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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
| Conditions: |
Osteoarthritis, Knee Osteoarthritis, Hip |
| Intervention: |
Drug: Celecoxib |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 111 centers in the Americas and Europe enrolled and treated subjects (2 centers in Belgium, 4 centers in Brazil, 20 centers in Canada, 5 centers in Chile, 5 centers in Columbia, 1 center in France, 15 centers in the United Kingdom, and 59 centers in the United States). |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| 17 participants completed Open-label run-in Period II and were randomized to Period III Double Blind but not treated. |
| Description | |
|---|---|
| Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories | Period I (14+/-2 days) wash out and discontinuation of non-steroidal anti-inflammatories (NSAIDs) leading to osteoarthritis (OA) flare. |
| Open-Label Celecoxib Run-in Period | Period II (14+/-2 days) run-in treatment with open label celecoxib to observe successful treatment of flare. Participants successfully treated randomized to 2 treatment groups in Period III (overall study). |
| Celecoxib 200mg Continuous Use | Period III Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed. |
| Celecoxib 200mg Intermittent Use | Period III Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed. |
| Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories | Open-Label Celecoxib Run-in Period | Celecoxib 200mg Continuous Use | Celecoxib 200mg Intermittent Use | |
|---|---|---|---|---|
| STARTED | 1772 | 0 | 0 | 0 |
| COMPLETED | 1197 | 0 | 0 | 0 |
| NOT COMPLETED | 575 | 0 | 0 | 0 |
| Did not enter Period II | 575 | 0 | 0 | 0 |
| Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories | Open-Label Celecoxib Run-in Period | Celecoxib 200mg Continuous Use | Celecoxib 200mg Intermittent Use | |
|---|---|---|---|---|
| STARTED | 0 | 1197 | 0 | 0 |
| COMPLETED | 0 | 875 | 0 | 0 |
| NOT COMPLETED | 0 | 322 | 0 | 0 |
| Not Randomized into Period III | 0 | 322 | 0 | 0 |
| Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories | Open-Label Celecoxib Run-in Period | Celecoxib 200mg Continuous Use | Celecoxib 200mg Intermittent Use | |
|---|---|---|---|---|
| STARTED | 0 | 0 | 431[1] | 427[2] |
| COMPLETED | 0 | 0 | 355 | 321 |
| NOT COMPLETED | 0 | 0 | 76 | 106 |
| Adverse Event | 0 | 0 | 22 | 23 |
| Unknown | 0 | 0 | 23 | 34 |
| Lack of Efficacy | 0 | 0 | 10 | 24 |
| Lost to Follow-up | 0 | 0 | 5 | 4 |
| Withdrawal by Subject | 0 | 0 | 16 | 21 |
| [1] | Randomized 440: 9 participants not treated |
|---|---|
| [2] | Randomized 435: 8 participants not treated |
Baseline Characteristics
| Description | |
|---|---|
| Celecoxib 200mg Continuous Use | Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed. |
| Celecoxib 200mg Intermittent Use | Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed. |
| Celecoxib 200mg Continuous Use | Celecoxib 200mg Intermittent Use | Total | |
|---|---|---|---|
|
Number of Participants [units: participants] |
431 | 427 | 858 |
|
Age [units: years] Mean ± Standard Deviation |
58.5 ± 10.00 | 58.7 ± 9.6 | 58.6 ± 9.8 |
|
Gender [units: participants] |
|||
| Female | 317 | 303 | 620 |
| Male | 114 | 124 | 238 |
Outcome Measures
| 1. Primary: | Number of Flare Events Per Time of Exposure to Study Medication [ Period III (22 weeks) ] |
| 2. Secondary: | Time to Occurrence of First Osteoarthritis (OA) Flare [ Period III (22 weeks) ] |
| 3. Secondary: | Proportion of Days Free From Osteoarthritis (OA) Flare [ Period III (22 weeks) ] |
| 4. Secondary: | Proportion of Days in Osteoarthritis (OA) Flare [ Period III (22 weeks) ] |
| 5. Secondary: | Arthritis Pain Numerical Rating Scale (NRS) [ Period III ] |
| 6. Secondary: | Patient's Global Assessment of Arthritis [ Period III ] |
| 7. Secondary: | Physician's Global Assessment of Arthritis at Final Visit [ Period III (22 weeks) ] |
| 8. Secondary: | Total Rescue Medication Taken (Mean) [ Period III (22 weeks) ] |
| 9. Secondary: | Proportion of Days on Rescue Medication [ Period III (22 weeks) ] |
| 10. Secondary: | Days on Flare Medication [ Period III (22 weeks) ] |
| 11. Secondary: | Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores [ Period III (22 weeks) ] |
| 12. Secondary: | Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores [ Period III (22 weeks) ] |
| 13. Other Pre-specified: | Change in Medical Outcomes Study Sleep Scale - All Assessments [ Period III ] |
| 14. Other Pre-specified: | Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep [ Period III ] |
| 15. Other Pre-specified: | Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments [ Period III ] |
| 16. Other Pre-specified: | Serious Adverse Events in Open Label run-in Period [ 2 weeks prior to double blind dosing ] |
Serious Adverse Events Other Adverse Events
| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
| Threshold above which other adverse events are reported | 0% |
|---|
| Description | |
|---|---|
| Celecoxib 200mg Continuous Use | Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed. |
| Celecoxib 200mg Intermittent Use | Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed. |
| Celecoxib 200mg Continuous Use | Celecoxib 200mg Intermittent Use | |
|---|---|---|
| Total, other (not including serious) adverse events | ||
| # participants affected | 242 | 246 |
| Blood and lymphatic system disorders | ||
| Anaemia † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Lymphadenopathy † A # participants affected / at risk |
1/431 (0.23%) |
2/427 (0.47%) |
| Cardiac disorders | ||
| Angina pectoris † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Bundle branch block left † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Extrasystoles † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Hypertensive heart disease † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Sinus tachycardia † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Tachycardia † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Ear and labyrinth disorders | ||
| Cerumen impaction † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Deafness † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Ear disorder † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Ear pain † A # participants affected / at risk |
2/431 (0.46%) |
2/427 (0.47%) |
| Eustachian tube dysfunction † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Tympanic membrane disorder † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Vertigo † A # participants affected / at risk |
5/431 (1.16%) |
3/427 (0.70%) |
| Endocrine disorders | ||
| Goitre † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Hypothyroidism † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Eye disorders | ||
| Cataract † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Conjunctivitis † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Conjunctivitis allergic † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Diplopia † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Dry eye † A # participants affected / at risk |
2/431 (0.46%) |
0/427 (0.00%) |
| Eye allergy † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Eye irritation † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Glaucoma † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Lacrimation increased † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Myodesopsia † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Vision blurred † A # participants affected / at risk |
2/431 (0.46%) |
1/427 (0.23%) |
| Visual acuity reduced † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Gastrointestinal disorders | ||
| Abdominal discomfort † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Abdominal distension † A # participants affected / at risk |
3/431 (0.70%) |
1/427 (0.23%) |
| Abdominal hernia † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Abdominal pain † A # participants affected / at risk |
10/431 (2.32%) |
3/427 (0.70%) |
| Abdominal pain lower † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Abdominal pain upper † A # participants affected / at risk |
7/431 (1.62%) |
10/427 (2.34%) |
| Aphthous stomatitis † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Breath odour † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Colitis † A # participants affected / at risk |
1/431 (0.23%) |
2/427 (0.47%) |
| Constipation † A # participants affected / at risk |
5/431 (1.16%) |
4/427 (0.94%) |
| Dental caries † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Diarrhoea † A # participants affected / at risk |
7/431 (1.62%) |
17/427 (3.98%) |
| Dry mouth † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Dyspepsia † A # participants affected / at risk |
17/431 (3.94%) |
6/427 (1.41%) |
| Eructation † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Flatulence † A # participants affected / at risk |
2/431 (0.46%) |
0/427 (0.00%) |
| Frequent bowel movements † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Gastritis † A # participants affected / at risk |
5/431 (1.16%) |
2/427 (0.47%) |
| Gastrooesophageal reflux disease † A # participants affected / at risk |
4/431 (0.93%) |
3/427 (0.70%) |
| Gastrooesophagitis † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Gingival pain † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Haematochezia † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Haemorrhoids † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Inguinal hernia † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Irritable bowel syndrome † A # participants affected / at risk |
3/431 (0.70%) |
3/427 (0.70%) |
| Mouth ulceration † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Nausea † A # participants affected / at risk |
5/431 (1.16%) |
9/427 (2.11%) |
| Oral pain † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Paraesthesia oral † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Parotid gland enlargement † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Peptic ulcer † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Proctitis † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Rectal haemorrhage † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Stomach discomfort † A # participants affected / at risk |
4/431 (0.93%) |
1/427 (0.23%) |
| Stomatitis † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Tongue disorder † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Toothache † A # participants affected / at risk |
3/431 (0.70%) |
6/427 (1.41%) |
| Vomiting † A # participants affected / at risk |
5/431 (1.16%) |
6/427 (1.41%) |
| General disorders | ||
| Asthenia † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Chest discomfort † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Chest pain † A # participants affected / at risk |
2/431 (0.46%) |
4/427 (0.94%) |
| Fatigue † A # participants affected / at risk |
6/431 (1.39%) |
9/427 (2.11%) |
| Feeling hot † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Gravitational oedema † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Hypothermia † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Influenza like illness † A # participants affected / at risk |
1/431 (0.23%) |
4/427 (0.94%) |
| Malaise † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Oedema peripheral † A # participants affected / at risk |
4/431 (0.93%) |
12/427 (2.81%) |
| Pain † A # participants affected / at risk |
6/431 (1.39%) |
9/427 (2.11%) |
| Pyrexia † A # participants affected / at risk |
2/431 (0.46%) |
5/427 (1.17%) |
| Swelling † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Thirst † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Hepatobiliary disorders | ||
| Cholelithiasis † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Immune system disorders | ||
| Hypersensitivity † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Seasonal allergy † A # participants affected / at risk |
2/431 (0.46%) |
1/427 (0.23%) |
| Infections and infestations | ||
| Alveolar osteitis † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| American trypanosomiasis † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Amoebiasis † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Bronchitis † A # participants affected / at risk |
4/431 (0.93%) |
9/427 (2.11%) |
| Cellulitis † A # participants affected / at risk |
2/431 (0.46%) |
2/427 (0.47%) |
| Cystitis † A # participants affected / at risk |
1/431 (0.23%) |
4/427 (0.94%) |
| Diverticulitis † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Ear infection † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Fungal skin infection † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Gastroenteritis † A # participants affected / at risk |
2/431 (0.46%) |
0/427 (0.00%) |
| Gastroenteritis viral † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Groin abscess † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Herpes zoster † A # participants affected / at risk |
1/431 (0.23%) |
3/427 (0.70%) |
| Infected bites † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Influenza † A # participants affected / at risk |
10/431 (2.32%) |
9/427 (2.11%) |
| Labyrinthitis † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Laryngitis † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Localised infection † A # participants affected / at risk |
2/431 (0.46%) |
0/427 (0.00%) |
| Lower respiratory tract infection † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Lymph gland infection † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Nail infection † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Nasopharyngitis † A # participants affected / at risk |
19/431 (4.41%) |
20/427 (4.68%) |
| Onychomycosis † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Oral herpes † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Osteomyelitis † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Otitis externa † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Otitis media † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Otitis media acute † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Parasitic gastroenteritis † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Pharyngitis † A # participants affected / at risk |
4/431 (0.93%) |
3/427 (0.70%) |
| Pharyngitis streptococcal † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Pyelonephritis † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Pyoderma † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Rhinitis † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Sinusitis † A # participants affected / at risk |
11/431 (2.55%) |
10/427 (2.34%) |
| Sinusitis bacterial † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Tonsillitis † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Tooth abscess † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Tooth infection † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Upper respiratory tract infection † A # participants affected / at risk |
14/431 (3.25%) |
19/427 (4.45%) |
| Urinary tract infection † A # participants affected / at risk |
7/431 (1.62%) |
7/427 (1.64%) |
| Viral infection † A # participants affected / at risk |
3/431 (0.70%) |
4/427 (0.94%) |
| Viral pharyngitis † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Viral upper respiratory tract infection † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Vulvovaginal candidiasis † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Vulvovaginal mycotic infection † A # participants affected / at risk |
0/431 (0.00%) |
2/427 (0.47%) |
| Vulvovaginitis † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Wound infection † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Injury, poisoning and procedural complications | ||
| Animal bite † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Arthropod bite † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Arthropod sting † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Back injury † A # participants affected / at risk |
0/431 (0.00%) |
2/427 (0.47%) |
| Burns second degree † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Contusion † A # participants affected / at risk |
3/431 (0.70%) |
7/427 (1.64%) |
| Device breakage † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Epicondylitis † A # participants affected / at risk |
4/431 (0.93%) |
0/427 (0.00%) |
| Excoriation † A # participants affected / at risk |
0/431 (0.00%) |
2/427 (0.47%) |
| Eye injury † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Fall † A # participants affected / at risk |
1/431 (0.23%) |
2/427 (0.47%) |
| Joint injury † A # participants affected / at risk |
3/431 (0.70%) |
0/427 (0.00%) |
| Joint sprain † A # participants affected / at risk |
2/431 (0.46%) |
2/427 (0.47%) |
| Limb crushing injury † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Limb injury † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Meniscus lesion † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Muscle injury † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Muscle strain † A # participants affected / at risk |
1/431 (0.23%) |
2/427 (0.47%) |
| Neck injury † A # participants affected / at risk |
0/431 (0.00%) |
2/427 (0.47%) |
| Post-traumatic pain † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Procedural pain † A # participants affected / at risk |
2/431 (0.46%) |
0/427 (0.00%) |
| Repetitive strain injury † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Rib fracture † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Skeletal injury † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Skin laceration † A # participants affected / at risk |
2/431 (0.46%) |
0/427 (0.00%) |
| Snake bite † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Thermal burn † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Tooth fracture † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Wrist fracture † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Investigations | ||
| Alanine aminotransferase increased † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Aspartate aminotransferase increased † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Blood cholesterol increased † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Blood creatinine increased † A # participants affected / at risk |
0/431 (0.00%) |
2/427 (0.47%) |
| Blood potassium increased † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Blood pressure increased † A # participants affected / at risk |
0/431 (0.00%) |
4/427 (0.94%) |
| Blood urea increased † A # participants affected / at risk |
0/431 (0.00%) |
2/427 (0.47%) |
| Blood urine present † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Cardiac murmur † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Gamma-glutamyltransferase increased † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Heart rate irregular † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Hepatic enzyme increased † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Hepatitis C positive † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Weight increased † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Metabolism and nutrition disorders | ||
| Diabetes mellitus † A # participants affected / at risk |
1/431 (0.23%) |
2/427 (0.47%) |
| Fluid retention † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Hypercholesterolaemia † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Hyperglycaemia † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Hyperlipdaemia † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Hypertriglyceridaemia † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Increased appetite † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Polydipsia † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Vitamin D deficiency † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia † A # participants affected / at risk |
17/431 (3.94%) |
25/427 (5.85%) |
| Arthritis † A # participants affected / at risk |
0/431 (0.00%) |
2/427 (0.47%) |
| Back pain † A # participants affected / at risk |
20/431 (4.64%) |
31/427 (7.26%) |
| Bone pain † A # participants affected / at risk |
3/431 (0.70%) |
0/427 (0.00%) |
| Bursitis † A # participants affected / at risk |
6/431 (1.39%) |
2/427 (0.47%) |
| Cervical spinal stenosis † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Coccydynia † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Costochondritis † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Fibromyalgia † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Flank pain † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Groin pain † A # participants affected / at risk |
1/431 (0.23%) |
2/427 (0.47%) |
| Intervertebral disc degeneration † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Joint stiffness † A # participants affected / at risk |
1/431 (0.23%) |
2/427 (0.47%) |
| Joint swelling † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Muscle spasms † A # participants affected / at risk |
10/431 (2.32%) |
5/427 (1.17%) |
| Muscular weakness † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Musculoskeletal chest pain † A # participants affected / at risk |
0/431 (0.00%) |
2/427 (0.47%) |
| Musculoskeletal pain † A # participants affected / at risk |
7/431 (1.62%) |
12/427 (2.81%) |
| Musculoskeletal stiffness † A # participants affected / at risk |
0/431 (0.00%) |
2/427 (0.47%) |
| Myalgia † A # participants affected / at risk |
10/431 (2.32%) |
9/427 (2.11%) |
| Neck pain † A # participants affected / at risk |
7/431 (1.62%) |
7/427 (1.64%) |
| Osteoarthritis † A # participants affected / at risk |
7/431 (1.62%) |
2/427 (0.47%) |
| Osteopenia † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Pain in extremity † A # participants affected / at risk |
18/431 (4.18%) |
21/427 (4.92%) |
| Pain in jaw † A # participants affected / at risk |
0/431 (0.00%) |
2/427 (0.47%) |
| Periarthritis † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Plantar fasciitis † A # participants affected / at risk |
0/431 (0.00%) |
3/427 (0.70%) |
| Rotator cuff syndrome † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Sacroiliitis † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Sensation of heaviness † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Spondyloarthropathy † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Synovial cyst † A # participants affected / at risk |
0/431 (0.00%) |
2/427 (0.47%) |
| Synovitis † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Temporomandibular joint syndrome † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Tendon pain † A # participants affected / at risk |
0/431 (0.00%) |
2/427 (0.47%) |
| Tendonitis † A # participants affected / at risk |
0/431 (0.00%) |
2/427 (0.47%) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Basal cell carcinoma † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Melanocytic naevus † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Neoplasm † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Seborrhoeic keratosis † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Skin papilloma † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Thyroid neoplasm † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Nervous system disorders | ||
| Carpal tunnel syndrome † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Cluster headache † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Dizziness † A # participants affected / at risk |
8/431 (1.86%) |
8/427 (1.87%) |
| Dysgeusia † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Facial palsy † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Headache † A # participants affected / at risk |
65/431 (15.08%) |
68/427 (15.93%) |
| Hypoaesthesia † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Lethargy † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Lumbar radiculopathy † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Migraine † A # participants affected / at risk |
1/431 (0.23%) |
2/427 (0.47%) |
| Migraine with aura † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Neuropathy peripheral † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Paraesthesia † A # participants affected / at risk |
2/431 (0.46%) |
3/427 (0.70%) |
| Poor quality sleep † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Restless legs syndrome † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Sciatica † A # participants affected / at risk |
1/431 (0.23%) |
2/427 (0.47%) |
| Sinus headache † A # participants affected / at risk |
2/431 (0.46%) |
1/427 (0.23%) |
| Somnolence † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Syncope † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Tension headache † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Tremor † A # participants affected / at risk |
2/431 (0.46%) |
1/427 (0.23%) |
| Psychiatric disorders | ||
| Adjustment disorder † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Anxiety † A # participants affected / at risk |
4/431 (0.93%) |
1/427 (0.23%) |
| Attention deficit / hyperactivity disorder † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Confusional state † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Depressed mood † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Depression † A # participants affected / at risk |
5/431 (1.16%) |
3/427 (0.70%) |
| Disorientation † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Insomnia † A # participants affected / at risk |
11/431 (2.55%) |
8/427 (1.87%) |
| Libido decreased † A # participants affected / at risk |
2/431 (0.46%) |
0/427 (0.00%) |
| Nervousness † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Nightmare † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Restlessness † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Sleep disorder † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Stress † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Renal and urinary disorders | ||
| Dysuria † A # participants affected / at risk |
2/431 (0.46%) |
0/427 (0.00%) |
| Haematuria † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Hypertonic bladder † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Micturition frequency decreased † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Nephrolithiasis † A # participants affected / at risk |
0/431 (0.00%) |
2/427 (0.47%) |
| Oliguria † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Pollakiuria † A # participants affected / at risk |
0/431 (0.00%) |
2/427 (0.47%) |
| Renal colic † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Renal pain † A # participants affected / at risk |
2/431 (0.46%) |
0/427 (0.00%) |
| Urine odour abnormal † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Reproductive system and breast disorders | ||
| Adnexa uteri pain † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Breast mass † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Breast pain † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Dysmenorrhoea † A # participants affected / at risk |
2/431 (0.46%) |
4/427 (0.94%) |
| Erectile dysfunction † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Menorrhagia † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Menstrual disorder † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Uterine polyp † A # participants affected / at risk |
0/431 (0.00%) |
2/427 (0.47%) |
| Vulvovaginal dryness † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Respiratory, thoracic and mediastinal disorders | ||
| Asthma † A # participants affected / at risk |
4/431 (0.93%) |
2/427 (0.47%) |
| Bronchial obstruction † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Chronic obstructive pulmonary disease † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Cough † A # participants affected / at risk |
4/431 (0.93%) |
4/427 (0.94%) |
| Dyspnoea † A # participants affected / at risk |
3/431 (0.70%) |
3/427 (0.70%) |
| Epistaxis † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Increased upper airway secretion † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Nasal congestion † A # participants affected / at risk |
5/431 (1.16%) |
3/427 (0.70%) |
| Nasal dryness † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Oropharyngeal pain † A # participants affected / at risk |
7/431 (1.62%) |
4/427 (0.94%) |
| Paranasal sinus hypersecretion † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Pharyngeal oedema † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Pleuritic pain † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Pulmonary congestion † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Rales † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Rhinitis allergic † A # participants affected / at risk |
3/431 (0.70%) |
2/427 (0.47%) |
| Rhinorrhoea † A # participants affected / at risk |
2/431 (0.46%) |
0/427 (0.00%) |
| Sinus congestion † A # participants affected / at risk |
3/431 (0.70%) |
2/427 (0.47%) |
| Wheezing † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Skin and subcutaneous tissue disorders | ||
| Alopecia † A # participants affected / at risk |
2/431 (0.46%) |
0/427 (0.00%) |
| Blister † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Dermatitis † A # participants affected / at risk |
0/431 (0.00%) |
3/427 (0.70%) |
| Dermatitis allergic † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Dermatitis contact † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Eczema † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Eczema asteatotic † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Erythema † A # participants affected / at risk |
2/431 (0.46%) |
0/427 (0.00%) |
| Hair texture abnormal † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Hyperkeratosis † A # participants affected / at risk |
0/431 (0.00%) |
2/427 (0.47%) |
| Increased tendency to bruise † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Ingrown hair † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Pruritus † A # participants affected / at risk |
3/431 (0.70%) |
2/427 (0.47%) |
| Rash † A # participants affected / at risk |
1/431 (0.23%) |
7/427 (1.64%) |
| Rash erythematous † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Rash papular † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Rash pruritic † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Scar † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Seborrhoea † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Skin discolouration † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Urticaria † A # participants affected / at risk |
1/431 (0.23%) |
1/427 (0.23%) |
| Surgical and medical procedures | ||
| Myringoplasty † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Nail operation † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Tooth extraction † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Vasectomy † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Vascular disorders | ||
| Flushing † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| Hot flush † A # participants affected / at risk |
2/431 (0.46%) |
0/427 (0.00%) |
| Hypertension † A # participants affected / at risk |
9/431 (2.09%) |
13/427 (3.04%) |
| Systolic hypertension † A # participants affected / at risk |
1/431 (0.23%) |
0/427 (0.00%) |
| Varicose vein † A # participants affected / at risk |
0/431 (0.00%) |
1/427 (0.23%) |
| † | Indicates events were collected by systematic assessment. |
|---|---|
| A | Term from vocabulary, MedDRA (v11.1) |
More Information
| 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. | ||||||
The agreement is:
|
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | Pfizer ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A3191173 |
| Study First Received: | August 29, 2005 |
| Results First Received: | February 20, 2009 |
| Last Updated: | June 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00139776 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
