  5/585 (0.85%)  0/584 (0.00%) 
Intervertebral disc protrusion * 1  3/585 (0.51%)  1/584 (0.17%) 
Arthralgia * 1  2/585 (0.34%)  0/584 (0.00%) 
Back pain * 1  1/585 (0.17%)  1/584 (0.17%) 
Bursitis * 1  1/585 (0.17%)  1/584 (0.17%) 
Chondropathy * 1  0/585 (0.00%)  1/584 (0.17%) 
Foot deformity * 1  0/585 (0.00%)  1/584 (0.17%) 
Pain in extremity * 1  0/585 (0.00%)  1/584 (0.17%) 
Spondylolisthesis * 1  0/585 (0.00%)  1/584 (0.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer * 1  2/585 (0.34%)  2/584 (0.34%) 
Prostate cancer * 1  3/585 (0.51%)  0/584 (0.00%) 
Benign breast neoplasm * 1  0/585 (0.00%)  2/584 (0.34%) 
Bile duct cancer * 1  1/585 (0.17%)  0/584 (0.00%) 
Cervix carcinoma * 1  1/585 (0.17%)  0/584 (0.00%) 
Lung neoplasm malignant * 1  1/585 (0.17%)  0/584 (0.00%) 
Ovarian cancer * 1  1/585 (0.17%)  0/584 (0.00%) 
Rectal cancer * 1  1/585 (0.17%)  0/584 (0.00%) 
Squamous cell carcinoma * 1  1/585 (0.17%)  0/584 (0.00%) 
Uterine cancer * 1  1/585 (0.17%)  0/584 (0.00%) 
Uterine leimyoma * 1  1/585 (0.17%)  0/584 (0.00%) 
Nervous system disorders     
Cerebrovascular accident * 1  1/585 (0.17%)  3/584 (0.51%) 
Transient ischaemic attack * 1  1/585 (0.17%)  2/584 (0.34%) 
Cauda equina syndrome * 1  0/585 (0.00%)  1/584 (0.17%) 
Dizziness * 1  1/585 (0.17%)  0/584 (0.00%) 
Headache * 1  1/585 (0.17%)  0/584 (0.00%) 
Migraine * 1  1/585 (0.17%)  0/584 (0.00%) 
Radiculopathy * 1  0/585 (0.00%)  1/584 (0.17%) 
Sciatica * 1  1/585 (0.17%)  0/584 (0.00%) 
Psychiatric disorders     
Alcoholism * 1  0/585 (0.00%)  1/584 (0.17%) 
Renal and urinary disorders     
Urinary incontinence * 1  1/585 (0.17%)  1/584 (0.17%) 
Nephrolithiasis * 1  0/585 (0.00%)  1/584 (0.17%) 
Urethral prolapse * 1  0/585 (0.00%)  1/584 (0.17%) 
Urinary retension * 1  1/585 (0.17%)  0/584 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  1/585 (0.17%)  1/584 (0.17%) 
Prostatomegaly * 1  0/585 (0.00%)  1/584 (0.17%) 
Uterine haemorrhage * 1  1/585 (0.17%)  0/584 (0.00%) 
Vaginal prolapse * 1  0/585 (0.00%)  1/584 (0.17%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  0/585 (0.00%)  2/584 (0.34%) 
Pulmonary embolism * 1  1/585 (0.17%)  1/584 (0.17%) 
Interstitial lung disease * 1  1/585 (0.17%)  0/584 (0.00%) 
Nasal polyps * 1  1/585 (0.17%)  0/584 (0.00%) 
Pulmonary oedema * 1  1/585 (0.17%)  0/584 (0.00%) 
Respiratory failure * 1  0/585 (0.00%)  1/584 (0.17%) 
Skin and subcutaneous tissue disorders     
Peau d´orange * 1  0/585 (0.00%)  1/584 (0.17%) 
Rash * 1  0/585 (0.00%)  1/584 (0.17%) 
Surgical and medical procedures     
Bone graft * 1  4/585 (0.68%)  7/584 (1.20%) 
Knee arthroplasty * 1  2/585 (0.34%)  0/584 (0.00%) 
Abscess drainage * 1  1/585 (0.17%)  0/584 (0.00%) 
Appendicectomy * 1  0/585 (0.00%)  1/584 (0.17%) 
Cardial pacemaker insertion * 1  0/585 (0.00%)  1/584 (0.17%) 
Gastric bypass * 1  1/585 (0.17%)  0/584 (0.00%) 
Lipoma excision * 1  0/585 (0.00%)  1/584 (0.17%) 
Radical hysterectomy * 1  1/585 (0.17%)  0/584 (0.00%) 
Thyroidectomy * 1  0/585 (0.00%)  1/584 (0.17%) 
Vascular disorders     
Aortic aneurysm * 1  0/585 (0.00%)  1/584 (0.17%) 
Hypertension * 1  1/585 (0.17%)  0/584 (0.00%) 
Intermittent claudication * 1  1/585 (0.17%)  0/584 (0.00%) 
Circulatory collapse * 1  1/585 (0.17%)  0/584 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Active Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   548/585 (93.68%)   520/584 (89.04%) 
Gastrointestinal disorders     
Nausea * 1  82/585 (14.02%)  18/584 (3.08%) 
Dyspepsia * 1  59/585 (10.09%)  26/584 (4.45%) 
Diarrhoea * 1  56/585 (9.57%)  25/584 (4.28%) 
Abdominal pain upper * 1  26/585 (4.44%)  20/584 (3.42%) 
Abdominal pain * 1  12/585 (2.05%)  11/584 (1.88%) 
Constipation * 1  13/585 (2.22%)  7/584 (1.20%) 
Vomiting * 1  13/585 (2.22%)  5/584 (0.86%) 
Abdominal discomfort * 1  13/585 (2.22%)  4/584 (0.68%) 
General disorders     
Influenza like illness * 1  16/585 (2.74%)  12/584 (2.05%) 
Fatigue * 1  10/585 (1.71%)  14/584 (2.40%) 
Oedema peripheral * 1  10/585 (1.71%)  14/584 (2.40%) 
Infections and infestations     
Nasopharyngitis * 1  43/585 (7.35%)  55/584 (9.42%) 
Influenza * 1  36/585 (6.15%)  52/584 (8.90%) 
Cystitis * 1  35/585 (5.98%)  17/584 (2.91%) 
Pneumonia * 1  28/585 (4.79%)  24/584 (4.11%) 
Upper respiratory tract infection * 1  18/585 (3.08%)  19/584 (3.25%) 
Bronchitis * 1  15/585 (2.56%)  19/584 (3.25%) 
Sinusitis * 1  17/585 (2.91%)  15/584 (2.57%) 
Viral infections * 1  10/585 (1.71%)  21/584 (3.60%) 
Tooth infection * 1  19/585 (3.25%)  10/584 (1.71%) 
Gastroenteritis * 1  10/585 (1.71%)  14/584 (2.40%) 
Injury, poisoning and procedural complications     
Procedural pain * 1  29/585 (4.96%)  20/584 (3.42%) 
Contusion * 1  13/585 (2.22%)  11/584 (1.88%) 
Joint sprain * 1  8/585 (1.37%)  12/584 (2.05%) 
Metabolism and nutrition disorders     
Hypercholesterolemia * 1  30/585 (5.13%)  36/584 (6.16%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  89/585 (15.21%)  93/584 (15.92%) 
Back pain * 1  62/585 (10.60%)  59/584 (10.10%) 
Osteoarthritis * 1  36/585 (6.15%)  52/584 (8.90%) 
Pain in extremity * 1  38/585 (6.50%)  30/584 (5.14%) 
Musculoskeletal pain * 1  21/585 (3.59%)  30/584 (5.14%) 
Muscle spasms * 1  6/585 (1.03%)  16/584 (2.74%) 
Neck pain * 1  13/585 (2.22%)  9/584 (1.54%) 
Nervous system disorders     
Headache * 1  35/585 (5.98%)  28/584 (4.79%) 
Dizziness * 1  18/585 (3.08%)  25/584 (4.28%) 
Psychiatric disorders     
Depression * 1  14/585 (2.39%)  7/584 (1.20%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  16/585 (2.74%)  14/584 (2.40%) 
Skin and subcutaneous tissue disorders     
Erythema * 1  25/585 (4.27%)  3/584 (0.51%) 
Rash * 1  12/585 (2.05%)  6/584 (1.03%) 
Vascular disorders     
Hot flush * 1  104/585 (17.78%)  24/584 (4.11%) 
Hypertension * 1  46/585 (7.86%)  52/584 (8.90%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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: Bente Juel Riis, Medical Director
Organization: Nordic Bioscience A/S
Phone: +4522901317
EMail: bjr@nordicbioscience.com
Layout table for additonal information
Responsible Party: Nordic Bioscience A/S
ClinicalTrials.gov Identifier: NCT00486434     History of Changes
Other Study ID Numbers: CSMC021C2301
First Submitted: June 13, 2007
First Posted: June 14, 2007
Results First Submitted: March 28, 2012
Results First Posted: June 28, 2012
Last Update Posted: April 26, 2019