Trial · NCT01158924
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
NCT01158924, Phase 1, Phase 2, Completed, DePuy Spine; results first posted 2016-01-27
3 sourcestrials-2026-11-12-0.5.0
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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 NCT01158924. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01158924
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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
- NCT01158924
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- DePuy Spine
- Conditions
- Early Lumbar Disc Degeneration
- Interventions
- Intradiscal rhGDF-5
- First posted
- 2010-07-08
- Last updated
- 2016-02-26
- Results first posted
- 2016-01-27
Source ClinicalTrials.gov
Registered outcomes5
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 related or possibly related to Study Drug. |
| Secondary | Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline | 12 months | 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). |
Source ClinicalTrials.gov
Outcomes5
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~The Neurological Assessment at 12 months was only conducted on 13 subjects from the 1.0mg group (out of 14 total subjects) and 25 subjects from the 2.0 mg group (out of 26 total). | participants | NUMBER |
| SECONDARY | Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline | 12 months | 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 |
| 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 | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | 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) | 2 | participants | ||
| Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline | Intradiscal rhGDF-5 (1.0mg) | -13.0 | Standard Deviation 14.63 | units on a scale | |
| Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline | Intradiscal rhGDF-5 (2.0mg) | -18.1 | Standard Deviation 13.69 | units on a scale | |
| Treatment Emergent Adverse Events- Relationship to Study Drug | Intradiscal rhGDF-5 (1.0mg) | 2 | participants | ||
| Treatment Emergent Adverse Events- Relationship to Study Drug | Intradiscal rhGDF-5 (2.0mg) | 1 | participants | ||
| Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline. | Intradiscal rhGDF-5 (1.0mg) | -2.66 | Standard Deviation 3.448 | units on a scale | |
| Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline. | Intradiscal rhGDF-5 (2.0mg) | -3.80 | Standard Deviation 2.651 | 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) | 11.18 | Standard Deviation 13.206 | 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 (2.0mg) | 10.00 | Standard Deviation 9.897 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intradiscal rhGDF-5 (1.0mg) | 14 | |
| Overall Study | STARTED | Intradiscal rhGDF-5 (2.0mg) | 26 | |
| Overall Study | COMPLETED | Intradiscal rhGDF-5 (1.0mg) | 13 | |
| Overall Study | COMPLETED | Intradiscal rhGDF-5 (2.0mg) | 23 | |
| Overall Study | NOT COMPLETED | Intradiscal rhGDF-5 (1.0mg) | 1 | |
| Overall Study | NOT COMPLETED | Intradiscal rhGDF-5 (2.0mg) | 3 |
Source ClinicalTrials.gov
Adverse events82
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) | 3 | 14 | 7 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Intradiscal rhGDF-5 (2.0mg) | 12 | 26 | 20 |
| other | Neck Pain | Musculoskeletal and connective tissue disorders | Intradiscal rhGDF-5 (1.0mg) | 0 | 14 | 0 |
| other | Neck Pain | Musculoskeletal and connective tissue disorders | Intradiscal rhGDF-5 (2.0mg) | 2 | 26 | 2 |
| other | Pain in Extremity | Musculoskeletal and connective tissue disorders | Intradiscal rhGDF-5 (1.0mg) | 1 | 14 | 1 |
| other | Pain in Extremity | Musculoskeletal and connective tissue disorders | Intradiscal rhGDF-5 (2.0mg) | 0 | 26 | 0 |
| other | Influenza | Infections and infestations | Intradiscal rhGDF-5 (1.0mg) | 0 | 14 | 0 |
| other | Influenza | Infections and infestations | Intradiscal rhGDF-5 (2.0mg) | 2 | 26 | 2 |
| other | Lower Respiratory Tract Infection | Infections and infestations | Intradiscal rhGDF-5 (1.0mg) | 1 | 14 | 1 |
| other | Lower Respiratory Tract Infection | Infections and infestations | Intradiscal rhGDF-5 (2.0mg) | 1 | 26 | 1 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
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 | Intradiscal rhGDF-5 (2.0mg) | ||
| Total, other adverse events | Intradiscal rhGDF-5 (1.0mg) | 12 | 14 |
| Total, other adverse events | Intradiscal rhGDF-5 (2.0mg) | 18 | 26 |
| Total, serious adverse events | Intradiscal rhGDF-5 (1.0mg) | 1 | 14 |
| Total, serious adverse events | Intradiscal rhGDF-5 (2.0mg) | 4 | 26 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intradiscal rhGDF-5 (1.0mg) vs Intradiscal rhGDF-5 (2.0mg): Neurological Assessment for Motor Function and Reflexes/Sensory | Trial comparisons |
| Intradiscal rhGDF-5 (1.0mg) vs Intradiscal rhGDF-5 (2.0mg): Treatment Emergent Adverse Events- Relationship to Study Drug | Trial comparisons |
| Intradiscal rhGDF-5 (1.0mg) vs Intradiscal rhGDF-5 (2.0mg): 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.
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/NCT01158924
GET https://conductscience.org/api/trials/v1/NCT01158924/events?page=2