Trial · NCT01091116

A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS

NCT01091116, Phase 2, Completed, Menarini Group; results first posted 2013-02-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS. Trials, record NCT01091116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01091116

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Trial

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

Title: A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS
NCT number: NCT01091116
Status: Completed
Phases: Phase 2
Enrollment: 423 participants, actual
Lead sponsor: Menarini Group
Conditions: Osteoarthritis, Knee
Interventions: MEN16132 - 0.125 mg, MEN16132 - 0.25 mg, MEN16132 - 0.5 mg, MEN16132 - 0.5 mg, Placebo
First posted: 2010-03-23
Last updated: 2013-02-18
Other registries' IDs: eudract:2009-014918-99
Results first posted: 2013-02-18

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	WOMAC VA 3.1 A Score (Total Pain)	over the 3 weeks after the first administration	Western Ontario and McMaster Universities osteoarthritis index (WOMAC). The WOMAC VA 3.1 A score (total pain , range 0-500 mm) is the sum of VAS scores (0-100 mm) attributed by the patient to each of the 5 questions referring to osteoarthritic pain experienced during the preceding 48 hours. The higher is the WOMAC VA 3.1 A score, the higher is the intensity of pain symptoms (0 = no pain ; 500 = extreme pain). A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom. The change from baseline was assessed along 3 weeks after first drug administrations.
Secondary	WOMAC VA 3.1.B Score (Knee Stiffness)	up to 3 months after first dose	WOMAC VA 3.1.B score(range 0-200) is the sum of VAS scores (0-100 mm)attributed by the patient to each of the 2 questions referring to joint stiffness experienced during the preceding 48 hours. The higher is the WOMAC VA 3.1 B score, the higher is joint stiffness (0 = no stiffness ; 200 = extreme stiffness). A decrease of the WOMAC VA 3.1 B score following treatment administration indicates a reduction of joint stiffness. The change at Week 13 from baseline is reported.
Secondary	WOMAC VA 3.1. C Score (Function)	up to 3 months after first dose	Knee function evaluated by WOMAC VA 3.1 C score (range 0-1700) is the sum of VAS scores (range 0-100 mm) attributed by the patient to each of 17 questions referring to difficulty in performing daily activities experienced during the preceding 48 hours. The higher is the WOMAC VA 3.1 C score, the higher is functional impairment in daily activities (0 = no difficulty ; 1700 = extreme difficulty). A decrease of the WOMAC VA 3.1 C score following treatment administration indicates an improvement in performing daily activities. WOMAC VA 3.1.C scores at baseline and at Week 13 are reported.
Secondary	Percentage of Treatment Responders According to OMERACT-OARSI Responder Criteria	up to 3 months after first dose	Osteoarthritis Research Society International (OARSI). Response defined as: * a decrease in WOMAC pain or physical-function score by 50% or more and by 20 or more points on the visual analogue scale * OR if two of the following three findings are recorded: a decrease in the WOMAC pain score by 20% or more and by 10 or more points on the visual analogue scale; a decrease in the WOMAC physical-function score by 20% or more and by 10 or more points on the scale; an improvement in the score on the patient's global assessment by 20% or more and by 10 or more points on the scale.
Secondary	Patient Global Assessment	up to 3 months after first dose	Patient global assessment evaluated using a VAS scale score attributed by the patient (range 0-100 mm). Efficacy assessed as change at each time-point post-dosing (week 1, 2 ,3, 13) versus baseline (week 0). A decrease of patient global assessment score indicates an improvement of osteoarthritis symptoms.
Secondary	WOMAC VA 3.1A - Total Pain Score by Body Mass Index [BMI <= 25]	over the 3 weeks after the first administration	Analysis in normal-weight population (BMI \<= 25) of the WOMAC VA 3.1A score (range 0-500 mm) is reported. A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom.
Secondary	WOMAC VA 3.1A - Total Pain Score by Body Mass Index -[BMI > 25]	over the 3 weeks after the first administration	Analysis in over-weight population (BMI \> 25) of the WOMAC VA 3.1A score (range 0-500 mm) is reported. A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom.
Secondary	Adverse Event Reports	up to 4 months after screening	Incidence of spontaneously reported adverse events
Secondary	Clinically Significant Abnormal Laboratory Tests	up to 4 months from screening	Percentage of patients with Abnormal Laboratory Tests judged Clinically Significant by Investigators. The following hematochemical and urinary parameters were analysed: Red Blood Cells Count, Haematocrit, Haemoglobin, Platelets, MCV, MCH, MCHC, White Blood Cells, Sodium, Chloride, Potassium, Total calcium, AST (SGOT), ALT (SGPT), GGT, Alkaline phosphatase, Total Bilirubin, Direct Bilirubin, Creatinine, BUN, CPK, LDH, Glucose, Total proteins, Albumin.

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	WOMAC VA 3.1 A Score (Total Pain)	over the 3 weeks after the first administration	analysis of the intention to treat (ITT) population	mm	MEAN
SECONDARY	WOMAC VA 3.1.B Score (Knee Stiffness)	up to 3 months after first dose	Intention to Treat (ITT) population	mm	MEAN
SECONDARY	WOMAC VA 3.1. C Score (Function)	up to 3 months after first dose	Intention to Treat (ITT) population	mm	MEAN
SECONDARY	Percentage of Treatment Responders According to OMERACT-OARSI Responder Criteria	up to 3 months after first dose	intention to treat (ITT) population	percentage of patients	NUMBER
SECONDARY	Patient Global Assessment	up to 3 months after first dose	intention to treat (ITT) population	mm	MEAN
SECONDARY	WOMAC VA 3.1A - Total Pain Score by Body Mass Index [BMI <= 25]	over the 3 weeks after the first administration	Population of Normal Weight patients (BMI \<=25)	mm	MEAN
SECONDARY	WOMAC VA 3.1A - Total Pain Score by Body Mass Index -[BMI > 25]	over the 3 weeks after the first administration	Population of Over Weight patients (BMI \>25)	mm	MEAN
SECONDARY	Adverse Event Reports	up to 4 months after screening	The number of patients reflects all patients administered at least one dose of the investigational product.	participants	NUMBER
SECONDARY	Clinically Significant Abnormal Laboratory Tests	up to 4 months from screening	Percentage of patients with clinically significant abnormal laboratory tests	participants	NUMBER

Source ClinicalTrials.gov

Results by group245

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

Outcome	Group	Category	Value	Spread	Units
WOMAC VA 3.1 A Score (Total Pain)	Low Dose	1 week post dose 1	-60	Standard Deviation 84	mm
WOMAC VA 3.1 A Score (Total Pain)	Mid Dose	1 week post dose 1	-58	Standard Deviation 82	mm
WOMAC VA 3.1 A Score (Total Pain)	High Dose	1 week post dose 1	-52	Standard Deviation 92	mm
WOMAC VA 3.1 A Score (Total Pain)	Single High Dose	1 week post dose 1	-67	Standard Deviation 91	mm
WOMAC VA 3.1 A Score (Total Pain)	Placebo	1 week post dose 1	-63	Standard Deviation 103	mm
WOMAC VA 3.1 A Score (Total Pain)	Low Dose	2 weeks post dose 1	-69	Standard Deviation 89	mm
WOMAC VA 3.1 A Score (Total Pain)	Mid Dose	2 weeks post dose 1	-65	Standard Deviation 81	mm
WOMAC VA 3.1 A Score (Total Pain)	High Dose	2 weeks post dose 1	-71	Standard Deviation 102	mm
WOMAC VA 3.1 A Score (Total Pain)	Single High Dose	2 weeks post dose 1	-73	Standard Deviation 96	mm
WOMAC VA 3.1 A Score (Total Pain)	Placebo	2 weeks post dose 1	-75	Standard Deviation 93	mm

1 to 10 of 245Source ClinicalTrials.gov

See all 245 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Low Dose	83
Overall Study	STARTED	Mid Dose	88
Overall Study	STARTED	High Dose	84
Overall Study	STARTED	Single High Dose	84
Overall Study	STARTED	Placebo	84
Overall Study	COMPLETED	Low Dose	77
Overall Study	COMPLETED	Mid Dose	80
Overall Study	COMPLETED	High Dose	73
Overall Study	COMPLETED	Single High Dose	80
Overall Study	COMPLETED	Placebo	73

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events100

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	Injection site pain	General disorders	Low Dose	2	83	2
other	Injection site pain	General disorders	Mid Dose	3	88	3
other	Injection site pain	General disorders	High Dose	3	83	3
other	Injection site pain	General disorders	Single High Dose	2	83	2
other	Injection site pain	General disorders	Placebo	1	84	1
other	Nasopharyngitis	Infections and infestations	Low Dose	5	83	5
other	Nasopharyngitis	Infections and infestations	Mid Dose	5	88	5
other	Nasopharyngitis	Infections and infestations	High Dose	4	83	4
other	Nasopharyngitis	Infections and infestations	Single High Dose	4	83	5
other	Nasopharyngitis	Infections and infestations	Placebo	5	84	6

1 to 10 of 100Source ClinicalTrials.gov

See all 100 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Low Dose
Total, all-cause mortality	Mid Dose
Total, all-cause mortality	High Dose
Total, all-cause mortality	Single High Dose
Total, all-cause mortality	Placebo
Total, other adverse events	Low Dose	17	83
Total, other adverse events	Mid Dose	18	88
Total, other adverse events	High Dose	21	83
Total, other adverse events	Single High Dose	15	83
Total, other adverse events	Placebo	16	84

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

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/NCT01091116

GET https://conductscience.org/api/trials/v1/NCT01091116/results?page=2

API reference For AI assistants