A Study on Diclofenac vs. Placebo for Knee Osteoarthritis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Nbcd A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

1 Aug 2024 → ongoing

Decision date (initial)

2024-07-05

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

NBCD A/S

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess the impact of a Placebo Response Mitigation Script (PRMS) on patient-reported knee pain.

Secondary objectives 3

1. To assess how the PRMS affects pain outcomes.
2. To assess how the PRMS affects other symptomatic outcomes.
3. To assess if the PRMS affects the proportion of responders.

Conditions and MedDRA coding

Knee osteoarthritis

Study design 1 period

Regulatory references

Plan to share IPD

Yes

IPD plan description

Data obtained through this study may be provided to qualified researchers on request in accordance with international principles for responsible research (under the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA)). Approval of the request (including e.g. research proposal and statistical analysis plan) and execution of all applicable agreements (i.e. a data sharing agreement) are prerequisites to the sharing of data with the requesting party. Data will only be shared in encoded form to protect participant identity and with requirements for data protection as well as requirements against unauthorized use and disclosure. Data will be made accessible for up to 24 months and extensions will be considered on a case-by-case basis. Participant identity will remain confidential. Participants can inquire about data transfers and security measures at any time by contacting the trial physician.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Signed ICF.
2. Able to attend all study sessions and comply with all procedures and rules regarding allowed study medication.
3. Male or female participants between the age of 40 to 85 years at the time of signing the ICF.
4. Body Mass Index (BMI) less than 45 kg/m2.
5. History of knee pain on most days for at least 3 months prior to screening.
6. Knee pain score of at least 40 out of 100 in response to the KOOS pain questionnaire at both the screening and the baseline visits.
7. Kellgren-Lawrence radiological grade of ≥2 in at least one of the tibio-femoral joints diagnosed by screening fixed-flexion anterior-posterior radiograph.

Exclusion criteria 9

1. Inability to communicate or cooperate with the investigator or to comply with the requirements of the entire study.
2. History of significant knee trauma (e.g., intra-articular fracture) or knee surgery (excluding injection therapies and arthroscopy) within the previous 1 year or previous knee arthroplasty.
3. Medical history and/or clinical findings (including ECG) of cardiac disease that in the opinion of the investigator are considered of clinical significance, including but not limited to established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
4. Known history of hypersensitivity to Diclofenac.
5. Medical history of gastrointestinal bleeding.
6. Use of coumarin derivatives (e.g. warfarin).
7. Known severe kidney and/or liver function impairment.
8. Pregnancy.
9. Other factors, e.g. self-reported drug abuse, which in the opinion of the investigator may interfere with the performance of the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline to end of study (EoS) in Knee Injury and Osteoarthritis Outcome Score (KOOS) pain between the active and the placebo group with the PRMS.

Secondary endpoints 8

1. Change from baseline to EoS in KOOS pain.
2. Change from baseline to EoS in ICOAP constant pain, intermittent pain, and the total ICOAP score.
3. Difference in the observed standard deviation of the change from baseline to EoS in KOOS pain and ICOAP.
4. Changes from baseline to EoS in pressure pain threshold (PPT) at relevant locations, temporal summation of pain (TSP), and conditioned pain modulation (CPM).
5. Change from baseline to EoS in KOOS function.
6. Change from baseline to EoS in “40-meter walk test”.
7. Change from baseline to EoS in number of placebo responders (≥30% and ≥50%).
8. Change from baseline to EoS in number of subjects meeting the OMERACT-OARSI responder criteria.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Nbcd A/S

Sponsor organisation

NBCD A/S

Address

Telefonvej 8d

City

Soeborg

Postcode

2860

Country

Denmark

Scientific contact point

Organisation

NBCD A/S

Contact name

Jakob Mejdahl Bentin

Public contact point

Organisation

NBCD A/S

Contact name

Jakob Mejdahl Bentin

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications