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Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis (SINCERE)

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ClinicalTrials.gov Identifier: NCT00688545
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : June 3, 2008
Results First Posted : July 19, 2013
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Arthritis, Juvenile Rheumatoid
Interventions Drug: Celecoxib
Drug: nsNSAIDs
Enrollment 275
Recruitment Details  
Pre-assignment Details A total of 275 people consented to participate in this study. One person should not have been enrolled and instead should have been a screen failure. This person did not receive any study drug.
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity. Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
Period Title: Overall Study
Started 55 219
Switched Treatment at Least Once 6 13
Completed 50 204
Not Completed 5 15
Reason Not Completed
Lost to Follow-up             1             4
Insurance/cost of drug             0             1
Withdrawal by Subject             2             3
Unspecified, unrelated to AE/Toxicity             2             7
Arm/Group Title Celecoxib nsNSAIDs Total
Hide Arm/Group Description Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity. Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity. Total of all reporting groups
Overall Number of Baseline Participants 55 219 274
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants 219 participants 274 participants
2-5 years 8 77 85
6-9 years 17 52 69
10-12 years 15 44 59
13-15 years 7 35 42
16-18 years 8 11 19
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 219 participants 274 participants
Female
47
  85.5%
165
  75.3%
212
  77.4%
Male
8
  14.5%
54
  24.7%
62
  22.6%
Juvenile Idiopathic Arthritis (JIA)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants 219 participants 274 participants
Systemic 0 3 3
Persistent Oligoarticular 27 119 146
Extended Oligoarticular 2 12 14
Poly RF- 23 70 93
Poly RF+ 3 14 17
Missing 0 1 1
[1]
Measure Description: Number of participants with JIA by subtype: systemic persistent oligoarticular, extended oligoarticular, polyarticular rheumatoid factor negative (Poly RF-) and positive (Poly RF+).
Gastrointestinal Symptom Scale for Kids (GISSK) - Type of stomach problems   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants 219 participants 274 participants
Heartburn 9 21 30
Upper stomach pain 8 18 26
Lower stomach pain 16 34 50
Nausea 14 32 46
Diarrhea 5 18 23
Constipation 5 16 21
Vomiting 2 8 10
Poor appetite 7 13 20
No problems 23 132 155
Missing 1 3 4
[1]
Measure Description: Participant or caregiver reported severity of participant's stomach problems during the last week using visual analogue scale (VAS), scores ranged from 0 (no trouble at all) to 100 (severe stomach problems). Also identified types of participant's stomach problems, if any, during the last week by selecting one or more check boxes.
JIA medications   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants 219 participants 274 participants
Gastrointestinal (GI) protective agents 18 48 66
Other GI 4 4 8
Disease-modifying antirheumatic drugs (DMARDs) 21 83 104
Biologics 8 28 36
Antihypertensives 1 4 5
NSAIDs (Celecoxib) 8 0 8
NSAIDs (Diclofenac) 0 0 0
NSAIDs (Ibuprofen) 2 7 9
NSAIDs (Meloxicam) 0 6 6
NSAIDs (Naproxen) 0 16 16
NSAIDs (Other) 0 5 5
Corticosteroids (Oral, IV, Intra-Articular) 5 19 24
Corticosteroids (Other) 2 3 5
Analgesics (Acetaminophen, Opioids, Other) 9 18 27
[1]
Measure Description: JIA medications by class: GI protective agents (eg, proton-pump inhibitors), other GI, DMARDs, biologics, antihypertensives, NSAIDs (Celecoxib, Diclofenac, Ibuprofen, Meloxicam, Naproxen, other), corticosteroids (oral, intravenous [IV], intra-articular, other forms), analgesics (eg, Acetaminophen). Participants could receive more than 1 medication.
Number of participants with abnormal physical exam results   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants 219 participants 274 participants
17 63 80
[1]
Measure Description: Abnormal findings in physical examination as determined by physician
Physician Global Assessment (PGA) of Disease Activity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 55 participants 219 participants 274 participants
2.6  (2.36) 2.9  (2.19) 2.8  (2.22)
[1]
Measure Description: PGA measured on a scale from 0 (not active) to 10 (very active) where higher scores indicated more disease activity.
Participant or caregiver's assessment of participant's overall well-being   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 55 participants 219 participants 274 participants
3.2  (2.58) 2.8  (2.50) 2.9  (2.52)
[1]
Measure Description: Overall well being measured on a scale from 0 (very well) to 10 (very poor).
Child Health Questionnaire (CHAQ) - global evaluation   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 55 participants 219 participants 274 participants
29.11  (29.34) 20.15  (21.58) 21.96  (23.56)
[1]
Measure Description: CHAQ: validated parent or legal guardian assessed instrument of child's activities of daily living, pain, and global assessment. Global evaluation rated on a visual analog scale (VAS) from 0 (very well) to 100 (very poor) where higher scores indicated a worse evaluation.
CHAQ - pain   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 55 participants 219 participants 274 participants
0.92  (0.85) 0.71  (0.72) 0.75  (0.75)
[1]
Measure Description: CHAQ: validated parent or legal guardian assessed instrument of child's activities of daily living, pain, and global assessment. Pain rated on a VAS from 0 (no pain) to 100 (severe pain). Scores converted to 0, 1, 2, or 3 where 0 = no pain and 3 = severe pain.
CHAQ - functioning   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 55 participants 219 participants 274 participants
0.65  (0.68) 0.48  (0.54) 0.52  (0.57)
[1]
Measure Description: Daily functioning included questions on level of difficulty child had with 8 categories of daily living. Responses ranged from 'without any difficulty' (0) to 'unable to do' (3). Functioning score = sum of highest score in each category divided by number of categories answered; scores ranged from 0 to 3; higher scores indicated more impairment.
Number of joints with active arthritis   [1] 
Mean (Standard Deviation)
Unit of measure:  Joints
Number Analyzed 55 participants 219 participants 274 participants
3.4  (5.39) 2.9  (4.14) 3.0  (4.42)
[1]
Measure Description: Active arthritis defined as swelling or limitation of motion of the joint accompanied by heat, pain, or tenderness. A total of 36 joints and spine (cervical, thoracic, and lumbar) checked.
GISSK - severity of stomach problems   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 55 participants 219 participants 274 participants
21.9  (25.75) 12.0  (19.84) 14.0  (21.47)
[1]
Measure Description: GISSK is a validated measure of GI symptom severity and types of GI problems, if any. For severity of stomach problems, participant or caregiver reported severity of participant's stomach problems during the last week using VAS, where scores ranged from 0 (no trouble at all) to 100 (severe stomach problems).
Body weight  
Median (Full Range)
Unit of measure:  Kilogram (kg)
Number Analyzed 55 participants 219 participants 274 participants
33.60
(10.7 to 67.4)
30.20
(8.7 to 99.5)
30.90
(8.7 to 99.5)
Height  
Median (Full Range)
Unit of measure:  Centimeters (cm)
Number Analyzed 55 participants 219 participants 274 participants
141.30
(81.2 to 174.5)
130.10
(77.5 to 179.0)
132.00
(77.5 to 179.0)
Body Mass Index (BMI)   [1] 
Median (Full Range)
Unit of measure:  Kilograms per meter squared (kg/m^2)
Number Analyzed 55 participants 219 participants 274 participants
17.70
(7.4 to 28.6)
17.31
(12.5 to 45.1)
17.55
(7.4 to 45.1)
[1]
Measure Description: Based on World Health Organization (WHO) 2000 Centers for Disease Control growth charts. BMI = Weight in Kilograms divided by (/) (Height in Meters multipled by [*] Height in Meters).
Weight and Height percentiles overall   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentile
Number Analyzed 55 participants 219 participants 274 participants
Weight 47.22  (29.95) 56.68  (30.96) 54.76  (30.94)
Height 42.77  (29.59) 50.70  (30.76) 49.08  (30.63)
[1]
Measure Description: Percentile category based on WHO 2000 Centers for Disease Control growth charts
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. AEs attributed to the NSAID (celecoxib or nsNSAID) utilized at time of event, regardless of the initial NSAID treatment at Registry entry.
Time Frame Baseline up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants who were prescribed at least one dose of any NSAID. Participants who switched treatment were counted for the NSAID utilized at the time of the event, regardless of the initial NSAID treatment at enrollment.
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
Participants who received celecoxib at any time during the study. Treatment assignment as per treating physician's judgment. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
Participants who received nsNSAIDs at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for nsNSAIDs took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
Overall Number of Participants Analyzed 68 225
Measure Type: Number
Unit of Measure: Participants
AEs 36 117
SAEs 2 9
2.Primary Outcome
Title JIA Concomitant Medications
Hide Description JIA medications by class: GI protective agents (eg, proton-pump inhibitors, antacids, surcalfate), other GI, DMARDs, biologics, antihypertensives, NSAIDs (Celecoxib, Diclofenac, Ibuprofen, Meloxicam, Naproxen, other NSAIDs), corticosteroids (oral, IV, intra-articular, other forms), analgesics Acetaminophen, Opioids, other). Participants could receive more than 1 medication.
Time Frame Year 2 or early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set subset of participants who received JIA concomitant medications
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description:
Participants who were prescribed celecoxib at baseline per treating physician's judgment. Participants could switch to nonselective non-steroidal anti-inflammatory drugs (nsNSAIDs) at any time during the study. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity
Participants who were prescribed nsNSAIDs at baseline per treating physician's judgment. Any nsNSAID could be used at the discretion of the investigator, provided that the medicine was not contraindicated for the participant as per the current United States product information for that nsNSAID. Participants could switch to other nsNSAIDs or celecoxib at any time during the study. The use and dosage recommendations for study drug took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
Overall Number of Participants Analyzed 39 148
Measure Type: Number
Unit of Measure: Participants
GI protective agents 20 54
Other GI 5 8
DMARDs 24 102
Biologics 13 60
Antihypertensives 1 4
NSAIDs (Celecoxib) 7 2
NSAIDs (Diclofenac) 0 0
NSAIDs (Ibuprofen) 1 9
NSAIDs (Meloxicam) 1 8
NSAIDs (Naproxen) 0 7
NSAIDs (Other) 0 3
Corticosteroids (oral, IV, intra-articular) 4 15
Corticosteroids (Other) 2 6
Analgesics (Acetaminophen, Opioids, Other) 11 19
Time Frame [Not Specified]
Adverse Event Reporting Description Participants who switched treatment were counted for NSAID utilized at time of event, regardless of initial NSAID treatment at enrollment. The same event may appear as both an AE and SAE. However, distinct events are presented.
 
Arm/Group Title Celecoxib nsNSAIDs
Hide Arm/Group Description Participants who were prescribed celecoxib at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for celecoxib took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity. Participants who received nsNSAIDs at any time during the study. Treatment assignment per treating physician's judgment. The use and dosage recommendations for nsNSAIDs took place on the basis of the approved Product Label and were adjusted solely according to medical and therapeutic necessity.
All-Cause Mortality
Celecoxib nsNSAIDs
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Celecoxib nsNSAIDs
Affected / at Risk (%) Affected / at Risk (%)
Total   2/68 (2.94%)   9/225 (4.00%) 
Blood and lymphatic system disorders     
Febrile Neutropenia * 1  0/68 (0.00%)  1/225 (0.44%) 
Agranulocytosis * 1  0/68 (0.00%)  1/225 (0.44%) 
Gastrointestinal disorders     
Abdominal Pain Lower * 1  0/68 (0.00%)  1/225 (0.44%) 
General disorders     
Condition Aggravated * 1  1/68 (1.47%)  0/225 (0.00%) 
Pyrexia * 1  1/68 (1.47%)  0/225 (0.00%) 
Infections and infestations     
Cellulitis * 1  1/68 (1.47%)  1/225 (0.44%) 
Appendicitis * 1  0/68 (0.00%)  1/225 (0.44%) 
Arthritis Bacterial * 1  0/68 (0.00%)  1/225 (0.44%) 
Meningitis * 1  0/68 (0.00%)  1/225 (0.44%) 
Musculoskeletal and connective tissue disorders     
Juvenile Arthritis * 1  0/68 (0.00%)  1/225 (0.44%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Fibrous Histiocytoma * 1  0/68 (0.00%)  1/225 (0.44%) 
Nervous system disorders     
Migraine * 1  1/68 (1.47%)  0/225 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Unintended Pregnancy * 1  0/68 (0.00%)  1/225 (0.44%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA unspecified
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Celecoxib nsNSAIDs
Affected / at Risk (%) Affected / at Risk (%)
Total   35/68 (51.47%)   114/225 (50.67%) 
Blood and lymphatic system disorders     
Lymphadenopathy * 1  1/68 (1.47%)  1/225 (0.44%) 
Anaemia * 1  0/68 (0.00%)  1/225 (0.44%) 
Leukopenia * 1  0/68 (0.00%)  1/225 (0.44%) 
Lymphopenia * 1  0/68 (0.00%)  1/225 (0.44%) 
Cardiac disorders     
Tachycardia * 1  1/68 (1.47%)  0/225 (0.00%) 
Congenital, familial and genetic disorders     
Micrognathia * 1  1/68 (1.47%)  0/225 (0.00%) 
Eye disorders     
Uveitis * 1  0/68 (0.00%)  6/225 (2.67%) 
Chalazion * 1  0/68 (0.00%)  1/225 (0.44%) 
Conjunctivitis * 1  0/68 (0.00%)  1/225 (0.44%) 
Dry eye * 1  0/68 (0.00%)  1/225 (0.44%) 
Eye Pain * 1  0/68 (0.00%)  1/225 (0.44%) 
Hypermetropia * 1  0/68 (0.00%)  1/225 (0.44%) 
Vision Blurred * 1  0/68 (0.00%)  1/225 (0.44%) 
Gastrointestinal disorders     
Nausea * 1  11/68 (16.18%)  28/225 (12.44%) 
Abdominal pain * 1  9/68 (13.24%)  27/225 (12.00%) 
Diarrhoea * 1  2/68 (2.94%)  16/225 (7.11%) 
Vomiting * 1  5/68 (7.35%)  8/225 (3.56%) 
Abdominal Pain Upper * 1  3/68 (4.41%)  9/225 (4.00%) 
Constipation * 1  2/68 (2.94%)  9/225 (4.00%) 
Dyspepsia * 1  3/68 (4.41%)  8/225 (3.56%) 
Abdominal Pain Lower * 1  1/68 (1.47%)  6/225 (2.67%) 
Gastrooesophageal Reflux Disease * 1  0/68 (0.00%)  6/225 (2.67%) 
Stomatitis * 1  2/68 (2.94%)  4/225 (1.78%) 
Mouth Ulceration * 1  1/68 (1.47%)  2/225 (0.89%) 
Abdominal Distension * 1  1/68 (1.47%)  1/225 (0.44%) 
Dry Mouth * 1  0/68 (0.00%)  2/225 (0.89%) 
Faeces Discoloured * 1  1/68 (1.47%)  1/225 (0.44%) 
Faeces Hard * 1  0/68 (0.00%)  2/225 (0.89%) 
Coeliac Disease * 1  1/68 (1.47%)  0/225 (0.00%) 
Crohn's Disease * 1  0/68 (0.00%)  1/225 (0.44%) 
Gastritis * 1  0/68 (0.00%)  1/225 (0.44%) 
Inguinal Hernia * 1  0/68 (0.00%)  1/225 (0.44%) 
Oesophagitis * 1  1/68 (1.47%)  0/225 (0.00%) 
General disorders     
Disease Progression * 1  2/68 (2.94%)  5/225 (2.22%) 
Pyrexia * 1  0/68 (0.00%)  4/225 (1.78%) 
Chest Pain * 1  2/68 (2.94%)  0/225 (0.00%) 
Drug Intolerance * 1  0/68 (0.00%)  2/225 (0.89%) 
Fatigue * 1  0/68 (0.00%)  2/225 (0.89%) 
Irritability * 1  0/68 (0.00%)  1/225 (0.44%) 
Mucosal Inflammation * 1  0/68 (0.00%)  1/225 (0.44%) 
Immune system disorders     
Drug Hypersensitivity * 1  0/68 (0.00%)  1/225 (0.44%) 
Hypersensitivity * 1  0/68 (0.00%)  1/225 (0.44%) 
Latex Allergy * 1  0/68 (0.00%)  1/225 (0.44%) 
Seasonal Allergy * 1  0/68 (0.00%)  1/225 (0.44%) 
Infections and infestations     
Upper Respiratory Tract Infection * 1  1/68 (1.47%)  7/225 (3.11%) 
Pharyngitis Streptococcal * 1  1/68 (1.47%)  5/225 (2.22%) 
Pneumonia * 1  2/68 (2.94%)  2/225 (0.89%) 
Sinusitis * 1  1/68 (1.47%)  3/225 (1.33%) 
Ear Infection * 1  1/68 (1.47%)  2/225 (0.89%) 
Influenza * 1  2/68 (2.94%)  1/225 (0.44%) 
Otitis Media * 1  1/68 (1.47%)  2/225 (0.89%) 
Pharyngitis * 1  2/68 (2.94%)  1/225 (0.44%) 
Viral Infection * 1  1/68 (1.47%)  2/225 (0.89%) 
Fungal Skin Infection * 1  1/68 (1.47%)  1/225 (0.44%) 
Gastroenteritis * 1  0/68 (0.00%)  2/225 (0.89%) 
Tonsillitis * 1  0/68 (0.00%)  2/225 (0.89%) 
Adenoiditis * 1  0/68 (0.00%)  1/225 (0.44%) 
Bronchitis * 1  0/68 (0.00%)  1/225 (0.44%) 
Cellulitis * 1  0/68 (0.00%)  1/225 (0.44%) 
Chronic Tonsillitis * 1  1/68 (1.47%)  0/225 (0.00%) 
Conjunctivitis Infective * 1  0/68 (0.00%)  1/225 (0.44%) 
Coxsackie Viral Infection * 1  0/68 (0.00%)  1/225 (0.44%) 
Cystitis * 1  0/68 (0.00%)  1/225 (0.44%) 
Erythema Infectiosum * 1  0/68 (0.00%)  1/225 (0.44%) 
Eye Infection Bacterial * 1  0/68 (0.00%)  1/225 (0.44%) 
Eye Infection Viral * 1  0/68 (0.00%)  1/225 (0.44%) 
Fungal Infection * 1  0/68 (0.00%)  1/225 (0.44%) 
Furuncle * 1  0/68 (0.00%)  1/225 (0.44%) 
Gastroenteritis Viral * 1  0/68 (0.00%)  1/225 (0.44%) 
Impetigo * 1  0/68 (0.00%)  1/225 (0.44%) 
Infection * 1  1/68 (1.47%)  0/225 (0.00%) 
Molluscum Contagiosum * 1  0/68 (0.00%)  1/225 (0.44%) 
Onychomycosis * 1  0/68 (0.00%)  1/225 (0.44%) 
Otitis Externa * 1  0/68 (0.00%)  1/225 (0.44%) 
Paronychia * 1  0/68 (0.00%)  1/225 (0.44%) 
Rash Pustular * 1  0/68 (0.00%)  1/225 (0.44%) 
Staphylococcal Infection * 1  0/68 (0.00%)  1/225 (0.44%) 
Streptococcal Infection * 1  0/68 (0.00%)  1/225 (0.44%) 
Subcutaneous Abscess * 1  0/68 (0.00%)  1/225 (0.44%) 
Tonsillitis Streptococcal * 1  0/68 (0.00%)  1/225 (0.44%) 
Urinary Tract Infection * 1  0/68 (0.00%)  1/225 (0.44%) 
Injury, poisoning and procedural complications     
Contusion * 1  0/68 (0.00%)  6/225 (2.67%) 
Arthropod Bite * 1  0/68 (0.00%)  2/225 (0.89%) 
Lower Limb Fracture * 1  0/68 (0.00%)  1/225 (0.44%) 
Investigations     
Weight Decreased * 1  1/68 (1.47%)  1/225 (0.44%) 
Blood Pressure Increased * 1  0/68 (0.00%)  1/225 (0.44%) 
Blood Urea Increased * 1  0/68 (0.00%)  1/225 (0.44%) 
C-reactive Protein Increased * 1  0/68 (0.00%)  1/225 (0.44%) 
Hepatic Enzyme Increased * 1  0/68 (0.00%)  1/225 (0.44%) 
Red Blood Cell Sedimentation Rate Increased * 1  0/68 (0.00%)  1/225 (0.44%) 
Weight Increased * 1  0/68 (0.00%)  1/225 (0.44%) 
Metabolism and nutrition disorders     
Anorexia * 1  3/68 (4.41%)  10/225 (4.44%) 
Decreased Appetite * 1  0/68 (0.00%)  1/225 (0.44%) 
Musculoskeletal and connective tissue disorders     
Arthritis * 1  0/68 (0.00%)  3/225 (1.33%) 
Back Pain * 1  0/68 (0.00%)  3/225 (1.33%) 
Arthralgia * 1  0/68 (0.00%)  1/225 (0.44%) 
Growth Retardation * 1  0/68 (0.00%)  1/225 (0.44%) 
Joint Effusion * 1  0/68 (0.00%)  1/225 (0.44%) 
Muscle Atrophy * 1  0/68 (0.00%)  1/225 (0.44%) 
Muscle Spasms * 1  0/68 (0.00%)  1/225 (0.44%) 
Osteoporosis * 1  0/68 (0.00%)  1/225 (0.44%) 
Synovial Cyst * 1  0/68 (0.00%)  1/225 (0.44%) 
Unequal Limb Length * 1  1/68 (1.47%)  0/225 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lipoma * 1  1/68 (1.47%)  0/225 (0.00%) 
Nervous system disorders     
Headache * 1  3/68 (4.41%)  9/225 (4.00%) 
Dizziness * 1  0/68 (0.00%)  3/225 (1.33%) 
Convulsion * 1  0/68 (0.00%)  2/225 (0.89%) 
Cognitive Disorder * 1  0/68 (0.00%)  1/225 (0.44%) 
Disturbance In Attention * 1  0/68 (0.00%)  1/225 (0.44%) 
Dysgeusia * 1  0/68 (0.00%)  1/225 (0.44%) 
Dyskinesia * 1  1/68 (1.47%)  0/225 (0.00%) 
Memory Impairment * 1  0/68 (0.00%)  1/225 (0.44%) 
Migraine * 1  0/68 (0.00%)  1/225 (0.44%) 
Paraesthesia * 1  0/68 (0.00%)  1/225 (0.44%) 
Psychomotor Hyperactivity * 1  0/68 (0.00%)  1/225 (0.44%) 
Tremor * 1  0/68 (0.00%)  1/225 (0.44%) 
Psychiatric disorders     
Attention Deficit/Hyperactivity Disorder * 1  0/68 (0.00%)  1/225 (0.44%) 
Confusional State * 1  0/68 (0.00%)  1/225 (0.44%) 
Initial Insomnia * 1  1/68 (1.47%)  0/225 (0.00%) 
Insomnia * 1  0/68 (0.00%)  1/225 (0.44%) 
Mood Altered * 1  0/68 (0.00%)  1/225 (0.44%) 
Sleep Disorder * 1  0/68 (0.00%)  1/225 (0.44%) 
Renal and urinary disorders     
Haematuria * 1  0/68 (0.00%)  3/225 (1.33%) 
Urinary Incontinence * 1  1/68 (1.47%)  1/225 (0.44%) 
Dysuria * 1  1/68 (1.47%)  0/225 (0.00%) 
Proteinuria * 1  1/68 (1.47%)  0/225 (0.00%) 
Reproductive system and breast disorders     
Menstruation Irregular * 1  0/68 (0.00%)  1/225 (0.44%) 
Vaginal Discharge * 1  1/68 (1.47%)  0/225 (0.00%) 
Vulval Disorder * 1  1/68 (1.47%)  0/225 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma Exercise Induced * 1  0/68 (0.00%)  1/225 (0.44%) 
Cough * 1  0/68 (0.00%)  1/225 (0.44%) 
Dyspnoea * 1  0/68 (0.00%)  1/225 (0.44%) 
Dyspnoea Exertional * 1  0/68 (0.00%)  1/225 (0.44%) 
Oropharyngeal Pain * 1  0/68 (0.00%)  1/225 (0.44%) 
Pleuritic Pain * 1  0/68 (0.00%)  1/225 (0.44%) 
Postnasal Drip * 1  0/68 (0.00%)  1/225 (0.44%) 
Rhinitis Allergic * 1  0/68 (0.00%)  1/225 (0.44%) 
Tonsillar Hypertrophy * 1  0/68 (0.00%)  1/225 (0.44%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  1/68 (1.47%)  4/225 (1.78%) 
Rash * 1  3/68 (4.41%)  2/225 (0.89%) 
Eczema * 1  0/68 (0.00%)  3/225 (1.33%) 
Pseudoporphyria * 1  0/68 (0.00%)  3/225 (1.33%) 
Urticaria * 1  0/68 (0.00%)  2/225 (0.89%) 
Dry Skin * 1  0/68 (0.00%)  1/225 (0.44%) 
Ecchymosis * 1  0/68 (0.00%)  1/225 (0.44%) 
Erythema Multiforme * 1  0/68 (0.00%)  1/225 (0.44%) 
Keratosis Pilaris * 1  0/68 (0.00%)  1/225 (0.44%) 
Pruritus * 1  1/68 (1.47%)  0/225 (0.00%) 
Rash Erythematous * 1  0/68 (0.00%)  1/225 (0.44%) 
Rash Papular * 1  1/68 (1.47%)  0/225 (0.00%) 
Rash Pruritic * 1  0/68 (0.00%)  1/225 (0.44%) 
Seborrhoea * 1  0/68 (0.00%)  1/225 (0.44%) 
Skin Exfoliation * 1  0/68 (0.00%)  1/225 (0.44%) 
Swelling Face * 1  0/68 (0.00%)  1/225 (0.44%) 
Vitiligo * 1  0/68 (0.00%)  1/225 (0.44%) 
Surgical and medical procedures     
Joint Arthroplasty * 1  1/68 (1.47%)  0/225 (0.00%) 
Vascular disorders     
Flushing * 1  0/68 (0.00%)  1/225 (0.44%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA unspecified
Study terminated prematurely: Sponsor released by FDA from post-marketing commitment. As a result, only a small number of participants/analyses could be performed, data must be interpreted with caution. Endpoints arbitrarily assigned as primary.
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
ClinicalTrials.gov Identifier: NCT00688545    
Other Study ID Numbers: A3191344
First Submitted: May 29, 2008
First Posted: June 3, 2008
Results First Submitted: May 7, 2013
Results First Posted: July 19, 2013
Last Update Posted: February 2, 2021