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See termination reason in detailed description.
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The Purpose of this trial is to evaluate the use of a cross-over trial design in an osteoarthritis population. We will determine the inter- and intra-subject variability in osteoarthritis (OA) endpoints and evaluate if efficacy can be detected by measuring OA endpoints following treatment with 2 different types of analgesics in a crossover study of this design.
Methodology study to evaluate the use of a cross over design and gait analysis. The study was terminated by mutual consent with the study site at a meeting on the 1 April 2009, because of slow recruitment due to a high screen fail rate. The study was not stopped for safety reasons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Active Comparator |
| |
| C | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| celecoxib | Drug | oral, 100 mg bid |
| |
| Oxycodone |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Knee Pain Intensity Measured by Numeric Rating Scale (NRS) at Week 12 | The severity of arthritis pain in participant's signal knee at the time of the visit was assessed using an 11-point NRS, ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. | Baseline, Week 12 |
| Change From Baseline in Knee Pain Intensity Measured by Visual Analog Scale (VAS) at Week 12 | The severity of arthritis pain in participant's signal knee was assessed using a 100-millimeter (mm) VAS ranging from 0 mm = no pain and 100 mm = most severe pain. Higher score indicate more pain. | Baseline, Week 12 |
| Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Pain Subscale Score at Week 12 | WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). The index consists of 24 questions (5 pain, 2 stiffness, and 17 physical function). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of to be replaced/replaced index joint (knee or hip) during past 48 hours. The WOMAC pain subscale score for each question ranges from 0 (minimum) to 4 (maximum), higher scores signifies worse pain. Pain subscale total score ranges from 0 to 20, with higher scores indicating worse pain. | Baseline, Week 12 |
| Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Physical Function Subscale Score at Week 12 | WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in in the study joint during past 48 hours. The WOMAC physical function subscale score for each question ranges from 0 (minimum) to 4 (maximum), higher scores signifies worse physical function. Physical function subscale scores range from 0 to 68, where higher scores indicated more difficulty in performing daily activities. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VAPAHCS | Palo Alto | California | 94304-1290 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23508626 | Derived | Asay JL, Boyer KA, Andriacchi TP. Repeatability of gait analysis for measuring knee osteoarthritis pain in patients with severe chronic pain. J Orthop Res. 2013 Jul;31(7):1007-12. doi: 10.1002/jor.22228. Epub 2013 Mar 18. | |
| 22179861 | Derived | Boyer KA, Angst MS, Asay J, Giori NJ, Andriacchi TP. Sensitivity of gait parameters to the effects of anti-inflammatory and opioid treatments in knee osteoarthritis patients. J Orthop Res. 2012 Jul;30(7):1118-24. doi: 10.1002/jor.22037. Epub 2011 Dec 16. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Total 6 participants were randomized to receive 1 of 6 possible treatment sequences of ABC, ACB. BAC, BCA, CAB, CBA (where: A=placebo, B=celecoxib, C=oxycodone) in treatment periods 1, 2 and 3 (each 2-week treatment period was separated by a 2-week washout period).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then Celecoxib Then Oxycodone | Participants received placebo capsules matched to celecoxib and oxycodone orally, twice daily from Days 1 to 14 of treatment period 1 (participants received placebo from Days 1 to 84 in 3 treatment periods [14 days prior to each treatment periods {i.e. during 2-week washout period}, and Day 1-14 in each treatment period]), then in treatment period 2 participants received celecoxib 100 milligram (mg) (200 milligram per day [mg/day]) capsule orally, twice daily on Days 1-14 followed by oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14 in treatment period 3. Each 2-week treatment period was separated by a 2-week washout period. |
| FG001 | Placebo Then Oxycodone Then Celecoxib | Participants received placebo capsules matched to celecoxib and oxycodone orally, twice daily from Days 1 to 14 of treatment period 1 (participants received placebo from Days 1 to 84 in 3 treatment periods [14 days prior to each treatment periods {i.e. during 2-week washout period}, and Day 1-14 in each treatment period]), then in treatment period 2 participants received oxycodone controlled release 10 mg (20 mg/day) capsule orally twice daily on Days 1-14 followed by celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14 in treatment period 3. Each 2-week treatment period was separated by a 2-week washout period. |
| FG002 | Celecoxib Then Placebo Then Oxycodone | Participants received celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14 of treatment period 1 then, in treatment period 2 participants received placebo capsules matched to celecoxib and oxycodone orally, twice daily from Day 1 to 14 (participants received placebo from Days 1 to 84 in 3 treatment periods [14 days prior to each treatment periods {i.e. during 2-week washout period}, and Day 1-14 in each treatment period]), followed by oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14 in treatment period 3. Each 2-week treatment period was separated by a 2-week washout period. |
| FG003 | Celecoxib Then Oxycodone Then Placebo | Participants received celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14 of treatment period 1, then in treatment period 2 participants received oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14, followed by placebo capsules matched to celecoxib and oxycodone orally, twice daily from Day 1 to 14 of treatment period 3 (participants received placebo from Days 1 to 84 in 3 treatment periods [14 days prior to each treatment periods {i.e. during 2-week washout period}, and Day 1-14 in each treatment period]). Each 2-week treatment period was separated by a 2-week washout period. |
| FG004 | Oxycodone Then Placebo Then Celecoxib | Participants received oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14 in treatment period 1 then, in treatment period 2 participants received placebo capsules matched to celecoxib and oxycodone orally, twice daily from Day 1 to 14 (participants received placebo from Days 1 to 84 in 3 treatment periods [14 days prior to each treatment periods {i.e. during 2-week washout period}, and Day 1-14 in each treatment period]), followed by celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14 in treatment period 3. Each 2-week treatment period was separated by a 2-week washout period. |
| FG005 | Oxycodone Then Celecoxib Then Placebo | Participants received oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14 in treatment period 1 then, in treatment period 2 participants received celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14, followed by placebo capsules matched to celecoxib and oxycodone orally, twice daily from Day 1 to 14 of treatment period 3 (participants received placebo from Days 1 to 84 in 3 treatment periods [14 days prior to each treatment periods {i.e. during 2-week washout period}, and Day 1-14 in each treatment period]). Each 2-week treatment period was separated by a 2-week washout period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (2 Weeks) |
| |||||||||||||
| Washout Period (2 Weeks) |
| |||||||||||||
| Treatment Period 2 (2 Weeks) |
| |||||||||||||
| Washout Period (2 Weeks) |
| |||||||||||||
| Treatment Period 3 (2 Weeks) |
|
Baseline analysis population included all randomized participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All randomized participants who received placebo matched to celecoxib and oxycodone, celecoxib 100 mg and oxycodone 20 mg orally, twice daily in one of the 6 treatment sequences in each of three treatment periods. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Knee Pain Intensity Measured by Numeric Rating Scale (NRS) at Week 12 | The severity of arthritis pain in participant's signal knee at the time of the visit was assessed using an 11-point NRS, ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. | As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis. | Posted | Baseline, Week 12 |
|
From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo capsules matched to celecoxib and oxycodone orally, twice daily from Day 1 to 84 (Days 1-14 of treatment periods 1, 2, 3 and for 14 days prior to each of three treatment periods [i.e. during 2-week washout period]) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA v12.0 | Non-systematic Assessment |
No efficacy analysis were conducted, as this study was stopped due to a high screen failure rate before the planned enrollment required to carry out the pre-specified efficacy analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Not provided
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Drug |
oral, 20 mg bid |
|
| placebo | Drug | oral bid |
|
| Baseline, Week 12 |
| Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Stiffness Subscale Score at Week 12 | WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). Stiffness was defined as a sensation of decreased ease of movement in study joint. The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the in the study joint during the past 48 hours. The WOMAC stiffness subscale score for each question ranges from 0 (minimum) to 4 (maximum), higher scores signifies worse stiffness. The stiffness subscale score ranges from 0 to 8, where higher scores indicated worse stiffness. | Baseline, Week 12 |
| Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Total Score at Week 12 | WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). The WOMAC composite index was the sum of 24 individual questions regarding subscales of pain, stiffness and physical function (for each item score range: 0 [minimum] to 4 [maximum], higher score indicating worse study joint condition). Total score was sum of the 3 subscale scores, giving a possible overall score range of 0 (minimum) to 96 (maximum). Higher score indicating the worse level of pain, stiffness and physical function. | Baseline, Week 12 |
| Change From Baseline in Knee Adduction Moment at Week 12 | Adduction (external) moment was defined as the ground-generated torque that forces the distal tibia toward the midline of the body, which forces the knee away from the midline, into a varus or "bow-legged" position. External knee adduction moment was assessed as percent body weight*height (%BW*ht). | Baseline, Week 12 |
| Change From Baseline in Quadriceps Inhibition at Week 12 | Quadriceps inhibition was assessed in terms of flexion-extension range of motion and normalized mid stance knee flexion angle in degrees. | Baseline, Week 12 |
| Change From Baseline in Peak Ground Reaction Force at Week 12 | Change from baseline in peak ground reaction force in body weight*seconds (BW*sec) was assessed with the help of a multicomponent force plate. | Baseline, Week 12 |
| Change From Baseline in Total Ground Reaction Force at Week 12 | Change from baseline in total ground reaction force in body weight*seconds was assessed with the help of a multicomponent force plate. | Baseline, Week 12 |
| Change From Baseline in Stride Length at Week 12 | The level walking was assessed by stride length; assessment was done based on 6 stride cycles over a range of walking speeds. | Baseline, Week 12 |
| Change From Baseline in Walking Speed at Week 12 | Change from baseline in walking speed in meters per second was assessed. | Baseline, Week 12 |
| Change From Baseline in Cadence at Week 12 | Cadence was defined as the rate at which a person walk, expressed in steps per minute. | Baseline, Week 12 |
| Change From Baseline in Patient Global Assessment of Arthritic Condition (PGAAC) Score at Week 12 | The PGAAC is self-administered measure in which participants answered the following question: "considering all the ways the OA in your signal knee affects you, how are you doing today?". Participants rated their condition using the following scale: 1= very good (no symptoms and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition. | Baseline, Week 12 |
| Stanford |
| California |
| 94305 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Celecoxib 100 mg |
Participants received celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14 in each of three treatment periods (each 2-week treatment period was separated by a 2-week washout period). |
| OG002 | Oxycodone 20 mg | Participants received oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14 in each of three treatment periods (each 2-week treatment period was separated by a 2-week washout period). |
|
| Primary | Change From Baseline in Knee Pain Intensity Measured by Visual Analog Scale (VAS) at Week 12 | The severity of arthritis pain in participant's signal knee was assessed using a 100-millimeter (mm) VAS ranging from 0 mm = no pain and 100 mm = most severe pain. Higher score indicate more pain. | As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis. | Posted | Baseline, Week 12 |
|
|
| Primary | Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Pain Subscale Score at Week 12 | WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). The index consists of 24 questions (5 pain, 2 stiffness, and 17 physical function). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of to be replaced/replaced index joint (knee or hip) during past 48 hours. The WOMAC pain subscale score for each question ranges from 0 (minimum) to 4 (maximum), higher scores signifies worse pain. Pain subscale total score ranges from 0 to 20, with higher scores indicating worse pain. | As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis. | Posted | Baseline, Week 12 |
|
|
| Primary | Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Physical Function Subscale Score at Week 12 | WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in in the study joint during past 48 hours. The WOMAC physical function subscale score for each question ranges from 0 (minimum) to 4 (maximum), higher scores signifies worse physical function. Physical function subscale scores range from 0 to 68, where higher scores indicated more difficulty in performing daily activities. | As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis. | Posted | Baseline, Week 12 |
|
|
| Primary | Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Stiffness Subscale Score at Week 12 | WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). Stiffness was defined as a sensation of decreased ease of movement in study joint. The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the in the study joint during the past 48 hours. The WOMAC stiffness subscale score for each question ranges from 0 (minimum) to 4 (maximum), higher scores signifies worse stiffness. The stiffness subscale score ranges from 0 to 8, where higher scores indicated worse stiffness. | As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis. | Posted | Baseline, Week 12 |
|
|
| Primary | Change From Baseline in Western Ontario and McMaster (WOMAC) Osteoarthritis Index Total Score at Week 12 | WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). The WOMAC composite index was the sum of 24 individual questions regarding subscales of pain, stiffness and physical function (for each item score range: 0 [minimum] to 4 [maximum], higher score indicating worse study joint condition). Total score was sum of the 3 subscale scores, giving a possible overall score range of 0 (minimum) to 96 (maximum). Higher score indicating the worse level of pain, stiffness and physical function. | As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis. | Posted | Baseline, Week 12 |
|
|
| Primary | Change From Baseline in Knee Adduction Moment at Week 12 | Adduction (external) moment was defined as the ground-generated torque that forces the distal tibia toward the midline of the body, which forces the knee away from the midline, into a varus or "bow-legged" position. External knee adduction moment was assessed as percent body weight*height (%BW*ht). | As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis. | Posted | Baseline, Week 12 |
|
|
| Primary | Change From Baseline in Quadriceps Inhibition at Week 12 | Quadriceps inhibition was assessed in terms of flexion-extension range of motion and normalized mid stance knee flexion angle in degrees. | As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis. | Posted | Baseline, Week 12 |
|
|
| Primary | Change From Baseline in Peak Ground Reaction Force at Week 12 | Change from baseline in peak ground reaction force in body weight*seconds (BW*sec) was assessed with the help of a multicomponent force plate. | As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis. | Posted | Baseline, Week 12 |
|
|
| Primary | Change From Baseline in Total Ground Reaction Force at Week 12 | Change from baseline in total ground reaction force in body weight*seconds was assessed with the help of a multicomponent force plate. | As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis. | Posted | Baseline, Week 12 |
|
|
| Primary | Change From Baseline in Stride Length at Week 12 | The level walking was assessed by stride length; assessment was done based on 6 stride cycles over a range of walking speeds. | As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis. | Posted | Baseline, Week 12 |
|
|
| Primary | Change From Baseline in Walking Speed at Week 12 | Change from baseline in walking speed in meters per second was assessed. | As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis. | Posted | Baseline, Week 12 |
|
|
| Primary | Change From Baseline in Cadence at Week 12 | Cadence was defined as the rate at which a person walk, expressed in steps per minute. | As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis. | Posted | Baseline, Week 12 |
|
|
| Primary | Change From Baseline in Patient Global Assessment of Arthritic Condition (PGAAC) Score at Week 12 | The PGAAC is self-administered measure in which participants answered the following question: "considering all the ways the OA in your signal knee affects you, how are you doing today?". Participants rated their condition using the following scale: 1= very good (no symptoms and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition. | As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis. | Posted | Baseline, Week 12 |
|
|
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | Celecoxib 100 mg | Participants received celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14 in each of three treatment periods (each 2-week treatment period was separated by a 2-week washout period). | 0 | 6 | 4 | 6 |
| EG002 | Oxycodone 20 mg | Participants received oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14 in each of three treatment periods (each 2-week treatment period was separated by a 2-week washout period). | 0 | 6 | 6 | 6 |
| Constipation | Gastrointestinal disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA v12.0 | Non-systematic Assessment |
|
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.
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |