SINCERE: Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00688545
Collaborator
(none)
275
27
33
10.2
0.3
Study Details
Study Description
Brief Summary
This multi-center observational Registry will collect long-term safety data on patients treated with celecoxib or non-selective nonsteroidal anti-inflammatory drugs (nsNSAIDs) as used in clinical practice for the treatment of Juvenile Idiopathic Arthritis (JIA).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
None Study has been terminated early (LSLV = 09Jan2012) due to release of the postmarketing commitment by the US FDA. The study was stopped for futility/change in treatment paradigm that minimizes chronic NSAID use and not for safety concerns.
Study Design
Study Type:
Observational
Actual Enrollment
:
275 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
SINCERE™: Safety in Idiopathic Arthritis: NSAIDs and Celebrex Evaluation Registry A Prospective Observational Registry Of Patients With Juvenile Idiopathic Arthritis (JIA) Treated With NSAIDs
Study Start Date
:
Apr 1, 2009
Actual Primary Completion Date
:
Jan 1, 2012
Actual Study Completion Date
:
Jan 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Celecoxib Patients treated with celecoxib as per treating physician's judgement |
Drug: Celecoxib
Non-interventional: Treatment assignment as per treating physician's judgement
|
| nsNSAIDs (nonselective nonsteroidal anti-inflammatory drugs) Patients treated with nsNSAIDs as per treating physician's judgement |
Drug: nsNSAIDs
Non-interventional: Treatment assignment as per treating physician's judgement
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to 2 years]
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.
- JIA Concomitant Medications [Year 2 or early termination]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age at least 2 years but less than 18 years; JIA of any of the following subtypes: oligoarthritis, polyarthritis, or stable systemic disease;
-
new treatment (started not more than 6 months prior) with one NSAID (celecoxib or nsNSAID).
Exclusion Criteria:
-
Patients with the following JIA subtypes: active systemic disease, psoriatic Arthritis, enthesitis-related Arthritis, or undifferentiated arthritis;
-
Patients with Reiter's syndrome; patients unlikely to complete 2 years of follow up;
-
Patients who need to use multiple NSAIDs at the same time.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85006 |
| 2 | Pfizer Investigational Site | Little Rock | Arkansas | United States | 72202 |
| 3 | Pfizer Investigational Site | Washington | District of Columbia | United States | 20010 |
| 4 | Pfizer Investigational Site | Arlington Heights | Illinois | United States | 60005 |
| 5 | Pfizer Investigational Site | Chicago | Illinois | United States | 60637 |
| 6 | Pfizer Investigational Site | Glenview | Illinois | United States | 60025 |
| 7 | Pfizer Investigational Site | New Lenox | Illinois | United States | 60451 |
| 8 | Pfizer Investigational Site | Westchester | Illinois | United States | 60154 |
| 9 | Pfizer Investigational Site | Omaha | Nebraska | United States | 68114 |
| 10 | Pfizer Investigational Site | Hackensack | New Jersey | United States | 07601 |
| 11 | Pfizer Investigational Site | Livingston | New Jersey | United States | 07039 |
| 12 | Pfizer Investigational Site | Brooklyn | New York | United States | 11211 |
| 13 | Pfizer Investigational Site | Brooklyn | New York | United States | 11214 |
| 14 | Pfizer Investigational Site | Commack | New York | United States | 11725 |
| 15 | Pfizer Investigational Site | Great Neck | New York | United States | 11021 |
| 16 | Pfizer Investigational Site | New Hyde Park | New York | United States | 11040 |
| 17 | Pfizer Investigational Site | New York | New York | United States | 10016 |
| 18 | Pfizer Investigational Site | Durham | North Carolina | United States | 27710 |
| 19 | Pfizer Investigational Site | Cincinnati | Ohio | United States | 45229-3026 |
| 20 | Pfizer Investigational Site | Cleveland | Ohio | United States | 44106 |
| 21 | Pfizer Investigational Site | Liberty Township | Ohio | United States | 45044 |
| 22 | Pfizer Investigational Site | Mayfield Heights | Ohio | United States | 44124 |
| 23 | Pfizer Investigational Site | Strongsville | Ohio | United States | 44136 |
| 24 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19134-1095 |
| 25 | Pfizer Investigational Site | Charleston | South Carolina | United States | 29425 |
| 26 | Pfizer Investigational Site | Nashville | Tennessee | United States | 37232-9263 |
| 27 | Pfizer Investigational Site | Austin | Texas | United States | 78723 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00688545
Other Study ID Numbers:
- A3191344
First Posted:
Jun 3, 2008
Last Update Posted:
Feb 2, 2021
Last Verified:
Jan 1, 2021
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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 |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Celecoxib | nsNSAIDs | Total |
|---|---|---|---|
| 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 Participants | 55 | 219 | 274 |
| Age, Customized (Number) [Number] | |||
| 2-5 years |
8
14.5%
|
77
35.2%
|
85
31%
|
| 6-9 years |
17
30.9%
|
52
23.7%
|
69
25.2%
|
| 10-12 years |
15
27.3%
|
44
20.1%
|
59
21.5%
|
| 13-15 years |
7
12.7%
|
35
16%
|
42
15.3%
|
| 16-18 years |
8
14.5%
|
11
5%
|
19
6.9%
|
| Sex: Female, Male (Count of 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) (Number) [Number] | |||
| Systemic |
0
0%
|
3
1.4%
|
3
1.1%
|
| Persistent Oligoarticular |
27
49.1%
|
119
54.3%
|
146
53.3%
|
| Extended Oligoarticular |
2
3.6%
|
12
5.5%
|
14
5.1%
|
| Poly RF- |
23
41.8%
|
70
32%
|
93
33.9%
|
| Poly RF+ |
3
5.5%
|
14
6.4%
|
17
6.2%
|
| Missing |
0
0%
|
1
0.5%
|
1
0.4%
|
| Gastrointestinal Symptom Scale for Kids (GISSK) - Type of stomach problems (Number) [Number] | |||
| Heartburn |
9
16.4%
|
21
9.6%
|
30
10.9%
|
| Upper stomach pain |
8
14.5%
|
18
8.2%
|
26
9.5%
|
| Lower stomach pain |
16
29.1%
|
34
15.5%
|
50
18.2%
|
| Nausea |
14
25.5%
|
32
14.6%
|
46
16.8%
|
| Diarrhea |
5
9.1%
|
18
8.2%
|
23
8.4%
|
| Constipation |
5
9.1%
|
16
7.3%
|
21
7.7%
|
| Vomiting |
2
3.6%
|
8
3.7%
|
10
3.6%
|
| Poor appetite |
7
12.7%
|
13
5.9%
|
20
7.3%
|
| No problems |
23
41.8%
|
132
60.3%
|
155
56.6%
|
| Missing |
1
1.8%
|
3
1.4%
|
4
1.5%
|
| JIA medications (Number) [Number] | |||
| Gastrointestinal (GI) protective agents |
18
32.7%
|
48
21.9%
|
66
24.1%
|
| Other GI |
4
7.3%
|
4
1.8%
|
8
2.9%
|
| Disease-modifying antirheumatic drugs (DMARDs) |
21
38.2%
|
83
37.9%
|
104
38%
|
| Biologics |
8
14.5%
|
28
12.8%
|
36
13.1%
|
| Antihypertensives |
1
1.8%
|
4
1.8%
|
5
1.8%
|
| NSAIDs (Celecoxib) |
8
14.5%
|
0
0%
|
8
2.9%
|
| NSAIDs (Diclofenac) |
0
0%
|
0
0%
|
0
0%
|
| NSAIDs (Ibuprofen) |
2
3.6%
|
7
3.2%
|
9
3.3%
|
| NSAIDs (Meloxicam) |
0
0%
|
6
2.7%
|
6
2.2%
|
| NSAIDs (Naproxen) |
0
0%
|
16
7.3%
|
16
5.8%
|
| NSAIDs (Other) |
0
0%
|
5
2.3%
|
5
1.8%
|
| Corticosteroids (Oral, IV, Intra-Articular) |
5
9.1%
|
19
8.7%
|
24
8.8%
|
| Corticosteroids (Other) |
2
3.6%
|
3
1.4%
|
5
1.8%
|
| Analgesics (Acetaminophen, Opioids, Other) |
9
16.4%
|
18
8.2%
|
27
9.9%
|
| Number of participants with abnormal physical exam results (Number) [Number] | |||
| Number [Participants] |
17
30.9%
|
63
28.8%
|
80
29.2%
|
| Physician Global Assessment (PGA) of Disease Activity (Units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Units on a scale] |
2.6
(2.36)
|
2.9
(2.19)
|
2.8
(2.22)
|
| Participant or caregiver's assessment of participant's overall well-being (Units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Units on a scale] |
3.2
(2.58)
|
2.8
(2.50)
|
2.9
(2.52)
|
| Child Health Questionnaire (CHAQ) - global evaluation (Units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Units on a scale] |
29.11
(29.34)
|
20.15
(21.58)
|
21.96
(23.56)
|
| CHAQ - pain (Units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Units on a scale] |
0.92
(0.85)
|
0.71
(0.72)
|
0.75
(0.75)
|
| CHAQ - functioning (Units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Units on a scale] |
0.65
(0.68)
|
0.48
(0.54)
|
0.52
(0.57)
|
| Number of joints with active arthritis (Joints) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Joints] |
3.4
(5.39)
|
2.9
(4.14)
|
3.0
(4.42)
|
| GISSK - severity of stomach problems (Units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Units on a scale] |
21.9
(25.75)
|
12.0
(19.84)
|
14.0
(21.47)
|
| Body weight (kilogram (kg)) [Median (Full Range) ] | |||
| Median (Full Range) [kilogram (kg)] |
33.60
|
30.20
|
30.90
|
| Height (centimeters (cm)) [Median (Full Range) ] | |||
| Median (Full Range) [centimeters (cm)] |
141.30
|
130.10
|
132.00
|
| Body Mass Index (BMI) (kilograms per meter squared (kg/m^2)) [Median (Full Range) ] | |||
| Median (Full Range) [kilograms per meter squared (kg/m^2)] |
17.70
|
17.31
|
17.55
|
| Weight and Height percentiles overall (Percentile) [Mean (Standard Deviation) ] | |||
| 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)
|
Outcome Measures
| Title | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 68 | 225 |
| AEs |
36
65.5%
|
117
53.4%
|
| SAEs |
2
3.6%
|
9
4.1%
|
| Title | JIA Concomitant Medications |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set subset of participants who received JIA concomitant medications |
| Arm/Group Title | Celecoxib | nsNSAIDs |
|---|---|---|
| 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. |
| Measure Participants | 39 | 148 |
| GI protective agents |
20
36.4%
|
54
24.7%
|
| Other GI |
5
9.1%
|
8
3.7%
|
| DMARDs |
24
43.6%
|
102
46.6%
|
| Biologics |
13
23.6%
|
60
27.4%
|
| Antihypertensives |
1
1.8%
|
4
1.8%
|
| NSAIDs (Celecoxib) |
7
12.7%
|
2
0.9%
|
| NSAIDs (Diclofenac) |
0
0%
|
0
0%
|
| NSAIDs (Ibuprofen) |
1
1.8%
|
9
4.1%
|
| NSAIDs (Meloxicam) |
1
1.8%
|
8
3.7%
|
| NSAIDs (Naproxen) |
0
0%
|
7
3.2%
|
| NSAIDs (Other) |
0
0%
|
3
1.4%
|
| Corticosteroids (oral, IV, intra-articular) |
4
7.3%
|
15
6.8%
|
| Corticosteroids (Other) |
2
3.6%
|
6
2.7%
|
| Analgesics (Acetaminophen, Opioids, Other) |
11
20%
|
19
8.7%
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| 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 | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Celecoxib | nsNSAIDs | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/68 (2.9%) | 9/225 (4%) | ||
| Blood and lymphatic system disorders | ||||
| Febrile Neutropenia | 0/68 (0%) | 1/225 (0.4%) | ||
| Agranulocytosis | 0/68 (0%) | 1/225 (0.4%) | ||
| Gastrointestinal disorders | ||||
| Abdominal Pain Lower | 0/68 (0%) | 1/225 (0.4%) | ||
| General disorders | ||||
| Condition Aggravated | 1/68 (1.5%) | 0/225 (0%) | ||
| Pyrexia | 1/68 (1.5%) | 0/225 (0%) | ||
| Infections and infestations | ||||
| Cellulitis | 1/68 (1.5%) | 1/225 (0.4%) | ||
| Appendicitis | 0/68 (0%) | 1/225 (0.4%) | ||
| Arthritis Bacterial | 0/68 (0%) | 1/225 (0.4%) | ||
| Meningitis | 0/68 (0%) | 1/225 (0.4%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Juvenile Arthritis | 0/68 (0%) | 1/225 (0.4%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Fibrous Histiocytoma | 0/68 (0%) | 1/225 (0.4%) | ||
| Nervous system disorders | ||||
| Migraine | 1/68 (1.5%) | 0/225 (0%) | ||
| Pregnancy, puerperium and perinatal conditions | ||||
| Unintended Pregnancy | 0/68 (0%) | 1/225 (0.4%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Celecoxib | nsNSAIDs | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 35/68 (51.5%) | 114/225 (50.7%) | ||
| Blood and lymphatic system disorders | ||||
| Lymphadenopathy | 1/68 (1.5%) | 1/225 (0.4%) | ||
| Anaemia | 0/68 (0%) | 1/225 (0.4%) | ||
| Leukopenia | 0/68 (0%) | 1/225 (0.4%) | ||
| Lymphopenia | 0/68 (0%) | 1/225 (0.4%) | ||
| Cardiac disorders | ||||
| Tachycardia | 1/68 (1.5%) | 0/225 (0%) | ||
| Congenital, familial and genetic disorders | ||||
| Micrognathia | 1/68 (1.5%) | 0/225 (0%) | ||
| Eye disorders | ||||
| Uveitis | 0/68 (0%) | 6/225 (2.7%) | ||
| Chalazion | 0/68 (0%) | 1/225 (0.4%) | ||
| Conjunctivitis | 0/68 (0%) | 1/225 (0.4%) | ||
| Dry eye | 0/68 (0%) | 1/225 (0.4%) | ||
| Eye Pain | 0/68 (0%) | 1/225 (0.4%) | ||
| Hypermetropia | 0/68 (0%) | 1/225 (0.4%) | ||
| Vision Blurred | 0/68 (0%) | 1/225 (0.4%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 11/68 (16.2%) | 28/225 (12.4%) | ||
| Abdominal pain | 9/68 (13.2%) | 27/225 (12%) | ||
| Diarrhoea | 2/68 (2.9%) | 16/225 (7.1%) | ||
| Vomiting | 5/68 (7.4%) | 8/225 (3.6%) | ||
| Abdominal Pain Upper | 3/68 (4.4%) | 9/225 (4%) | ||
| Constipation | 2/68 (2.9%) | 9/225 (4%) | ||
| Dyspepsia | 3/68 (4.4%) | 8/225 (3.6%) | ||
| Abdominal Pain Lower | 1/68 (1.5%) | 6/225 (2.7%) | ||
| Gastrooesophageal Reflux Disease | 0/68 (0%) | 6/225 (2.7%) | ||
| Stomatitis | 2/68 (2.9%) | 4/225 (1.8%) | ||
| Mouth Ulceration | 1/68 (1.5%) | 2/225 (0.9%) | ||
| Abdominal Distension | 1/68 (1.5%) | 1/225 (0.4%) | ||
| Dry Mouth | 0/68 (0%) | 2/225 (0.9%) | ||
| Faeces Discoloured | 1/68 (1.5%) | 1/225 (0.4%) | ||
| Faeces Hard | 0/68 (0%) | 2/225 (0.9%) | ||
| Coeliac Disease | 1/68 (1.5%) | 0/225 (0%) | ||
| Crohn's Disease | 0/68 (0%) | 1/225 (0.4%) | ||
| Gastritis | 0/68 (0%) | 1/225 (0.4%) | ||
| Inguinal Hernia | 0/68 (0%) | 1/225 (0.4%) | ||
| Oesophagitis | 1/68 (1.5%) | 0/225 (0%) | ||
| General disorders | ||||
| Disease Progression | 2/68 (2.9%) | 5/225 (2.2%) | ||
| Pyrexia | 0/68 (0%) | 4/225 (1.8%) | ||
| Chest Pain | 2/68 (2.9%) | 0/225 (0%) | ||
| Drug Intolerance | 0/68 (0%) | 2/225 (0.9%) | ||
| Fatigue | 0/68 (0%) | 2/225 (0.9%) | ||
| Irritability | 0/68 (0%) | 1/225 (0.4%) | ||
| Mucosal Inflammation | 0/68 (0%) | 1/225 (0.4%) | ||
| Immune system disorders | ||||
| Drug Hypersensitivity | 0/68 (0%) | 1/225 (0.4%) | ||
| Hypersensitivity | 0/68 (0%) | 1/225 (0.4%) | ||
| Latex Allergy | 0/68 (0%) | 1/225 (0.4%) | ||
| Seasonal Allergy | 0/68 (0%) | 1/225 (0.4%) | ||
| Infections and infestations | ||||
| Upper Respiratory Tract Infection | 1/68 (1.5%) | 7/225 (3.1%) | ||
| Pharyngitis Streptococcal | 1/68 (1.5%) | 5/225 (2.2%) | ||
| Pneumonia | 2/68 (2.9%) | 2/225 (0.9%) | ||
| Sinusitis | 1/68 (1.5%) | 3/225 (1.3%) | ||
| Ear Infection | 1/68 (1.5%) | 2/225 (0.9%) | ||
| Influenza | 2/68 (2.9%) | 1/225 (0.4%) | ||
| Otitis Media | 1/68 (1.5%) | 2/225 (0.9%) | ||
| Pharyngitis | 2/68 (2.9%) | 1/225 (0.4%) | ||
| Viral Infection | 1/68 (1.5%) | 2/225 (0.9%) | ||
| Fungal Skin Infection | 1/68 (1.5%) | 1/225 (0.4%) | ||
| Gastroenteritis | 0/68 (0%) | 2/225 (0.9%) | ||
| Tonsillitis | 0/68 (0%) | 2/225 (0.9%) | ||
| Adenoiditis | 0/68 (0%) | 1/225 (0.4%) | ||
| Bronchitis | 0/68 (0%) | 1/225 (0.4%) | ||
| Cellulitis | 0/68 (0%) | 1/225 (0.4%) | ||
| Chronic Tonsillitis | 1/68 (1.5%) | 0/225 (0%) | ||
| Conjunctivitis Infective | 0/68 (0%) | 1/225 (0.4%) | ||
| Coxsackie Viral Infection | 0/68 (0%) | 1/225 (0.4%) | ||
| Cystitis | 0/68 (0%) | 1/225 (0.4%) | ||
| Erythema Infectiosum | 0/68 (0%) | 1/225 (0.4%) | ||
| Eye Infection Bacterial | 0/68 (0%) | 1/225 (0.4%) | ||
| Eye Infection Viral | 0/68 (0%) | 1/225 (0.4%) | ||
| Fungal Infection | 0/68 (0%) | 1/225 (0.4%) | ||
| Furuncle | 0/68 (0%) | 1/225 (0.4%) | ||
| Gastroenteritis Viral | 0/68 (0%) | 1/225 (0.4%) | ||
| Impetigo | 0/68 (0%) | 1/225 (0.4%) | ||
| Infection | 1/68 (1.5%) | 0/225 (0%) | ||
| Molluscum Contagiosum | 0/68 (0%) | 1/225 (0.4%) | ||
| Onychomycosis | 0/68 (0%) | 1/225 (0.4%) | ||
| Otitis Externa | 0/68 (0%) | 1/225 (0.4%) | ||
| Paronychia | 0/68 (0%) | 1/225 (0.4%) | ||
| Rash Pustular | 0/68 (0%) | 1/225 (0.4%) | ||
| Staphylococcal Infection | 0/68 (0%) | 1/225 (0.4%) | ||
| Streptococcal Infection | 0/68 (0%) | 1/225 (0.4%) | ||
| Subcutaneous Abscess | 0/68 (0%) | 1/225 (0.4%) | ||
| Tonsillitis Streptococcal | 0/68 (0%) | 1/225 (0.4%) | ||
| Urinary Tract Infection | 0/68 (0%) | 1/225 (0.4%) | ||
| Injury, poisoning and procedural complications | ||||
| Contusion | 0/68 (0%) | 6/225 (2.7%) | ||
| Arthropod Bite | 0/68 (0%) | 2/225 (0.9%) | ||
| Lower Limb Fracture | 0/68 (0%) | 1/225 (0.4%) | ||
| Investigations | ||||
| Weight Decreased | 1/68 (1.5%) | 1/225 (0.4%) | ||
| Blood Pressure Increased | 0/68 (0%) | 1/225 (0.4%) | ||
| Blood Urea Increased | 0/68 (0%) | 1/225 (0.4%) | ||
| C-reactive Protein Increased | 0/68 (0%) | 1/225 (0.4%) | ||
| Hepatic Enzyme Increased | 0/68 (0%) | 1/225 (0.4%) | ||
| Red Blood Cell Sedimentation Rate Increased | 0/68 (0%) | 1/225 (0.4%) | ||
| Weight Increased | 0/68 (0%) | 1/225 (0.4%) | ||
| Metabolism and nutrition disorders | ||||
| Anorexia | 3/68 (4.4%) | 10/225 (4.4%) | ||
| Decreased Appetite | 0/68 (0%) | 1/225 (0.4%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthritis | 0/68 (0%) | 3/225 (1.3%) | ||
| Back Pain | 0/68 (0%) | 3/225 (1.3%) | ||
| Arthralgia | 0/68 (0%) | 1/225 (0.4%) | ||
| Growth Retardation | 0/68 (0%) | 1/225 (0.4%) | ||
| Joint Effusion | 0/68 (0%) | 1/225 (0.4%) | ||
| Muscle Atrophy | 0/68 (0%) | 1/225 (0.4%) | ||
| Muscle Spasms | 0/68 (0%) | 1/225 (0.4%) | ||
| Osteoporosis | 0/68 (0%) | 1/225 (0.4%) | ||
| Synovial Cyst | 0/68 (0%) | 1/225 (0.4%) | ||
| Unequal Limb Length | 1/68 (1.5%) | 0/225 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Lipoma | 1/68 (1.5%) | 0/225 (0%) | ||
| Nervous system disorders | ||||
| Headache | 3/68 (4.4%) | 9/225 (4%) | ||
| Dizziness | 0/68 (0%) | 3/225 (1.3%) | ||
| Convulsion | 0/68 (0%) | 2/225 (0.9%) | ||
| Cognitive Disorder | 0/68 (0%) | 1/225 (0.4%) | ||
| Disturbance In Attention | 0/68 (0%) | 1/225 (0.4%) | ||
| Dysgeusia | 0/68 (0%) | 1/225 (0.4%) | ||
| Dyskinesia | 1/68 (1.5%) | 0/225 (0%) | ||
| Memory Impairment | 0/68 (0%) | 1/225 (0.4%) | ||
| Migraine | 0/68 (0%) | 1/225 (0.4%) | ||
| Paraesthesia | 0/68 (0%) | 1/225 (0.4%) | ||
| Psychomotor Hyperactivity | 0/68 (0%) | 1/225 (0.4%) | ||
| Tremor | 0/68 (0%) | 1/225 (0.4%) | ||
| Psychiatric disorders | ||||
| Attention Deficit/Hyperactivity Disorder | 0/68 (0%) | 1/225 (0.4%) | ||
| Confusional State | 0/68 (0%) | 1/225 (0.4%) | ||
| Initial Insomnia | 1/68 (1.5%) | 0/225 (0%) | ||
| Insomnia | 0/68 (0%) | 1/225 (0.4%) | ||
| Mood Altered | 0/68 (0%) | 1/225 (0.4%) | ||
| Sleep Disorder | 0/68 (0%) | 1/225 (0.4%) | ||
| Renal and urinary disorders | ||||
| Haematuria | 0/68 (0%) | 3/225 (1.3%) | ||
| Urinary Incontinence | 1/68 (1.5%) | 1/225 (0.4%) | ||
| Dysuria | 1/68 (1.5%) | 0/225 (0%) | ||
| Proteinuria | 1/68 (1.5%) | 0/225 (0%) | ||
| Reproductive system and breast disorders | ||||
| Menstruation Irregular | 0/68 (0%) | 1/225 (0.4%) | ||
| Vaginal Discharge | 1/68 (1.5%) | 0/225 (0%) | ||
| Vulval Disorder | 1/68 (1.5%) | 0/225 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma Exercise Induced | 0/68 (0%) | 1/225 (0.4%) | ||
| Cough | 0/68 (0%) | 1/225 (0.4%) | ||
| Dyspnoea | 0/68 (0%) | 1/225 (0.4%) | ||
| Dyspnoea Exertional | 0/68 (0%) | 1/225 (0.4%) | ||
| Oropharyngeal Pain | 0/68 (0%) | 1/225 (0.4%) | ||
| Pleuritic Pain | 0/68 (0%) | 1/225 (0.4%) | ||
| Postnasal Drip | 0/68 (0%) | 1/225 (0.4%) | ||
| Rhinitis Allergic | 0/68 (0%) | 1/225 (0.4%) | ||
| Tonsillar Hypertrophy | 0/68 (0%) | 1/225 (0.4%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 1/68 (1.5%) | 4/225 (1.8%) | ||
| Rash | 3/68 (4.4%) | 2/225 (0.9%) | ||
| Eczema | 0/68 (0%) | 3/225 (1.3%) | ||
| Pseudoporphyria | 0/68 (0%) | 3/225 (1.3%) | ||
| Urticaria | 0/68 (0%) | 2/225 (0.9%) | ||
| Dry Skin | 0/68 (0%) | 1/225 (0.4%) | ||
| Ecchymosis | 0/68 (0%) | 1/225 (0.4%) | ||
| Erythema Multiforme | 0/68 (0%) | 1/225 (0.4%) | ||
| Keratosis Pilaris | 0/68 (0%) | 1/225 (0.4%) | ||
| Pruritus | 1/68 (1.5%) | 0/225 (0%) | ||
| Rash Erythematous | 0/68 (0%) | 1/225 (0.4%) | ||
| Rash Papular | 1/68 (1.5%) | 0/225 (0%) | ||
| Rash Pruritic | 0/68 (0%) | 1/225 (0.4%) | ||
| Seborrhoea | 0/68 (0%) | 1/225 (0.4%) | ||
| Skin Exfoliation | 0/68 (0%) | 1/225 (0.4%) | ||
| Swelling Face | 0/68 (0%) | 1/225 (0.4%) | ||
| Vitiligo | 0/68 (0%) | 1/225 (0.4%) | ||
| Surgical and medical procedures | ||||
| Joint Arthroplasty | 1/68 (1.5%) | 0/225 (0%) | ||
| Vascular disorders | ||||
| Flushing | 0/68 (0%) | 1/225 (0.4%) | ||
Limitations/Caveats
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.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00688545
Other Study ID Numbers:
- A3191344
First Posted:
Jun 3, 2008
Last Update Posted:
Feb 2, 2021
Last Verified:
Jan 1, 2021