Study to evaluate the efficacy and safety of Collavant n2 in individuals with osteoarthritis of the knee
Scientific Title of Study
A randomised, double-blind, placebo-controlled study to evaluate the efficacy
and safety of Collavant n2 in individuals with osteoarthritis of the knee
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
BI/210903/COLL/OA Version: 1.0 Date: April 26, 2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Collavant n2 40 mg/day
2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days
Comparator Agent
Glucosamine hydrochloride & Chondroitin sulfate
2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days
Comparator Agent
Microcrystalline cellulose
2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days
Inclusion Criteria
Age From
40.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1. Male and females ≥ 40 to ≤ 75 years suffering from knee joint pain for atleast 3 months before screening.
2. Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
3. Pain VAS for knee joint pain ≥ 5 and ≤ 7 cm on a 10 cm scale at screening.
4. Radiographic evidence of grade II/III knee OA based on the Kellgren and Lawrence (KL) radiographic entry criteria for OA -
i Grade II: Antero-posterior weight-bearing knee radiograph demonstrates possible joint space narrowing (JSN) with definite osteophyte formation.
ii Grade III: Antero-posterior weight-bearing knee radiograph demonstrates definite joint space narrowing, multiple osteophyte formations, some sclerosis, and possible deformity of bony ends.
5. LAI score of ≥ 6 - ≤10 at screening.
6. Willing to stop the restricted dietary supplements, home-based remedies, and any other form of topical products or medications for knee joint pain relief or any other reason for the entire study duration.
(Note: only hot and cold fomentation will be allowed, and the participant has to record the daily frequency of fomentation in the diary. The hot/cold fomentation needs to be stopped 48 hours prior to all assessment visits.)
7. Willing to stop using rescue medication 48 hours prior to all assessment visits.
8. Using the western toilet at home and/or workplace.
9. Willingness to participate and comply with the study procedures and required visits.
10. Ability to understand and sign a written informed consent form, which must be completed before performing study-specific tasks.
11. Literate and have the ability to complete the study-based questionnaires and tasks.
12. Female participants of childbearing age must be willing to use the acceptable methods of contraception during the study.
ExclusionCriteria
Details
1 History of uncontrolled hypertension and/or systolic blood pressure ≥ 140
mmHg and/or diastolic blood pressure ≥ 90 mmHg.
2 Fasting blood glucose (FBG) > 125 mg/dl.
3 Radiographic evidence of Grade I or Grade IV OA based on the KL
radiographic criteria for osteoarthritis.
4 Any history of trauma, fractures, or surgery to the index joint.
5 Any planned surgery (diagnostic or therapeutic intervention) to the index
joint during the participation in the study.
6 History of use of corticosteroid, disease modifying drugs, glucosamine,
chondroitin, and intra-articular treatments including injections of
corticosteroid or hyaluronic acid within 6 months of the screening visit and
consumption of Omega-3 fatty acids or other joint health supplements within
15 days preceding the screening visit.
7 History of use of gabapentin within 6 weeks and/or methylcobalamin within
2 weeks prior to screening.
8 Known case of deformity of the knee joint or diagnosed on clinical
examination during screening.
9 Known case of any joint disorder involving the index joint that includes but
is not limited to known rheumatic or inflammatory conditions such as
rheumatoid arthritis, osteomyelitis, osteoporosis, severe OA, and bone
metastasis.
10 Known cases of gout and/or hyperuricemia (serum uric acid >440 μmol/L).
11 Other pathologic lesions on X-ray of the knee.
12 History of bleeding disorders (e.g., Haemophilia, Sickle cell anaemia, etc.).
13 Participants with abnormal levels of serum thyroid-stimulating hormone
(TSH) (< 0.4 to > 4.2 mIU/L).
14 Any history or evidence of allergy to chicken, eggs, or protein products in
the past.
15 Alcoholics or known drug dependents. (Alcoholism or heavy alcohol use is
interpreted based on alcohol content consumed per day or week. It is defined
as more than 4 drinks on any day or more than 14 drinks per week for men.
For women, it is defined as more than 3 drinks on any day or more than 7
drinks per week. Standard alcoholic drink is roughly equivalent to 14 grams
of pure alcohol, which is found in the following:
i 12 ounces (Approx. 350 ml) of regular beer, which is usually about 5%
alcohol
ii 5 ounces (Approx. 150 ml) of wine, which is typically about 12%
alcohol
iii 1.5 ounces (Approx. 45 ml) of distilled spirits, which is about 40%
alcohol)
16 History of smoking or currently smoking or using any form of smokeless
tobacco.
17 Not willing to abstain from the use of NSAIDs (including low dose aspirin
50 mg/day for cardiovascular health).
18 Participation in a study of an investigational product within 90 days prior to
the screening.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
To evaluate the effect of 6-month (180 days) consumption of Collavant n2 on
knee joint health as assessed by change in Western Ontario and McMaster
University Osteoarthritis Index (WOMAC) total score compared to placebo.
Day 0 and 180
Secondary Outcome
Outcome
TimePoints
Knee joint pain as assessed by the change in the WOMAC - Pain subscale
(WOMAC-P) score.
Day 0, 7, 30, 60, 90, 120, 150, and 180
Knee joint stiffness as assessed by the change in the WOMAC - Stiffness
subscale (WOMAC-S) score.
Day 0, 7, 30, 60, 90, 120, 150, and 180
Knee joint function as assessed by the change in the WOMAC - Physical
function (WOMAC-PF) score.
Day 0, 7, 30, 60, 90, 120, 150, and 180
Knee joint pain assessed by the change in the Visual Analogue Scale (VAS)
score.
Day 0, 7, 30, 60, 90, 120, 150, and 180
Severity of osteoarthritis as assessed by the change in the Lequesne
algofunctional index (LAI) score.
Day 0, 7, 30, 60, 90, 120,
150, and 180
Overall health of the participant as assessed by change in the Participant’s
Global Assessment of Osteoarthritis (PGA-OA)
Day 0, 30, 60, 90, 120,
150, and 180
Percentage of responders as per OMERACT-OARSI responder index.
Day 180
Cartilage metabolism determined by urine levels of C-terminal cross-linked
telopeptide of type II collagen (CTX-II).
Day 0 and 180
Use of rescue medication.
Day 7, 30, 60, 90, 120, 150, and 180
Knee joint health as assessed by the change in total WOMAC score
Day 0, 7, 30, 60, 90, 120, 150, and 180
Target Sample Size
Total Sample Size="255" Sample Size from India="255" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="236"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This study is a randomized, double-blind study to evaluate efficacy and safety of the investigational product in individuals with grade II or grade III osteoarthritis of the knee. The study has three arms; investigational product arm, glucosamine hydrochloride + Chondroitin sulfate arm and placebo arm. 255 participants will be randomized into the 3 arms of the study.
The Investigational product is Collavant n2, which consists of type II native collagen. The main aim of this study is to assess the effect of Collavant n2 on various aspects of joint health as compared to placebo and glucosamine arm