Trial · NCT01182337

A Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration

NCT01182337, Phase 1, Phase 2, Completed, DePuy Spine; results first posted 2016-01-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration. Trials, record NCT01182337. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01182337

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Trial

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

Title: A Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration
NCT number: NCT01182337
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 31 participants, actual
Lead sponsor: DePuy Spine
Conditions: Early Lumbar Disc Degeneration
Interventions: Intradiscal rhGDF-5, Vehicle control
First posted: 2010-08-16
Last updated: 2016-02-26
Results first posted: 2016-01-27

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 Analog Scale (VAS) at 12 Months From Baseline.	12 months	The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) 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 21 subjects from the rhGDF-5 group completed the assessment (out of 22 total subjects) and 5 subjects from the Control group completed the assessment (out of 9 subjects total).	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
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
SECONDARY	Change in Pain Visual Analog 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~Only 21 subjects from the rhGDF-5 group (out of 22 total subjects) completed the baseline PCS, SF-36.	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~Only 21 subjects from the rhGDF-5 group (out of 22 subjects total) completed the MCS, SF-36.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group14

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	Vehicle Control	0		participants
Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.	Intradiscal rhGDF-5 1.0mg	-13.5	Standard Deviation 13.86	units on a scale
Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.	Vehicle Control	-10.4	Standard Deviation 8.98	units on a scale
Treatment Emergent Adverse Events- Relationship to Study Drug	Intradiscal rhGDF-5 1.0mg	0		participants
Treatment Emergent Adverse Events- Relationship to Study Drug	Vehicle Control	0		participants
Treatment Emergent Adverse Events- Relationship to Study Drug	Intradiscal rhGDF-5	0		participants
Treatment Emergent Adverse Events- Relationship to Study Drug	Vehicle Control	1		participants
Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.	Intradiscal rhGDF-5 1.0mg	-2.49	Standard Deviation 2.211	units on a scale
Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.	Vehicle Control	-1.42	Standard Deviation 3.177	units on a scale

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Intradiscal rhGDF-5 1.0mg	22
Overall Study	STARTED	Vehicle Control	9
Overall Study	COMPLETED	Intradiscal rhGDF-5 1.0mg	19
Overall Study	COMPLETED	Vehicle Control	7
Overall Study	NOT COMPLETED	Intradiscal rhGDF-5 1.0mg	3
Overall Study	NOT COMPLETED	Vehicle Control	2

Source ClinicalTrials.gov

Adverse events62

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	8	22	9
other	Back Pain	Musculoskeletal and connective tissue disorders	Vehicle Control	3	9	4
other	Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	Intradiscal rhGDF-5	4	22	5
other	Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	Vehicle Control	0	9	0
other	Pain in Extremity	Musculoskeletal and connective tissue disorders	Intradiscal rhGDF-5	3	22	3
other	Pain in Extremity	Musculoskeletal and connective tissue disorders	Vehicle Control	1	9	1
other	Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	Intradiscal rhGDF-5	2	22	2
other	Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	Vehicle Control	0	9	0
other	Abdominal Pain Upper	Gastrointestinal disorders	Intradiscal rhGDF-5	1	22	1
other	Abdominal Pain Upper	Gastrointestinal disorders	Vehicle Control	1	9	1

1 to 10 of 62Source ClinicalTrials.gov

See all 62 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intradiscal rhGDF-5
Total, all-cause mortality	Vehicle Control
Total, other adverse events	Intradiscal rhGDF-5	16	22
Total, other adverse events	Vehicle Control	5	9
Total, serious adverse events	Intradiscal rhGDF-5	5	22
Total, serious adverse events	Vehicle Control	2	9

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33945627	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 comparisons4

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

Comparison	Source
Intradiscal rhGDF-5 vs Vehicle Control: Treatment Emergent Adverse Events- Relationship to Study Drug	Trial comparisons
Intradiscal rhGDF-5 1.0mg vs Vehicle Control: Neurological Assessment for Motor Function and Reflexes/Sensory	Trial comparisons
Intradiscal rhGDF-5 1.0mg vs Vehicle Control: Treatment Emergent Adverse Events- Relationship to Study Drug	Trial comparisons
Intradiscal rhGDF-5 vs Vehicle Control: serious adverse events	Trial comparisons

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/NCT01182337

GET https://conductscience.org/api/trials/v1/NCT01182337/events?page=2

API reference For AI assistants