Trial · NCT01124006

A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of 2 Doses of Intradiscal rhGDF-5 (Single Administration) for the Treatment of Early Stage Lumbar Disc Degeneration

NCT01124006, Phase 2, Completed, DePuy Spine; results first posted 2016-02-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of 2 Doses of Intradiscal rhGDF-5 (Single Administration) for the Treatment of Early Stage Lumbar Disc Degeneration. Trials, record NCT01124006. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01124006

On this page

Trial

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

Title: A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of 2 Doses of Intradiscal rhGDF-5 (Single Administration) for the Treatment of Early Stage Lumbar Disc Degeneration
NCT number: NCT01124006
Status: Completed
Phases: Phase 2
Enrollment: 24 participants, actual
Lead sponsor: DePuy Spine
Conditions: Degenerative Disc Disease
Interventions: Intradiscal rhGDF-5, Water for injection
First posted: 2010-05-14
Last updated: 2016-02-24
Results first posted: 2016-02-24

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Neurological Assessment for Motor Function and Reflexes/Sensory	12 months	Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months. For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance. For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs.
Primary	Treatment Emergent Adverse Events- Relationship to Study Drug	Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up.	Number of patients with Treatment Emergent Adverse Events that were designated as Definitely Related to Study Drug.
Primary	Treatment Emergent Adverse Events- Relationship to Study Drug	12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up	Number of patients with Treatment Emergent Adverse Events that were designated as Possibly or Probably Related to Study Drug.
Secondary	Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.	12-month	The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.
Secondary	Change in Pain Visual Analogue Scale (VAS) at 12 Months From Baseline.	12 months	The Visual Analogue Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line ( that is approximately 10cm long) with 'No Pain' (score of 0=0cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.
Secondary	Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.	12 months	The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component- PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health)
Secondary	Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline.	12 months	The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component- PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health)

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Neurological Assessment for Motor Function and Reflexes/Sensory	12 months	Safety Population~For the Neurological Assessment at 12 months, only 8 subjects from the rhGDF-5 1.0mg group (out of 10 subjects total) completed the assessment, only 3 subjects from the rhGDF-5 2.0mg group (out of 4 subjects total) completed the assessment, and none of the placebo subjects (out of 10 total subjects) completed the assessment.	participants	NUMBER
SECONDARY	Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.	12-month	FAS Population	units on a scale	MEAN
SECONDARY	Change in Pain Visual Analogue Scale (VAS) at 12 Months From Baseline.	12 months	FAS Population	units on a scale	MEAN
SECONDARY	Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.	12 months	FAS Population~One subject from the rhGDF-5 1.0mg group (out of 10 subjects total) did not complete the PCS, SF-36 at Baseline.	units on a scale	MEAN
SECONDARY	Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline.	12 months	FAS Population~One subject from the rhGDF-5 1.0mg group (out of 10 subjects total) did not complete the MCS, SF-36 at Baseline.	units on a scale	MEAN
PRIMARY	Treatment Emergent Adverse Events- Relationship to Study Drug	Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up.	Safety Population	participants	NUMBER
PRIMARY	Treatment Emergent Adverse Events- Relationship to Study Drug	12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up	Safety Population	participants	NUMBER

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Value	Spread	Units
Neurological Assessment for Motor Function and Reflexes/Sensory	Intradiscal rhGDF-5 (1.0mg)	0		participants
Neurological Assessment for Motor Function and Reflexes/Sensory	Intradiscal rhGDF-5 (2.0mg)	0		participants
Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.	Intradiscal rhGDF-5 (1.0mg)	-19.8	Standard Deviation 21.22	units on a scale
Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.	Placebo	-18.8	Standard Deviation 22.43	units on a scale
Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.	Intradiscal rhGDF-5 (2.0mg)	-6.0	Standard Deviation 29.98	units on a scale
Change in Pain Visual Analogue Scale (VAS) at 12 Months From Baseline.	Intradiscal rhGDF-5 (1.0mg)	-2.33	Standard Deviation 3.645	units on a scale
Change in Pain Visual Analogue Scale (VAS) at 12 Months From Baseline.	Placebo	-2.78	Standard Deviation 3.751	units on a scale
Change in Pain Visual Analogue Scale (VAS) at 12 Months From Baseline.	Intradiscal rhGDF-5 (2.0mg)	-1.10	Standard Deviation 3.336	units on a scale
Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.	Intradiscal rhGDF-5 (1.0mg)	7.22	Standard Deviation 9.728	units on a scale
Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.	Placebo	8.61	Standard Deviation 14.213	units on a scale

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Intradiscal rhGDF-5 (1.0mg)	10
Overall Study	STARTED	Placebo	10
Overall Study	STARTED	Intradiscal rhGDF-5 (2.0mg)	4
Overall Study	COMPLETED	Intradiscal rhGDF-5 (1.0mg)	7
Overall Study	COMPLETED	Placebo	8
Overall Study	COMPLETED	Intradiscal rhGDF-5 (2.0mg)	2
Overall Study	NOT COMPLETED	Intradiscal rhGDF-5 (1.0mg)	3
Overall Study	NOT COMPLETED	Placebo	2
Overall Study	NOT COMPLETED	Intradiscal rhGDF-5 (2.0mg)	2

Source ClinicalTrials.gov

Adverse events165

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	Events
other	Back Pain	Musculoskeletal and connective tissue disorders	Intradiscal rhGDF-5 (1.0mg)	5	10	18
other	Back Pain	Musculoskeletal and connective tissue disorders	Placebo	6	10	9
other	Back Pain	Musculoskeletal and connective tissue disorders	Intradiscal rhGDF-5 (2.0mg)	3	4	6
other	Arthralgia	Musculoskeletal and connective tissue disorders	Intradiscal rhGDF-5 (1.0mg)	1	10	1
other	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo	3	10	3
other	Arthralgia	Musculoskeletal and connective tissue disorders	Intradiscal rhGDF-5 (2.0mg)	1	4	4
other	Pain in Extremity	Musculoskeletal and connective tissue disorders	Intradiscal rhGDF-5 (1.0mg)	0	10	0
other	Pain in Extremity	Musculoskeletal and connective tissue disorders	Placebo	0	10	0
other	Pain in Extremity	Musculoskeletal and connective tissue disorders	Intradiscal rhGDF-5 (2.0mg)	3	4	3
other	Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	Intradiscal rhGDF-5 (1.0mg)	0	10	0

1 to 10 of 165Source ClinicalTrials.gov

See all 165 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intradiscal rhGDF-5 (1.0mg)
Total, all-cause mortality	Placebo
Total, all-cause mortality	Intradiscal rhGDF-5 (2.0mg)
Total, other adverse events	Intradiscal rhGDF-5 (1.0mg)	9	10
Total, other adverse events	Placebo	10	10
Total, other adverse events	Intradiscal rhGDF-5 (2.0mg)	4	4
Total, serious adverse events	Intradiscal rhGDF-5 (1.0mg)	0	10
Total, serious adverse events	Placebo	0	10
Total, serious adverse events	Intradiscal rhGDF-5 (2.0mg)	2	4

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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/NCT01124006

GET https://conductscience.org/api/trials/v1/NCT01124006/events?page=2

API reference For AI assistants