Trial · NCT00565812

A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee

NCT00565812, Phase 2, Completed, Pfizer; results first posted 2016-12-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee. Trials, record NCT00565812. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00565812

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee
NCT number: NCT00565812
Status: Completed
Phases: Phase 2
Enrollment: 1,457 participants, actual
Lead sponsor: Pfizer
Conditions: Osteoarthritis
Interventions: SD-6010, SD-6010, Placebo
First posted: 2007-11-30
Last updated: 2016-12-30
Other registries' IDs: eudract:2007-001457-26
Results first posted: 2016-12-30

Source ClinicalTrials.gov

Registered outcomes44

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Rate of Progression of Joint Space Narrowing	Baseline up to Month 24	Rate of progression of joint space narrowing (JSN) was defined as narrowing in joint space width (JSW) over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in millimeter per year (mm/year) over a 2 year period was used to assess the rate of progression of JSN. Negative values indicating a worsening of osteoarthritis.
Primary	Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2	Baseline up to Month 24	Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 \[no severity\] to 4 \[maximum severity\], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.
Primary	Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3	Baseline up to Month 24	Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 \[no severity\] to 4 \[maximum severity\], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.
Secondary	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	The WOMAC was a self-administered, disease-specific instrument which probed clinically important, participant relevant symptoms in the areas of pain, stiffness, and physical function in participants with OA of the 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 knee 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.
Secondary	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	The WOMAC pain subscale was comprised of 5 questions regarding the amount of pain experienced due to OA in the study knee. The WOMAC pain subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse pain. An overall subscale score range of 0 (minimum) to 20 (maximum), with higher scores indicating more pain.
Secondary	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	Stiffness was defined as a sensation of decreased ease in which the participant moved the knee with OA. The WOMAC stiffness subscale was comprised of 2 questions regarding the degree of stiffness experienced in the study knee. The WOMAC stiffness subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse stiffness. An overall score range of 0 (minimum) to 8 (maximum), with higher scores indicating more stiffness.
Secondary	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	The WOMAC physical function subscale referred to the participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee. The WOMAC physical function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function. An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.
Secondary	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	Pain VAS was a self-administered instrument, a 100 millimeter (mm) line marked by participant. Intensity of pain range (over past week): 0 (mm) =no pain to 100 (mm) =worst possible pain. Higher score indicating severe pain.
Secondary	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using the scale ranging from 1 (minimum) to 5 (maximum), where 1 =very good, 2 =good, 3 =fair, 4 =poor and 5 =very poor. Higher scores indicating worse condition.
Secondary	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	Physician assessed the overall impact of arthritis on the participant's daily life. Participant's condition was rated by the physician using the scale ranging from 1 (minimum) to 5 (maximum), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicating worse condition.

1 to 10 of 44Source ClinicalTrials.gov

See all 44 registered outcomes

Outcomes44

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Rate of Progression of Joint Space Narrowing	Baseline up to Month 24	FAS included all participants randomized to the study. Here, 'number of participants analyzed' (N) signifies participants evaluable for this outcome measure.	mm/year	MEAN
PRIMARY	Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2	Baseline up to Month 24	FAS included all participants randomized to the study. Here, 'N' signifies participants with KLG \<=2 and evaluable for this outcome measure.	mm/year	MEAN
PRIMARY	Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3	Baseline up to Month 24	FAS included all participants randomized to the study. Here, 'N' signifies participants with KLG =3 and evaluable for this outcome measure.	mm/year	MEAN
SECONDARY	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.	units on a scale	MEAN
SECONDARY	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.	units on a scale	MEAN
SECONDARY	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.	units on a scale	MEAN
SECONDARY	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.	units on a scale	MEAN
SECONDARY	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.	mm	MEAN
SECONDARY	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.	units on a scale	MEAN
SECONDARY	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.	units on a scale	MEAN

1 to 10 of 44Source ClinicalTrials.gov

See all 44 outcomes

Results by group624

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Rate of Progression of Joint Space Narrowing	SD-0610 50 Milligram (mg)		-0.101	Standard Deviation 0.346	mm/year
Rate of Progression of Joint Space Narrowing	SD-0610 200 mg		-0.125	Standard Deviation 0.298	mm/year
Rate of Progression of Joint Space Narrowing	Placebo		-0.109	Standard Deviation 0.261	mm/year
Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2	SD-0610 50 Milligram (mg)		-0.061	Standard Deviation 0.335	mm/year
Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2	SD-0610 200 mg		-0.069	Standard Deviation 0.254	mm/year
Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2	Placebo		-0.075	Standard Deviation 0.221	mm/year
Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3	SD-0610 50 Milligram (mg)		-0.133	Standard Deviation 0.352	mm/year
Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3	SD-0610 200 mg		-0.162	Standard Deviation 0.319	mm/year
Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3	Placebo		-0.136	Standard Deviation 0.286	mm/year
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	SD-0610 50 Milligram (mg)	Baseline (n =481, 482, 481)	39.07	Standard Deviation 18.85	units on a scale

1 to 10 of 624Source ClinicalTrials.gov

See all 624 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SD-6010 50 Milligram (mg)	485
Overall Study	STARTED	SD-6010 200 mg	486
Overall Study	STARTED	Placebo	486
Overall Study	COMPLETED	SD-6010 50 Milligram (mg)	341
Overall Study	COMPLETED	SD-6010 200 mg	351
Overall Study	COMPLETED	Placebo	356
Overall Study	NOT COMPLETED	SD-6010 50 Milligram (mg)	144
Overall Study	NOT COMPLETED	SD-6010 200 mg	135
Overall Study	NOT COMPLETED	Placebo	130

Source ClinicalTrials.gov

Adverse events2,724

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	SD-6010 50 Milligram (mg)	2	482
other	Anaemia	Blood and lymphatic system disorders	SD-6010 200 mg	2	485
other	Anaemia	Blood and lymphatic system disorders	Placebo	9	485
other	Eosinophilia	Blood and lymphatic system disorders	SD-6010 50 Milligram (mg)	1	482
other	Eosinophilia	Blood and lymphatic system disorders	SD-6010 200 mg	1	485
other	Eosinophilia	Blood and lymphatic system disorders	Placebo	2	485
other	Hypochromasia	Blood and lymphatic system disorders	SD-6010 50 Milligram (mg)	0	482
other	Hypochromasia	Blood and lymphatic system disorders	SD-6010 200 mg	1	485
other	Hypochromasia	Blood and lymphatic system disorders	Placebo	1	485
other	Hypochromic anaemia	Blood and lymphatic system disorders	SD-6010 50 Milligram (mg)	0	482

1 to 10 of 2,724Source ClinicalTrials.gov

See all 2,724 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SD-6010 50 Milligram (mg)
Total, all-cause mortality	SD-6010 200 mg
Total, all-cause mortality	Placebo
Total, other adverse events	SD-6010 50 Milligram (mg)	365	482
Total, other adverse events	SD-6010 200 mg	371	485
Total, other adverse events	Placebo	360	485
Total, serious adverse events	SD-6010 50 Milligram (mg)	43	482
Total, serious adverse events	SD-6010 200 mg	61	485
Total, serious adverse events	Placebo	49	485

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23144445	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00565812

GET https://conductscience.org/api/trials/v1/NCT00565812/registered?page=2

API reference For AI assistants